At Celgene, we are focused on our mission - delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases. Apply today to Clinical Jobs, Regulatory Jobs, Marketing Jobs, Biostats Jobs and more!en-usjobs.celgene.com720Job Title: Director, Global Regulatory CMC
Job ID: 12284
Location: Basking Ridge, NJ -110
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Global Regulatory CMC - 3258


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BS/BA degree in Scientific Discipline (Masters or higher preferred) with
8-10 years in the pharmaceutical industry or in CRO, including 5-7 years CMC regulatory (biologics preferred) experience

Responsibilities will include, but are not limited to, the following:

1. Responsible for the development of the CMC regulatory strategy for submissions. These submissions include IND/CTA/BLA, NDA, CTD and MAA regulatory filings.
2. Coordinate the preparation and review CMC submission documents, registration dossiers, and responses to health authorities with other relevant line functions.
3. Responsible for the regulatory evaluation of CMC change controls.
4. Responsible for the management of CMC activities related to specific developmental or commercial compounds.
5. Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs teams. In addition
6. Take on leadership role in the CMC development/commercial teams.
7. Interact with regulatory agencies and represent CMC at regulatory agency meetings.


Skills/Knowledge Required:
- Must have experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses and IND/CTAs)
- Experience in the development of CMC regulatory strategy
- Knowledge of FDA, EMEA and ICH guidelines.
- Knowledge of rest of world post approval guidelines
- Have a solution-oriented approach to problem solving
- Expertise in either the drug development process or post approval activities
- Ability to work on complex projects and within cross-functional teams
- Prior supervisor or project management experience
- Experience with CMC regulations for biological compounds.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120201
]]>http://jobs.celgene.com/job/Basking-Ridge-Director%2C-Global-Regulatory-CMC-Job-NJ-07920/1388040/138804013880402012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSBasking Ridge, NJ, USLegal
Neuchatel, Switzerland

PREREQUISITES

Minimum 2 years experience in contract management, as a paralegal or equivalent experience at a major law firm or in-house at a multinational Company. German is an asset

Valid Swiss working permission or EU Citizenship required

Under the supervision of the Manager Legal Contracts, the successful candidate will play a key role in the efficient management of contracts as an integral member of the Contracts Team in the Legal Department. He/she will be responsible for the preparation, review, and tracking of a variety of high volume, standard agreements such as Confidentiality Agreements, Consulting Agreements and Services Agreements. Must possess the ability to meet deadlines and to manage priorities, clients’ needs and expectations and be willing to work in an international environment where individual initiative and accountability to the team are required.

Responsibilities include, but are not limited to:

- Using approved templates, drafting, reviewing and negotiating confidentiality and nondisclosure agreements, consultancy agreements, service agreements and other types of agreements with some supervision and within established guidelines set by the successful candidate’s manager and the lawyers in the Legal Department.
- Managing incoming internal client requests for contract generation and Legal review and approval, using software based contract management tool.
- Requesting further information and data required by Legal Department from internal clients and external parties.
- Tracking contracts and other task requests, work in progress and completed agreements and creating periodic reports of the tracker to share internally.
- Coordinating lawyer review of non-template and non-standard agreements or provisions.
- Appropriately referring legal and process issues to manager and/or other lawyers in the Legal Department for review and direction.
- Working closely with internal clients to understand business objectives and desired business expectations and address identified issues and concerns.
- Using approved training materials, provide training to internal clients on contracts and the contract process.
- Coordinating with Legal staff to identify client needs and support for continuous improvement of contract processes, policies and templates.
- Ensuring compliance with policies and procedures, ethical practices, company values, and adherence to relevant laws and regulations.

Skills/Knowledge Required:

- Qualified through education, training and/or work experience including legal review of contracts, and management of organizational processes and negotiation.
- Excellent writing and editing abilities.
- Excellent planning & organizational skills and an ability to work with minimum supervision.
- Understanding of legal concepts and terminology.
- Interpersonal skills to work as a team-player and to effectively work with people of diverse rank and culture across a variety of business disciplines.
- Ability to quickly grasp business objectives, prioritize and organize work and handle multiple matters simultaneously.
- Ability to work under tight deadlines.]]>http://jobs.celgene.com/job/Neuchatel-Legal-Contract-Specialist-%28paralegal%29-Job/1388046/138804613880462012-06-14Celgene CorporationLegalfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Senior Manager, Clinical Contracts
Job ID: 12198
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Clinical Operations - 3603


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

8+ years in the Pharmaceutical Industry; 4+ years performing clinical contracting, BA/BS degree in life sciences, business, finance or equivalent, or
MBA/MS/JD, 4+ years in the Pharmaceutical Industry; 2+ years in performing clinical contracting, preferably contract management/procurement/paralegal/business development/relationship management)

Responsibilities will include, but are not limited to, the following:
1. Perform and manage all activities associated with the development and execution of contracts with clinical investigators (sponsored studies and investigator initiated studies) and other contract types as necessary. Manage the contract negotiation process globally, identifying changes to the Legal department and coordinate any changes requested maintaining Celgene’s interests are safe guarded as well as country specific requirements are reflected.
2. Track, manage and monitor all changes to study scope affirming timely amendment finalization and implementation.
3. Work with external site & vendors and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters.
4. Lead and develop relationships with key investigational sites across the contracting and budgeting interface
5. Prepare investigator budgets using industry benchmark database and ensuring fair market value of site budgets, may negotiate costs for clinical contracts. Coaches staff regarding benchmarking and budget related questions.
6. Manage relationships with Celgene staff as well as site personnel. Identify potential risks and manage issue resolution of moderate to high complexity. Create backup plans as necessary.
7. Involved in projects or programs (complex and multiple).
8. Responsible for making decisions & direction of outcomes.
9. Identify new and best practices for continuous improvement.
10. Requires minimal supervision, independently author contractual documents and design and revise templates as required.
11. Able to lead others, provide direction to teams, and coach junior level staff.
12. Member of cross-functional teams; may lead meetings as appropriate and influence line functions
13. Update tracking system with all contracts/cost information.
14. Maintain a web based contract management system and repository of previously negotiated contracts.
15. Train & coach others (i.e. including but not limited to clinical study teams, CROs and other personnel as required) in contract processes and industry practices.
16. Comply with audit requests and compliance training as necessary.


Skills/Knowledge Required:
- Advanced knowledge of contract terms and conditions (T&C) globally
- Advanced knowledge of financial terms, budgets and financial benchmarking tools
- Advanced problem solving skills in a team environment
- Demonstrated ability to work in a matrix organization
- Excellent negotiation or influencing skills; Ability to establish and influence timelines and expectations
- Proficient in drug development process including GCP and industry practices
- Competent in computer skills, oral & written communication & multi-tasking
- Ability to manage personal timelines and provide input to support staff timelines
- Good understanding of Project Management Principals
- Customer focused and solution oriented

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Senior-Manager%2C-Contracts-Job-NJ-07901/1388052/138805213880522012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSSummit, NJ, USJob Title: Manager, Manufacturing (Aseptic)
Job ID: 12475
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Manufacturing - 1101


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Requires a Bachelors degree in a related field from an accredited college or university with a minimum of 10 years related experience in a regulated industry, preferably a pharmaceutical environment, including 5 years of progressive management experience.
- An equivalent combination of education, experience and training may substitute.

The Manager, Manufacturing is responsible for the overall management, direction and coordination of production personnel and processes and is expected to maintain a compliant, effective and efficient operation that meets or exceeds site goals and objectives. Areas of responsibilities include preparation, filling, lyophilization.

- Maintain manufacturing areas that are compliant, efficient, effective and safe.
- Ensure adequate systems, procedures, personnel and equipment are in place to effectively manufacture bulk product, clean/store/prepare equipment and components, fill/cap/lyophilize/aseptic products.
- Assist in establishing manufacturing department goals that support site goals. Ensure employees have the resources needed to meet or exceed their goals. Provide senior management with monthly updates.
- Assist in developing a manufacturing budget that supports the production plan. Be accountable for variances. Provide senior management with monthly updates.
- Identify owners and technical reviewers for all manufacturing SOPs. Mentor owners and reviewers to ensure procedures are compliant, efficient and effective.
- Select and foster a well trained, motivated and informed staff. Ensure adequate trained personnel are available to perform all manufacturing activities. Mentor Supervisors. Conduct department meetings. Work closely with Human Resources on Policy changes, interpretation and execution; Hiring of new employees, Employee disciplinary action, Performance Appraisals and Personnel Development.
- Work closely with Engineering/Maintenance to reduce downtime, improve equipment reliability. Assist with design of new systems/facilities related to the Department.
- Work closely with Material Management and Quality regarding component problems and maintaining Production Stores/Warehouse inventory.
- Work closely with Environmental, Maintenance, Metrology, and Validation departments to ensure Area Environmental monitoring, PM, Calibration and Re-Qualification schedules are met.
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Manager%2C-Manufacturing-%28Aseptic%29-Job-AZ-85001/1471419/147141914714192012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USQuality Assurance
Neuchatel, Switzerland

Purpose of the position

The position is involved primarily with quality assurance (QA) review batches of commercial drug product

The position will support QA activities on the manufacturing site in Boudry

Responsibilities include, but are not limited to:

- Responsible for the review of executed batch records for accuracy and compliance
- Ensure that the deviations are captured in Celgene GM system
- Prepare the release dossiers
- Update and/or create the SOPs
- May participate in small projects
- Keep up to date records of the office
- Assist the QA team when assigned
- Maintain confidentiality in all aspects on the firm dealing and working

Skills/Knowledge Required:

- BS/BA in life science, medically or relevant discipline
- A first relevant experience in the pharmaceutical industry
- Knowledge of the cGMP and their practical application in pharmaceutical company
- Good written and verbal communication skills, computer skills and attention to detail are necessary
- Must be able to work as a team and as an individual within a multicultural team
- Solid understanding of manufacturing process
- Strong identification with Celgene’s values]]>http://jobs.celgene.com/job/Neuchatel-QA-Sr-Analyst-QA-Analyst-Batch-Release-Office-Job/1489653/148965314896532012-06-14Celgene CorporationQuality Assurancefull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Senior Director, Medical Affairs Disease Team Lead - US
Job ID: 12587
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Medical Affairs
Department: Medical Affairs Leadership - 3609


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

We currently have three Medical Affairs Senior Director openings in the areas of MM, MDS&AML, and CLL.


Skills/Knowledge Required:

- Knowledge and experience in hematologic malignancies
- 10+ years of experience academia/industry with a minimum of at least 5 years in industry
- Intimate working knowledge of the role of Medical Affairs within industry
- MD preferred, however not required if demonstrated record of success and impact within medical affairs
- Strong interpersonal skills and demonstrated success achieving results through cross-functional matrix teams
- Experience in and/or accountability for multiple geographies preferred

Summary/Scope:

- Create and enable the Disease Strategy, working closely with all U.S. regional Medical Affairs stakeholders to synthesize insights and unmet medical needs into a cohesive strategy. Where regional differences exist, assure that the unique needs of each region are accounted for in the Disease Plan.
- Drive creation and oversee execution of the following strategic plans:
- Publication Plan (partner with Scientific Communications)
- Open Research Questions (partner with Project Team Leader/Clinical Development)
- KOL Plan
- Global Training Plan and Platform Materials for Disease State and Products (to be adopted/adapted by the regions)
- Drive research strategy and implementation reflective of Disease Plan and Open Research Questions that seeks to optimize product profile and assure appropriate access to patients world-wide for Celgene products relevant to disease.
- IIT Plan
- Celgene sponsored non-registration trials
- Secondary analyses of primary data
- Registries and Observational Research
- 3rd Party Databases
- Translational Research
- Drive major U.S. Congress Planning, strategically targeting relevant meetings and assuring data for Celgene products meets strategic objectives. Assure excellent preparation for KOL management at specific Congresses.
- Oversee KOL Management Process for the Disease state
- Assure all publications (Abstracts, Manuscripts, etc) are consistent with Disease Strategy as outlined in Publication Plan, accountable for sign-off of all publications.
- Partner with Scientific Communications to create effective presentations and tools that can be adopted and/or adapted globally (RML tools, training platform materials, etc).
- Provide disease and product training to key internal stakeholders.
- Coordinate plan for patient access programs ATU, NPP, etc; execution remains at local level.
- Key external spokesperson to KOLs, Payors, Professional Societies, and Advocacy Groups. Key internal contact and manager for Advocacy groups of global importance.
- Key Member of Business Development team related to disease, driving gap analysis, assessing opportunities, and advocating for specific projects that meet Disease Strategy.
- Represent GDT at key internal governance bodies, including GDT Steering Committee, HODC, and PRC.

Key Documents/Plans Deliverables

- Development of Disease Plan
- Publication Plan (Partner with Global Scientific Communications) and sign off on all publications
- KOL Plan and oversight of execution of KOL Plan
- Open Research Questions (Partner with Project Leader/Clinical Development)
- Congress Plan

Key Relationships

- Global Commercial Leader
- Regional MADLs
- Global Scientific Communications
- Global Clinical Research and Development
- Global Market Access
- Global Project Team Leader
- Translational Research
- Business Development

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Executive-Director-Global-Medical-Affairs-Disease-Team-Lead-MDS-AML-Job-NJ-07901/1505132/150513215051322012-06-14Celgene CorporationMedical Affairsfull-timeUSDstarting0BSSummit, NJ, USJob Title: Scientist II, Analytical Research & Development
Job ID: 12582
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Research
Department: Analytical Research & Dev - 3202


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Completed BS in Chemistry (or relevant discipline) and minimum of 10 years of pharmaceutical laboratory experience required; or

Completed MS in Chemistry (or relevant discipline) and minimum of 8 years of pharmaceutical laboratory experience required; or

Completed Ph.D. in Chemistry (or relevant discipline) and minimum of 3 years of pharmaceutical laboratory experience required.

The successful candidate will be responsible for conducting laboratory research and routine analysis under minimal guidance and oversight from his/her supervisor.

Responsibilities will include, but are not limited to, the following:

Provide supervision to scientific staff in method development and validation for the analysis of starting materials, intermediates, and finished products in accordance with cGMP regulations, established protocols, and all applicable SOPs.

- Ensure that all facilities, equipment, and daily activities are and remain in compliance with cGMP regulations, relevant FDA guidelines and appropriate SOPs
- Develop, optimize and validate analytical methods
- Qualify/transfer analytical methodology to quality control or contract laboratories
- Support drug product development and characterization of drug substances and impurities.
- Review analytical data
- Act as or assist analytical project team leader to meet CMCDT deliverables
- Require hands-on involvement in the laboratory
- Prepare documents and reports


Skills/Knowledge Required:

- A comprehensive knowledge of chemistry and pharmaceutical sciences
- In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidances a must
- Familiar with USP and other compendia
- Extensive hands-on experience and knowledge of separation techniques such as HPLC and GC is a must.
- Knowledge of Dissolution methods developing and testing.
- Strong analytical problem-solving and troubleshooting skills.
- Ability to critically assess projects and formulate new ideas to increase success.
- Good verbal/written communication and interpersonal skills as a team player
- Ability to work independently with minimal supervision

Ability to actively represent the Department on multi-disciplinary and cross-functional teams

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Scientist-II%2C-Analytical-Research-&-Development-Job-NJ-07901/1506866/150686615068662012-06-14Celgene CorporationResearchfull-timeUSDstarting0BSSummit, NJ, USJob Title: Principal Scientist, Medicinal Chemistry
Job ID: 12602
Location: San Diego, CA
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Research
Department: Medicinal Chemistry - 3264


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

PhD in Synthetic Organic Chemistry with 10-13 years of industry experience.

Position Summary:

The qualified Principal Scientist candidate has a PhD in synthetic organic chemistry with 10-13 years of industrial experience in medicinal chemistry and drug discovery with a track record of significant achievement. The candidate should have an extensive knowledge of compound design and lead optimization, as well as a thorough knowledge of contemporary synthetic organic chemistry. It is expected that the role will impact multiple projects from lead identification through clinical candidate nomination with innovative and optimized compound designs. The candidate is expected to have extensive knowledge and experience in synthetic chemistry, structure based drug design (SBDD), fragment based drug design (FBDD), lead identification/optimization and SAR analysis. She/he will actively participate in all aspects of drug discovery programs and is expected to have significant understanding of in vitro and in vivo pharmacology, pharmacodynamics and pharmacokinetics principles, ADMET concepts, discovery safety, and pharmaceutical properties.


Responsibilities will include, but are not limited to the following:

- Design, optimize and propose syntheses for small molecule inhibitors based on multi-dimensional analysis including physicochemical properties, SAR, SBDD, FBDD, DMPK, safety, and/or pharmacology data aligned to project goals
- Visualize and evaluate data and provide impactful hypotheses for the design and optimization of novel, drug-like chemical entities
- Successfully apply multivariate analysis to resolve project issues
- Balance compound properties, identify property issues and propose solutions
- Deliver compound and library designs and synthetic approaches for multiple projects
- Effectively work on chemistry teams and provide input on team tactics and strategy by applying state-of-the-art modeling and informatics approaches
- Provide scientific leadership in solving property/design issues for multiple target and project teams
- May coordinate internally and external chemistry strategies
- Impactful interaction on a multi-disciplinary project teams
- May serve as a project leader
- May superviseindividuals or a team
- Hands-on synthetic chemistry knowledge and problem solving
- May manage external collaborations and CRO’s.


Skills/Knowledge Required:

- Extensive synthetic chemistry expertise with a proven track-record on small molecule drug discovery projects as evidenced by project impact, publications and patents
- Expert level of experience in modern medicinal chemistry and drug discovery techniques (including lead identification/optimization, FBDD, SBDD, multivariate analysis and visualization tools)
- Expert knowledge in applying the state-of-the-art molecular modeling and chemoinformatics to drug discovery
- Extensive experience with commercial modeling, data mining and chem-/bioinformatics software such as MOE, Openeye, Seurat, Gaussian, Schrodinger, Accelrys, Tripos, Spotfire, and Pipeline Pilot
- Expert knowledge of protein dynamics and compound molecular properties
- High level of knowledge of drug discovery targets, biochemistry, pharmacology, DMPK, discovery safety, and pre-clinical development
- Expert level ability in literature searching using common chemical and literature databases such as SciFinder, MedLine, etc.
- Knowledge of IP-related issues
- Able to assimilate ideas from multiple sources including the patent and scientific literature
- A working knowledge of structural alerts, chemical stability, compound liabilities, organic chemistry, and synthetic do-ability
- Knowledge of the pharmaceutical industry and clinical development process
- Excellent oral and written communication skills
- Effective team building and teamwork skills
- Detail-oriented with the ability to identify and implement creative solutions
- Ability to prioritize and manage time efficiently
- Previous experience with supervision and mentoring of laboratory, support and scientific staff
- Strong interdisciplinary interaction skills
- Project leadership experience

Other Attributes:

- Recognizes risk and presents alternatives consistent with industry and company protocols
- Demonstrates independent, scientifically-directed, and innovative thinking
- Facilitates growth of less experienced scientists
- Keeps management abreast of current science
- Advises the chemistry management team on departmental goals
- Recognizes interrelationships of facts/factors, processes, and systems
- Communicates effectively within the larger organization
- Develops constructive relationships across the organization to achieve goals through leadership roles on cross-functional/divisional teams
- Possess an entrepreneurial approach
- Demonstrates compliance with all safety protocols and policies

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/San-Diego-Principal-Scientist%2C-Medicinal-Chemistry-Job-CA-92101/1508446/150844615084462012-06-14Celgene CorporationResearchfull-timeUSDstarting0BSSan Diego, CA, US
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Apply Without Selecting Job]]>http://jobs.celgene.com/job/Phoenix-Analyst%2C-QC-Systems-%28Informatics%29-2nd-Shift-Job-AZ-85001/1526736/152673615267362012-06-14Celgene Corporationfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Lead Analyst, IT (ERP)
Job ID: 12659
Location: Basking Ridge, NJ -106
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: IT–Global Architecture & Admin - 4171


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

In order to apply for open position, you must be currently performing at an Achieves Expectations (AE) level or better, have been in your current position for a minimum of one year* and meet the requirements of the position for which you are applying, except in certain cases of employees applying for positions within their own department.

Employees may apply for one position at a time. Relocation assistance is typically not provided on an employee-initiated job posting. Trans-continental moves will only be initiated through Celgene's Talent Planning process.

- You must notify your supervisor before applying for this position.

Seeking an individual with 8+ years experience in ERP technical leadership and architecture.

Responsibilities will include, but are not limited to, the following:

- Use of an Application Architecture with the following practice areas:
- Business
- Applications
- Information
- Technology

- Provide leadership and direction as it relates to technical design and implementation for ERP
- Optimization of information management approaches through an understanding of evolving business needs and technology capabilities as they apply to applications.
- Ensure that projects do not duplicate functionality or diverge from each other, and business and IT strategies.
- Provide maintenance and support during deployment, upgrade and any changes to ERP and/ or during other enterprise activities that impact ERP infrastructure
- Oversee, recommend and implement appropriate solutions and enhancements to ensure an improvement in system reliability and performance
- Work with IT functional and technical analysts to provide consensus based ERP solutions that are scalable, adaptable and synchronized with evolving business needs.
- Manage the risks associated with ERP systems as an asset through appropriate application of standards and security policies.
- Ability to work on multiple projects simultaneously
- Enforce technology/process standards across the enterprise and liaise with IT infrastructure as required
- Influence and drivs investments into new ERP technologies and innovative ERP solutions
- Participate and lead design for new CEMLI / RICE elements related to ERP.
- Define and lead capacity management monitoring and make recommendations for enhancements/ improvements

Working Experience and Education

- Master’s degree in Business or Information Systems.
- 8 to 12 years of overall work experience including :
- 8 years architecture development experience and / or pharma experience
- Specialization and experience in ERP solution architecture and technical leadership

Skills and Knowledge

- Full functional knowledge of the standard four practice areas
- Business:
- Strategy maps, goals, corporate policies, Operating Model
- Functional decompositions, capabilities and organizational models
- Business processes
- Suppliers of hardware, software, and services

- Applications:
- Application softwareinventories and diagrams
- Strong ERP technical background, Oracle EBS/SAP preferred
- Interfaces between applications– i.e., events, messages and data flows
- Interfaces with parties within and outside of the organization e.g. FTP, EDI

- Information:
- Metadata- data that describes your enterprise data elements
- Data models: conceptual, logical, and physical

- Technology:
- Hardware, platforms, and hosting: servers, and where they are kept
- Localand wide area networks, Internetconnectivity diagrams
- Operating systems
- Infrastructuresoftware: Application servers, DBMS, SOA
- Programming languagese.g. PLSQL, ABAP

- Strong oral and written communication skills, presentation and facilitation skills
- Strategic, critical and innovative thinking, problem solving and analytical skills
- Team player, open minded and viewed as a subject matter expert
- Capable of working effectively with a variety of stakeholders
- Builds and enables an effective and supportive environment for the discussion of systems and application opportunities.
- Capable of communicating a strategic vision across interdisciplinary teams
- Advanced knowledge and practical experience with software, hardware, and network engineering

J2W:20120412
]]>http://jobs.celgene.com/job/Basking-Ridge-Lead-Analyst%2C-IT-%28ERP%29-Job-NJ-07920/1541637/154163715416372012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBasking Ridge, NJ, USJob Title: Associate Director, Data Management
Job ID: 12670
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Clinical Data Ops Sys&Standard - 3612


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

- BA/BS in a relevant scientific discipline; minimum 12 years experience in data management roles, including at least 5 years of management experience in a pharmaceutical/CRO.
- Demonstrated management skills and experience leading a team
- Knowledge of Drug Development process
- Good communication skills; ability to work in a team environment
- Strong analytical skills
- Knowledge of FDA/ICH guidelines and industry standard practices regarding data management
- Knowledge about requirements of New Drug Application (NDA)/Market Authorization Application (MAA) submission to authorities
- Previous experience with CDM systems including EDC; sound understanding of database and programming concepts, database structure
- Previous experience at or oversight of outside Clinical Research vendors (CRO’s, Central Labs, Imaging vendors)

Resource planning/management experience

Summary:

- Manage and support a group of Clinical Data Managers while prioritizing and directing resources requirements across multiple projects in assigned Therapeutic areas, according to SOPs, guidelines and regulations. Also participate in budgeting and forecasting for CDOSS department resources.
- Direct responsibility for supervising Data Managers in the performance of their duties with overall project priorities and timelines
- Manage resources and staff workload for their assigned projects. Ensure studies are resourced appropriately
- Manage , mentor, and evaluate performance of Data Management staff, including setting-up goals and objectives, conducting performance evaluations, and providing staff with guidance on technical/project related issues, people development
- Ensure Data-Management staff adheres to SOP and working practices for their assigned projects
- Participate in developing, defining, maintaining, and enforcing Data-Management standards
- Ensure process and standards are being followed and initiate process improvement activities if necessary
- Ensure appropriate interactions occur with personnel from other groups, such as Biostatistics, Clinical Programming, Clinical Development, Quality Assurance
- Liaise with third party vendors, such as CRO’s, EDC in a project management capacity
- Maintain forecasting for Data-Management resources.
- Manage recruitment process in collaboration with Recruiters and Human Resources
- May participate in cross-functional process improvement initiatives
- Stay abreast of industry developments in the Clinical Data Management field and apply to appropriate systems or processes

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Associate-Director%2C-Data-Management-Job-NJ-07901/1550955/155095515509552012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSSummit, NJ, USJob Title: Therapeutic Manager - Medical Information
Job ID: 12697
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Medical Affairs
Department: Medical Information - 4201


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Pharm.D. or Ph.D. in a pharmaceutical science required
- RPh or RN with previous pharmaceutical industry-based Drug Information experience considered
- 1-4 years of Drug Information, or related Clinical Pharmacy Practice/Managed Care experience
- Drug Information or clinical residency desired
- 2+ years of clinical experience preferred
- Relevant therapeutic background desired

Monitors the medical literature/guidelines for company product(s) and relevant competitor data; analyzes the information for accuracy and relevance and appropriately synthesizes the data for inclusion in standard/custom responses and other educational materials. Provides written or verbal responses to individuals requesting medical information by evaluating the scientific merits of published information and extracting pertinent data from the scientific literature. Serves as a therapeutic team resource for product information for both internal and external customers and participates in cross functional initiatives such as publication planning, copy review, etc, as appropriate.

Core Responsibilities:

1. Searches, reviews, and summarizes the available data in the published literature, medical textbooks and internal documents to develop standard responses to requests for information on the clinical activity or potential application of marketed/investigational products. Revises standard Medical Information letters to ensure responses reflect all currently available medical information. Reviews and edits standard responses developed by peers.
2. Researches and prepares customized responses to medical information inquiries escalated from the front line team.
3. Conducts preliminary review to ensure clinical accuracy of materials produced by internal business partners (e.g. Medical Affairs slide decks, Scientific Communications manuscripts, copy review materials)
4. Represents Medical Information at interdisciplinary meetings and related initiatives to provide product information on the company’s products.
5. Provides written and verbal responses to inquiries from health care professionals, consumers, and internal business partners requesting medical information related to Celgene products.
6. Utilizes the appropriate information resources to identify published literature and respond to medical information inquiries; accurately and comprehensively transcribes all aspects of the interaction within the Global Medical Information database.
7. Assists Medical Information Specialist with challenging requests for medical information; provides direction for how to handle specific calls. Responds directly to inquiries as needed
8. Provides support for sales training initiatives for current products and drug product launches by reviewing and creating sales training materials and participating in clinical product training for sales representatives and others.
9. Independently prepares for and attends medical conferences to provide complete, accurate and timely medical information to healthcare professionals at the conference booth. Serves as conference lead to coordinate Medical Information/Medical Affairs activities.
10. Assumes the lead on key projects for the Medical Services Department and coordinates with interdisciplinary partners as required.
11. Performs other responsibilities as assigned by supervisor.
12. Participates in on call schedule to provide 24-hour medical information coverage, as needed.

Other Responsibilities

1. Conducts business in accordance with Celgene Values. Completes all assigned SOPs and training within designated timeframe and adheres to job-specific SOPs and work instructions.
2. Identifies, obtains pertinent data, and accurately processes any reported adverse events (AEs) and product quality complaints (PQCs) to Drug Safety and Quality Assurance Complaint department, respectively, in accordance with policy and procedures.
3. Conducts/assists with the training of new employees specific to therapeutic area of focus; assists in the overall training of new Medical Information personnel overall and in ensuring key activities are incorporated as part of the training.
4. Attends external meetings and educational seminars to enhance therapeutic area knowledge and broaden pharmaceutical industry experience.


Skills/Knowledge Required:

- Must be a team player and be willing to work in an environment where individual initiative and accountability to the team are required.
- Must be able to work with limited day-to-day supervision
- Excellent written and verbal communication skills
- Flexible, with positive attitude, strong ability to multi task and prioritize projects effectively
- Familiarity with electronic referencing databases preferred
- Strong PC experience and Microsoft Word experience required
- Strong Access, Excel, and PowerPoint skills desirable
- Some travel required to represent company at medical conferences, presentations, and other meetings

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Therapeutic-Manager-Job-NJ-07901/1576886/157688615768862012-06-14Celgene CorporationMedical Affairsfull-timeUSDstarting0BSSummit, NJ, USJob Title: Manager IT, Email Systems
Job ID: 12748
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: ITGOS Technology - 4163


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Ability to manage staff and projects in multiple locations across the United States and Internationally. 8-10 years Email administration experience in a large corporate environment. Symantec eVault expertise is mandatory. Good knowledge of Blackberry. Provide hands-on assistance as and when necessary until team grows to work independently.

Global Messaging Environment

Responsible for managing the Global Messaging and Collaboration Services Team. Provide leadership to a high performing team and partnering with key stakeholders in both business and technology units across the company. Oversee global messaging team individuals. Lead, manage, and mentor direct reports and their subordinates to optimal levels of performance with heavy emphasis on teamwork and organization. Provide technical vision, architecture, management, and short and long-term direction for all Global, Messaging and Collaboration Services. Work with various IT Teams, and Business partners to drive the delivery of innovative product/services focused on improving business productivity, while reducing operating expense. Design, and implement standards, processes and complimentary services that facilitate business agility, and the efficient use of technology investments.

- Provide the company with expert opinion on new and emerging technologies that may assist in the planning and implementation of addition, deletion and major modification supporting of a cost effective infrastructure.
- Implement current knowledge of relevant technology, keep abreast of the new and emerging technologies and determine the effective and beneficial use for the added value and cost effectiveness.
- Develop comprehensive strategy in alignment of the IT objectives and recommend purchases of technology that will increase business efficiency, save money and facilitate corporate expansion.
- Contribute in developing the Mix of In-house versus the Outsource services and Implement the Mix to optimize the cost of IT services.
- Define, adjust, and maintain IT standards.
- Defines resources and schedule for project/program implementation.
- Create strategies for risk mitigation and contingency planning.
- Plan and schedule project deliverables, goals, milestones.
- Direct and oversee project engineering team and manage conflicts within group.
- Perform team assessments and evaluations.
- Efficiently identify and solve project issues.
- Demonstrate leadership to define requirements for project risk.
- Identify and provide standards for gathering information for use in trend analysis and reports information to company management
- Making IT resources and the messaging system available round the clock and establish disaster recovery or contingency plans to assure business continuity.
- Direct engineering of global messaging platform capabilities
- Introduce innovative solutions that will help provide the foundation for the next generation of business applications
- Design and deliver programs, processes and procedures resulting in continuous product enhancements, service delivery improvements and user satisfaction.
- Work closely with multiple vendors to help drive service level agreements down and speed up delivery. Assure the company has in time the best available resources and the products.
- Create a culture that fosters learning and development; values and rewards technical excellence.
- Responsible for recruitment, development, motivation, and retention of assigned staff.
- Partner in the technology budget preparation and implementation to adhere to the budget goals through cost control and by maintaining the IT assets responsibly.
- Provide timely status communication and updates to IT Infrastructure Management, especially in case of problems or incident. This includes clear ‘post mortem’ documentation.

EVault (Symantec)

- Taking ownership of the EVault (Symantec) system.
- Manage the project to eliminate PST files by importing them into Enterprise Vault system.

Blackberry (RIM), Anti-Spam (Postini), Anti-Virus (McAfee)

- Providing leadership and technical guidance to the Blackberry, Postini & MacAfee environments.
- Looking at other anti-Spam measures such as Support a Google mail and Exchange intelligent message filter.

Infrastructure

- Manage Global Corporate Email infrastructure environment.
- Manage email DR capabilities in relation to the IT resource at the DR location.
- Oversee the monitoring of email performance at all environments to allow the establishment of a recommended roadmap of system upgrade/replacement schedules etc.

Knowledge transfer - training

- Sharing knowledge on Exchange, Blackberry, Postini and eVault with designated individual in the Infrastructure Group.


Skills/Knowledge Required:

- Strong, technical working knowledge of Windows Operating Systems, Microsoft Exchange, Symantec Enterprise Vault, Blackberry, MS Office Communication Server, and associated Office products.
- Hands on experience managing a customer facing, mission critical operation that is directly driven by customer satisfaction.
- Ability to design, implement, and administer Microsoft Exchange 2003/2007 solution for corporation.
- Architect level knowledge to design, implement , and administer Symantec 8.0 Enterprise Vault and Discovery Accelerator.
- Must have proficient knowledge of writing custom/advanced scripts using, VBScript, WSH, WebDav, and Powershell.
- Demonstrated understanding of various Collaboration tools, technologies and associated services.
- Must have proven ability to lead or approve the direction of a wide range of diverse issues such as product direction, alternative implementation approaches, and resource negotiation
- Significant experience with all aspects of technology life cycle including planning, acquisition, introduction, operations and retirement
- Management experience with technical delivery teams in business-facing roles
- Experience driving and implementing new technologies and processes in large environments
- Track record of planning and delivering on time and on budget
- Proven ability to evaluate and manage risk
- Experience in world-wide multinational organizations
- Ability to create TCO models and determine ROIs when making technology decisions
- Experience working with off-shore and or 3rd party service providers.
- Demonstrated ability to motivate, negotiate, and achieve consensus
- Strong problem resolution skills and a Can Do approach to getting the job done.
- Self-starter that demonstrates initiative and ability to work independently with little supervision.
- Promotes an organizational climate that energizes, motivates and facilitates teamwork; encourages responsible risk taking.
- Makes a point to move throughout the organization in an effort to encourage open and cross-functional communications.
- Able to quickly learn a broad array of collaborative technologies and apply knowledge to real-world problems;
- Effective under aggressive timelines and high pressure situations.
- Known to deliver clear understandable instructions and coaching to others within the team.
- Ability to grow and mentor new and existing staff members to be productive technology leaders.
- Proven project management and customer service skills; demonstrated planning and organization skills.
- Excellent written and verbal communications; effective interpersonal skills; strong formal presentation abilities.

Education/Experience:

- Candidates must have a BS or BA in Computer Science, Information Systems, or demonstrated equivalent experience. MS in Computer Science or Information Systems is highly preferable.
- Must have experience in leading and motivating complex teams to achieve on-time completion of projects.
- Strong written, oral and interpersonal communication skills are needed.
- Organizational "Fit" Considerations: The candidate must be flexible to take on different tasks at short notice and have the ability to function in cross-functional team setup that consists of different disciplines. Prospective candidate must be able to work in a fast paced environment.
- Solid experience with multi-server environment/ deployments
- 10+ years experience supporting a global Microsoft Exchange, Blackberry, and Symantec Enterprise Vault environments, which includes design, deployment, troubleshooting and platform analysis
- At least 10 years experience supporting 100+ server environment with 30000+ users
- Pharmaceutical background highly preferred. Understanding of the CFR Part 11 and Sarbanes-Oxley regulatory requirements and experience with processes and procedures to apply and administer these and other necessary regulatory requirements in an operational environment
- Experience with working in validated environment, standard network change management, access control mechanisms and configuration policies in pharmaceutical environment.
- Must have experience in mail systems migrations between companies.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120402
]]>http://jobs.celgene.com/job/Berkeley-Heights-Manager-IT%2C-Email-Systems-Job-NJ-07922/1658794/165879416587942012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Director, Organizational Development & Effectiveness (OD&E)
Job ID: 12749
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Human Resources
Department: Global Human Resources - 4103


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

- Completed Masters degree in Organizational Development or related field required.
- At least 9 years of progressive responsibility in the field of organization development and talent management are required.
- Must have a track record of achievement in designing and implementing organization development & talent management initiatives in a corporate environment (generally Fortune 250), preferably in the pharmaceutical / biotech industry.
- Experience implementing solutions in a global environment (multiple sites, multiple countries) required.
- Experience in effectively interacting with and influencing senior level HR and business/function leaders required.

Summary:

Purpose of the Organizational Development & Effectiveness Group at Celgene:

To provide thought leadership, deep expertise, processes, tools, and resources in achieving the Corporate Objectives by partnering with HR Business Partners and Function Leaders in the following:

- Building organization effectiveness
- Building workforce capability
- Building talent pipeline
- Building a culture based on Celgene Values

The group is responsible for driving organization development, talent management and overall learning and development strategies, tools, consulting services, and processes in the following technical areas:

- Organization structure and design
- Performance Management
- Assessments and Multi-rater feedback
- Change management
- Team effectiveness
- Employee engagement
- Succession planning
- Leadership development at the executive, middle manager, and first line leader level
- Workforce Planning
- Organization Diagnosis and effectiveness

Technical capabilities required of the Organization Development & Effectiveness Director:

Talent Management: Demonstrates in-depth knowledge of two or more talent management and leadership development disciplines, including performance management, succession planning, talent planning, assessments, competency development, and executive & leadership development.

- Independently designs moderately complex talent management and leadership development solutions / systems leveraging knowledge of required supporting structure(s). Analyzes and makes recommendations regarding supporting technology solutions.
- Makes recommendations on use of appropriate tools for various assessment situations. Uses talent review and data from multiple businesses to determine individual and organization development needs.
- Initiates and designs complex leadership development solutions.

Organization Development: Demonstrates advanced knowledge and experience with respect to two or more Organizational Development content areas: Organization design, change management, organization and team effectiveness, organization diagnosis and effectiveness interventions, work process improvement, employee engagement and culture change.

- Facilitates use of OD tools and techniques in support of business needs. Acts as a key contributor to complex and/or critical Organizational Development interventions to support the HR Business Partners and function leaders. Creates tools, models, training programs, etc. that build the capability of the Organizational Development team, the HR leaders, and the broad Celgene organization.
- Applies in-depth skills and broad knowledge of the business to address complex organization issues and non-standard situations.

Project Management: Demonstrates excellent project management skills in the management of large scale organization development, talent management, and leadership development projects.

- As project leader, responsible for effective planning, timely delivery, efficient project management, development of assigned consultants, stakeholder management, outcome of results, and overall client satisfaction with the engagement.
- May have other OD&E or Human Resources professionals assigned to project team under this person’s leadership.

Competencies: Demonstrates the following competencies:

Foster Teamwork

- Works as an integral member of the OD&E team; responsible for achieving team goals, providing others with appropriate feedback, sharing expertise, and doing one’s part to improve the overall efficiency of the team
- Partners effectively with internal HR Business Partners

Consultation

- Draws on comprehensive technical knowledge and excellent consulting skills to advise internal/external customers in Organization Development areas
- Recommends methods for improved work processes, detailing the process’s strengths and answering internal/external customers’ questions to gain group consensus
- Effectively negotiates and influences

Drive Execution

- Executes flawlessly to deliver on commitments
- Anticipates and overcomes obstacles in the achievement of complex/multi-dimensional goals/ commitments

Shape Strategy

- Demonstrates the ability to connect data from many different sources and formulate cohesive strategic plans

Demonstrate Adaptability

- Ability to adapt appropriately to changing conditions
- Ability to work constructively under pressure
- Ability to respond resourcefully to change and ambiguity

Organizational Needs Assessment and Diagnosis

- Conducts in-depth diagnostics and analytics to identify gaps between current and end state goals; determines the factors that affect outcomes; build interventions to close gaps

Personal Courage

- Makes difficult, sometimes unpopular decisions, by carefully weighing pros and cons, providing rationale, and acting for the benefit of the organization

Required Skills/Experience:

- Completed Masters degree in Organizational Development or related field required.
- At least 9 years of progressive responsibility in the field of organization development and talent management are required.
- Must have a track record of achievement in designing and implementing organization development & talent management initiatives in a corporate environment (generally Fortune 250), preferably in the pharmaceutical / biotech industry.
- Experience implementing solutions in a global environment (multiple sites, multiple countries) required.
- Experience in effectively interacting with and influencing senior level HR and business/function leaders required.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Director%2C-Organizational-Development-&-Effectiveness-%28ODE%29-Job-NJ-07901/1658795/165879516587952012-06-14Celgene CorporationHuman Resourcesfull-timeUSDstarting0BSSummit, NJ, USDrug Safety
United Kingdom

PREREQUISITES

Valid Swiss working permission or EU Citizenship required

- The medical reviewer is responsible to:
- provide medical advice and input to the activities of AE Case Management
- contribute to global pharmacovigilance & trials activities through ensuring appropriate operational output and support
- act as a significant point of contact between Case Management, Trials and PV

Responsibilities include, but are not limited to:

AE Case Management

Medical Review
- Execute the medical review of serious AE reports (narrative, coding, labeling, causality, company comment)
- Identify SUSARs from blinded clinical studies and initiate unblinding together with Drug Safety Management and Trial Safety Surveillance
- Execute corrections and make updates in ARISg for minor modifications
- Execute corrections and return case to Assessment for major modifications
- Review and update generated follow-up letters as appropriate
- Create and review weekly line listing of non-serious cases
- Manage any changes needed based on weekly line listing review of non-serious cases
- Distribute and discuss cases with other company MDs as needed Workflow Mgmt
- Contribute to the resolution of issues Conventions Maintenance
- Contribute to the creation & updating of conventions/templates Quality Assurance
- Contribute to the communication of quality performance findings

Pharmacovigilance

PSURs or Annual Safety Reports
- Provide input to PSURs or ASRs as required Events of Interest management
- Develop definitions of case follow up needs
- Identification of potential signals during case review with escalation to Lead Safety Product Physicians/PV & EPI as applicable

Compliance, Standards, Training & Project Management

Preparation for Regulatory Inspection

Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandatesInternal Global Safety Department Development

Internal Global Safety Department Development

- Participate in product meetings within the drug safety department

Skills/Knowledge Required:

- Qualifications
- MD in Pharma or Medical field or international equivalent
- Specialist accreditation desirable
- Experience
- Extensive experience in Medical Reviewing
- Experience in drug safety
- Clinical experience preferred
- Knowledge
- Medical aspects of drug safety
- Pre- and post-marketing safety practice
- Regulatory requirements across drug safety
- Clinical development process and operations
- Use of safety data in aggregate analysis

To provide medical advice and input to the activities of AE Case Management, contribute to global pharmacovigilance & trials activities through ensuring appropriate operational output and support and act as a significant point of contact between Case Management, Trials and PV. Please send your letter of application and cv to klavery@celgene.com by Friday 9th March 12.00 NOON.]]>http://jobs.celgene.com/job/Medical-Reviewer-Job/1658818/165881816588182012-06-14Celgene CorporationDrug Safetyfull-timeUSDstarting0BSUnited KingdomJob Title: Product Manager/Senior Product Manager, Market Access (Channel Marketing)
Job ID: 12764
Location: Summit, NJ
Offsite Territory: Category:

Other
Department: Market Access - 2204


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BA/BS required; MBA preferred

The Product Manager of Channel Marketing is responsible for US channel marketing initiatives to successfully drive market share and support sales growth in current indications and help determine strategy for future indications of Celgene hematology/oncology products.

Responsibilities will include, but are not limited to, the following:

1. Develop channel marketing strategy for all Celgene brands /indications
2. Develop, implement, and manage market access initiatives for National Account Managers, Regional Reimbursement Managers and sales representatives
3. Develop, implement, and manage market access initiatives for Celgene Patient Support
4. Work closely with national accounts, reimbursement management, patient support, brand marketing, pricing & contracting, market research, sales management, legal, regulatory and medical to ensure appropriate implementation of channel marketing strategies
5. Monitor the competitive environment, identify opportunities with payers, patient access & pathways
6. Manage external agencies to ensure excellent execution of various market access programs
7. Manage promotional budgets
8. Develop and deliver presentations to internal and external audiences


Skills/Knowledge Required:

- Bachelor’s degree in relevant science or business major, MBA preferred
- Minimum 3-5 years industry experience with 2 years of marketing experience, preferably with at least 2 years of Hematology/Oncology experience
- In depth knowledge of payers, patient access & pathways
- Previous national accounts/channel marketing/managed markets experience
- Demonstrate ability to lead work groups, build alignment, inform, negotiate and collaborate.
- Effective written/verbal communication
- Demonstrate initiative, creativity, strategic capabilities, and ability to work effectively in complex, rapidly changing environments
- Strong project and process management skills, along with the ability to work on multiple tasks, and to effectively prioritize

Proven team player with ability to navigate cross functionally

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120123
]]>http://jobs.celgene.com/job/Summit-Product-Manager-Job-NJ-07901/1668384/166838416683842012-06-14Celgene CorporationOtherfull-timeUSDstarting0BSSummit, NJ, USJob Title: Sr. Manager, Secondary Data & Business Analytics (Onc)
Job ID: 12765
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Other
Department: US Sales Forecasting - 2535


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BS/BA required

The Senior Manager, Business Analytics, will provide secondary data, analysis, and strategic support to the Solid Tumor teams at Celgene. The Senior Manager will participate on cross-functional teams including Marketing, Market Research, Sales Operations, Business Development, Market Access, and Sales.

Responsibilities will include, but are not limited to, the following:

- Provide leadership and effectively manage the secondary market research data function for in-line and near-term pipeline products in the Solid Tumor franchise.
- Manage secondary data resources (e.g., IntrinsiQ, Tandem) and interact with Brand teams, Market Research, Business Intelligence, Forecasting, and Sales Operations to extract meaningful insights on product share, growth and market dynamics.
- Take the lead with cross-functional partners to use secondary data strategically to identify market opportunities and threats.
- Work with Commercial team members to analyze and report integrated data analytics for secondary data resources and other information sources. Act as the key interface for providing this information.
- Investigate new data sources for new products and acquisitions. Lead the Commercial team assessment of third party vendors to determine the best data sources for new markets.
- Work with other members of Business Analytics to utilize EMR/claims data to provide market insights to U.S. Commercial teams.
- Provide updates of relevant secondary data to Marketing, Sales, Investor Relations, Business Development, and other Celgene departments as necessary.
- Assist with updates for Board of Director presentations, earnings release updates, and other key deliverables to Executive Management.
- Ensure secondary data use is consistent with other analytics and reporting across Business Analytics, U.S. Commercial, and Celgene. Respond to questions from the Commercial Team and Executive Management regarding other data sources and industry analyst questions.
- Work with Forecasting team members to understand market trends. Use third party information sources to interpret data for purposes of forecasting.


Skills/Knowledge Required:

- BS/BA required, MBA or advanced degree preferred.
- Strong leadership skills and an ability to work independently.
- Proven track record of working in a matrix organization.
- Excellent organizational skills, with the ability to manage concurrent cross-functional projects.
- Strong analytical/quantitative skills and knowledge, and the ability to understand the big picture.
- Possess the ability to appropriately challenge, ensuring decisions and assumptions are based on best available information.
- Solid oral and written communication skills, with presentation experience to all management levels.
- Extensive knowledge of/experience with pharmaceutical data, oncology/hematology preferred.
- Experience with EMR/claims/reimbursement data preferred.
- Working knowledge of statistical analytical techniques including hands-on experience.
- Advanced Excel, as well as additional PC skills including MS Word, PowerPoint, Access, and SAS.
- 7 to 10 years experience within pharmaceutical / biotechnology industry.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Sr_-Mgr_%2C-Business-Analytics-Oncology-Secondary-Data-&-Analysis-Job-NJ-07922/1668385/166838516683852012-06-14Celgene CorporationOtherfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Associate Manager, Global Supply Chain Planning (2 of 3)
Job ID: 12769
Location: Basking Ridge, NJ -110
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Manufacturing - 1101


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Planner with at least 5-8 year experience in the Pharmaceutical Industry. Bachelors Degree in Business, APICS certification, or equivalent experience is required.

Responsibilities will include, but are not limited to, the following:

1. Analyze and balance critical global factory resources (equipment capacity, materials availability and man power) with customer demand, using MRP to determine global production requirements.
2. Develop, publish and monitor global production plans balancing inventory, resources and capacity, taking into account demand from all sources (i.e.: forecasts, sales orders, supplier managed inventories, stocking programs). This includes drug product and finished goods.
3. Manage the consolidation of global demand forecast requirements from regional Commercial Operations as well as clinical-IMSC demand requirements for assigned commercial products.
4. Work closely with factory and logistics colleagues to ensure that the production plan is achievable through use of capacity planning, level loading, etc.
5. Align production plans with short-term, long-term and strategic needs of Commercial Operations, Technical Operations, and Global Manufacturing. Also ensure production plans are aligned with the Finance’s budget forecasts/commitments and Finance/Treasury strategies.
6. Closely monitors demand forecasts versus actual sales and makes necessary adjustments to production plans in order to maintain inventory levels and customer service.
7. Prioritize product release of finished goods as necessary.
8. Responsible for analyzing global finished goods levels on a monthly basis, to ensure adherence to Sr. Management safety stock policies.
9. Gather timely and detailed data to support the Sales & Operations Compliance reports along with updated supply plan for monthly Sales & Operations Meetings.
10. Gather vital information for Business Reviews meeting along with the analysis of trends for assigned products/markets.
11. Manage the “inventory availability” process for new commercial SKUs for existing brands, and label/PI changes affecting existing or future inventories.
12. Participate on cross-functional meetings as subject matter expert as required.
13. Upon special request, conduct one off analysis as requested by Senior Management for high level business decisions.


Skills/Knowledge Required:

- Planner with a minimum of 3 years of pharmaceutical / process industry experience
- APICS certification is a plus
- Familiarity with Import and Export
- Experience in multiple manufacturing site and/or contract manufacturing environment desirable.
- Must have strong quantitative and reasoning skills, strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
- Detail analysis skills
- Must be able to work with limited day-to-day supervision.
- Strong PC experience, Microsoft Office Suite experience required including; Excel; Outlook; PowerPoint
- Oracle-Advance Supply Chain Planning (or SAP) experience required.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Basking-Ridge-Associate-Manager%2C-Global-Supply-Chain-Planning-%283-of-3%29-Job-NJ-07920/1671884/167188416718842012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSBasking Ridge, NJ, USJob Title: Principal Investigator, Computational Chemistry
Job ID: 12796
Location: San Diego, CA
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Research
Department: Medicinal Chemistry - 3264


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

PhD in organic chemistry, computational chemistry, or a related field, with 12+ years of industry experience

Position Summary:

The Principal Investigator Computational Chemist will be primarily responsible for the delivery of 1) computational chemistry driven molecular design and in silico tools which have high project impact, and 2) the proposal, advocacy, and leadership of new targets and external collaborations that have a high direct impact on departmental and site goals. It is an expectation that the role will be filled by an individual with extensive computational chemistry and drug design experience in the drug discovery/biopharmaceutical industry with a track record of significant achievements. The key deliverable of the role is to build and maintain a computational chemistry group recognized in the industry as state-of-the-art by external bodies.


Responsibilities will include, but are not limited to the following:

The Principal Investigator Computational Chemist will both lead and support activities including, but not limited to;
- Building and maintaining a state-of-the-art computational chemistry group
- Providing technical and people leadership for the computational chemistry group and, where appropriate, within both the chemistry department and for project teams
- Ensuring effective interdepartmental coordination of all in silico work streams related to drug discovery
- The design and/or assessment of effective new in silico tools and their successful implementation
- The successful application of structure based drug design including fragment based approaches
- The impactful delivery of virtual libraries and virtual 2D and 3D screening
- Providing direction for the computational chemistry group including budget preparation and FTE allocation
- The design and optimization of small molecule inhibitors within, or as a leader of, a project team of medicinal/synthetic chemists, biochemists, and biologists using state-of-the-art modeling and cheminformatics approaches,
- The evaluation and visualization of SAR from biochemical screening data which provides impactful hypotheses for the design and optimization of novel, drug-like chemical entities
- Proposing and championing new drug discovery targets that will help deliver both the Celgene mission and fit appropriately within a portfolio of targets
- Proposing and leading external collaborations which both have a direct and indirect impact on project team goals
- The creation and maintenance of a bank of impactful in silico predictive tools
- The successful application of multivariate analysis to resolve project issues

-
Skills/Knowledge Required:

- PhD in organic chemistry, computational chemistry, cheminformatics or related fields with 12+ years of industry experience
- Extensive experience with commercial modeling and data mining software such as MOE, Openeye, Seurat, Gaussian, Schrodinger, Accelrys, Tripos, Spotfire, and Pipeline Pilot, programming skills (e.g. OEChem Toolkit, PERL, Python, Fortran, C++, HTML, CGI, Linux)
- Expert knowledge of the state-of-the-art for computational chemistry and its application in drug discovery
- Expert knowledge of protein dynamics and compound molecular properties
- Able to manage ideas from multiple sources including the patent and scientific literature
- Previous supervisory experience of PhD level scientists
- A working knowledge of structural alerts, chemical stability, organic chemistry, and synthetic do-ability
- Excellent communication skills, both oral and written

Possess an entrepreneurial approach

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/San-Diego-Principal-Investigator-Job-CA-92101/1699084/169908416990842012-06-14Celgene CorporationResearchfull-timeUSDstarting0BSSan Diego, CA, USJob Title: Laboratory Manager, Chemistry
Job ID: 12791
Location: San Diego, CA
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Research
Department: Executive Research - 3201


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

B.S. Chemistry with 8-12+ years of progressive laboratory experience or a Master’s degree in chemistry with 6+ years of progressive laboratory experience (Master’s degree preferred). Ideally, the Lab Manager will have 2-6 years of experience as a synthetic chemist and 5+ years of laboratory management experience, supervising direct reports.

Position Summary:

Celgene is seeking a Lab Manager with a Chemistry degree to lead the lab support team for the Chemistry department. This role is a member of the wider laboratory support team and will supervise other lab support staff such as Lab Assistants and/or Lab Technicians. Knowledge, both theoretical and practical, of chemical structure, nomenclature and chemical reactivity is essential. Expertise with chemical drawing software, and the ability to design and execute searches of chemistry databases is required. The candidate will maintain a departmental chemical inventory and the database/records of the chemical inventory. Familiarity with relational databases and experience with data import/export and report creation is highly desired. A thorough understanding of practical chemical laboratory safety practices is required.


Responsibilities will include, but are not limited to the following:

- Responsible for maintaining data in the chemical reagent inventory database, which includes entry of all necessary structural, catalog and safety information plus generation of inventory-related reports in support of department chemical safety officer.
- Maintenance of the physical chemical inventory, including bar-coding and delivery of daily incoming chemicals, routine re-shelving according to nomenclature- and reactivity-based organizational rules, and annual inventory updates.
- Creation of protocols related to physical chemical inventory and chemical inventory software, including establishing nomenclature- and reactivity-based organizational rules.
- Training of department employees on chemical inventory software use.
- Participating member of a cross-functional and cross-site inventory software team.
- Participating member of the Department and Site safety committees.
- Assist in chemical sourcing and ordering
- Directs and coordinates the laboratory support staff and maintains adequate inventory of common lab supplies and solvents.
- Works on problems of diverse scope.
- Acts as adviser to subordinates to meet schedules and resolve technical problems.
- Provides general/direct supervision to lab support employees.
- Performs performance reviews for lab support staff.


Skills/Knowledge Required:

- Expert level knowledge of organic chemical structure and nomenclature.
- Expert level knowledge of chemical reactivity and compatibility.
- Understanding of chemical synthetic routes and synthetic transformations to support assistance with chemical sourcing of library building blocks.
- Able to solve routine problems and troubleshoot technical issues with inventory software and hardware. Includes ability to communicate effectively with IT and software support staff.
- Good knowledge of chemistry laboratory safety practices.
- Ability to use ChemDraw, or equivalent chemistry drawing program.
- Expertise with use of tools such as SciFinder, Reaxys, Activity Base and Seurat for data mining and report generation.
- Experience with chemical sourcing, including identification of commercial vendors for specific compounds/building blocks.
- Expertise with Microsoft Office Suite of programs including Word, PowerPoint and Excel.
- Excellent oral and written communication skills and attention to detail.
- Strong interdisciplinary personal interaction skills.
- Ability to provide supervision and mentorship.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/San-Diego-Laboratory-Manager-Job-CA-92101/1699085/169908516990852012-06-14Celgene CorporationResearchfull-timeUSDstarting0BSSan Diego, CA, USJob Title: Study Manager
Job ID: 12800
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Clinical Operations - 3603


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Leading one or several cross functional study teams (and/or sub-teams) to deliver clinical research studies on time, within budget and with good quality in compliance with Regulatory Authorities regulations/guidelines and Celgene SOPs/WPs.
- Sharing best practices
- Contributing to process improvement initiatives

Responsibilities may include, but are not limited to, the following:

1. Study Team Leadership- Lead cross-functional study team and/or sub-team, develop, manage and maintain study timelines, minutes, budget and tracking, develop training materials and coordinate training on study procedures, develop study management plan - study specific working practices, develop, manage, and maintain relationships with affiliate offices, develop study execution plans
2. Study Planning - Review and comment on study documents such as synopsis, protocol, ICF and CRFs, develop overall study budgets, recommendnumber of investigative sites, oversee the development of investigational product supply forecasting and management, input on project specifications and feedback on requirements for CTMS, guide structure and oversee set up TMF
3. Selection and Evaluation of Investigative Sites - Participate in country selection, in collaboration with CRP and CRS, identify prospective investigative sites, review feasibility, participate in final investigative sites selection, develop and monitor investigative site budgets and oversee negotiation of financial terms of individual site budgets, manage site payments, monitor GCP/ICH site level compliance
4. Identification and Selection of Vendors - Participate in preparation of RFP, assumptions and SOW,recommend vendors, contribute and review specs for vendors (IVRS, Labs), management of vendor oversight, review and approve vendor invoices
5. Preparation of Study Documentation - Review essential regulatory documents, prepare detailed study timeline, develop and oversee risk management plan (e.g. for poor enrollment), prepare, review and approve Monitoring Plan, assure adherence to Monitoring Plan, review eCRF specs (EDC) and review of CRF completion guidelines, design, review and approve study tools (for investigative site use), create study team contact roles and responsibilities, review DM documents (CRO and in-house studies), facilitate Development and Review of Data Review Plan
6. Input Clinical Database, Safety and CSR Reports - Review edit specifications (paper and EDC), execute EDC User Acceptance Testing (UAT) scripts, facilitate development and review of Clinical Data Review Plan, review Summary Reports, CSR review – appendices and approval, oversight of safety report distribution to investigators, study team and ECs as applicable. Participate in SAE reconciliation
7. Initiation and Site Start Up - Prepare and review material for investigator meetingand CRA Training, conduct CRA training, plan / organize / conduct Investigator meeting, oversight of country regulatory approvals (e.g. CTA, MoH), oversee country / site IRB / EC approval, , oversee and/or prepare, review regulatory package (essential documents - blank forms and templates for 1572s, financial disclosure, etc.), review regulatory packages, develop and coordinate materials for investigator meeting, obtain appropriate country/site insurance, authorize investigational product shipment to investigational sites, including (in association with Regulatory)the initial shipment, review and approve informed consent forms (e.g. site or country specific ICFs)
1. Enrollment and Maintenance of Subjects - Ensure enrollment is tracked and recorded appropriately, compile enrollment status, update recruitment strategy, address enrollment and retention issues
2. Follow-Up of Sites, Subjects and Data- Oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced), oversee review and approval of monitoring trip reports, review data as defined by Study Team, schedule and conduct CRA meetings / teleconferences, follow up on outstanding CRFs and DCFs, perform ongoing resolution of subject eligibility, oversee resolution of study conduct issues, address site issues found during audits, support DMC reviews, ensure TMF is current
3. Close Out - Coordinate study close out, coordinate case book preparation, reconcile payments, reconcile study budget, complete all archiving, reconcile TMF
4. Line Management –May be responsible for overall performance management of direct reports, including:

8. Oversee personnel and assure adherence to GCP/ ICH and SOPs/WPs
9. Lead the performance review process for direct reports.
10. Identify and address performance issues and training needs.
11. Provide guidance regarding company policies and procedures.


Skills/Knowledge Required:

- Disease / therapeutic knowledge
- Excellent oral / written / presentation – solid communications skills
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Leadership skills (get it done) / negotiation skills
- Mentoring / coaching
- Time management - ability to effectively multi-task and prioritize
- Financial budgeting and forecasting skills
- Project management / organizational skills
- Solid computer skills – requirement of MS applications including (but not limited to) MS Project, Word, Excel
- Study Tools including electronic system skills – CTMS / EDC
- Knowledge of drug development process
- Cross functional and cross-cultural awareness
- Ability to work in a matrix environment
- Interpersonal skills

Key Competencies:

- Manages execution
- Commitment to quality
- Thinks strategically
- Uses sound judgment
- Drive for results
- Planning
- Fosters open communication
- Acts with integrity
- Fosters team work
- Analysis of issues

Recognizes global implications

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Study-Manager-Job-NJ-07901/1703044/170304417030442012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSSummit, NJ, USJob Title: Sr. Study Manager
Job ID: 12803
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Clinical Operations - 3603


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Minimum 6 clinical study management experience plus 2 years direct global study management experience
- BA / BS
- 9+ years pharma industry related experience

- Disease / therapeutic knowledge
- Excellent oral / written / presentation – communications skills
- Knowledge of GCP / ICH / FDA regulations and EU directive
- Leadership skills (get it done) / negotiation skills
- Mentoring / coaching
- Time management - ability to effectively multi-task and prioritize
- Financial budgeting and forecasting skills
- Project management / organizational skills
- Solid computer skills – requirement of MS applications including (but not limited to) MS Project, Word, Excel
- Study Tools including electronic system skills – CTMS / EDC
- Knowledge of drug development process (North America and global)

Summary/Scope: Leads cross functional study team to deliver clinical research studies on time, within budget and with good quality

Responsibilities will include, but are not limited to, the following:

1. Study Team Leadership- Lead cross-functional study team, develop, manage and maintain study timelines, minutes, budget and tracking, develop training materials and train team on study procedures, develop study management plan - study specific working practices, develop, manage, and maintain relationships with affiliate offices, develop study execution plans, provide mentoring and training
2. Study Planning - Review and comment on synopsis and protocol and CRFs, develop overall study budgets, approve number of investigative sites, train study team in protocol, develop investigational product supply forecasting / management, input on project specifications and feedback on requirements for CTMS, guide structure and oversee set up TMF
3. Selection and Evaluation of Investigative Sites - Participate in country selection, in collaboration with physician and CRS identify prospective investigative sites, review feasibility, participate in final investigative sites selection, develop and monitor investigative site budgets and negotiate financial terms of individual site budgets, manage site payments, monitor GCP/ICH site level compliance
4. Identification and Selection of Vendors - Participate in preparation of RFP, assumptions and SOW,recommend vendors, contribute and review specs for vendors (IVRS, Labs), manage study vendors, review and approve vendor invoices
5. Preparation of Study Documentation - Review essential regulatory documents, prepare detailed study timeline, develop and oversee risk management plan (e.g. for poor enrollment), prepare, review and approve Monitoring Plan, assure adherence to Monitoring Plan, review CRF design (paper), review eCRF specs (EDC) and review of CRF completion guidelines, design, review and approve study tools (for investigative site use), create study team contact roles and responsibilities, review DM documents (CRO and in-house studies), facilitate Development and Review of Data Review Plan
6. Input Clinical Database, Safety and CSR Reports - Review edit specifications (paper and EDC), participate in creation of user management tool (UMT), execute EDC User Acceptance Testing (UAT) scripts, review Summary Reports, CSR review – appendices and approval, oversight of IND safety report distribution to investigators and study team
7. Initiation and Site Start Up - Prepare and review material for investigator meetingand CRA Training, conduct CRA training, plan / organize / conduct Investigator meeting, oversight of country regulatory approvals (e.g. CTA, MoH), obtain country / site IRB / ethics committee approval, address issues from IRB discussion, prepare / review regulatory package (essential documents - blank forms and templates for 1572s, financial disclosure, etc.), prepare study binder for investigator meeting, obtain appropriate country/site insurance, authorize investigational product shipment to investigational sites, including (in association with Regulatory)the initial shipment, review and approve site-specific informed consent forms
8. Enrollment and Maintenance of Subjects - Ensure enrollment is tracked and recorded appropriately, compile enrollment status, update recruitment strategy, address enrollment and retention issues, verify milestones for investigative site payments
9. Follow-Up of Site and Subjects- Oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced), review and approve monitoring trip reports, resolve issues with clinical team from patient medical management, review data as needed, schedule and conduct CRA meetings / teleconferences, identify that additional CRFs/eCRFs are required, review additional CRFs/eCRF specs, follow up on outstanding queries, review CRFs, follows up on outstanding CRFs and DCFs, perform ongoing resolution of subject eligibility, resolve study conduct issues, address site issues found during audits, support DMC reviews, ensure TMF is current
10. Close Out - Coordinate study close out, case book review, reconcile payments, reconcile study budget, complete all archiving, reconcile TMF

Key (PDI) Competencies:

- Planning
- Manages execution
- Fosters open communication
- Fosters team work
- Drive for results
- Commitment to quality
- Demonstrates adaptability
- Leverages networks
- Uses technical functional implications
- Recognizes global implications
- Acts with integrity
- Thinks strategically
- Develops oneself
- Uses financial and quantitative data

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Sr_-Study-Manager-Job-NJ-07901/1705184/170518417051842012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSSummit, NJ, USJob Title: Legal Contracts Specialist
Job ID: 12812
Location: Summit, NJ
Offsite Territory: Category:

Legal
Department: Legal - 4104


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BA/BS degree in a related field or equivalent work experience; Paralegal certificate preferred. Minimum 3 years contracting experience in a legal department (in company or law firm); contract coordination experience preferred. In depth understanding of contract terms and conditions.

Summary/Scope:

Under the direction of Sr. Manager, Contracts, this individual will be responsible for facilitating the drafting and negotiation of agreements. As requested by internal clients, template agreements will be generated and the negotiation of non-template agreements for attorney review will be coordinated. Agreements include, but are not limited to, Confidentiality Agreements, Consulting Agreements, Service Agreements, Master Service Agreements, and Material Transfer Agreements. This individual will manage the contract process and work flow from requisition through execution of the agreement. A high volume of contracts requires the ability to meet deadlines. Must have strong interpersonal skills, be a team player, and be willing to work in an environment where individual initiative and accountability to the team are required. Must be able to work with limited day-to-day supervision; increasing independence over time.

Responsibilities will include, but are not limited to, the following:

- Facilitates the negotiation of agreements, terms and conditions
- Drafts documents following company templates
- Manages contract process and workflow (requisition through execution)
- Maintains contracts files and database
- Works with functional members to solve problems
- Communicates and interacts with internal clients
- Manages day-to-day activities
- Manages priorities/urgent requests
- Participates/makes suggestions in line function meetings


Skills/Knowledge Required:

- BA/BS degree in a related field or equivalent work experience; Paralegal certificate preferred
- Minimum 3 years contracting experience in a legal department (in company or law firm); contract coordination experience preferred
- In depth understanding of contract terms and conditions
- Computer skills (MS Office – Word, Excel, PowerPoint, Outlook)
- Excellent oral and written communication skills
- Proven ability to multi-task
- Ability to manage personal timelines and priorities with minimal supervision
- Ability to build relationships and influence others
- Ability to identify potential issues and problems
- Attention to detail/analytical thinking

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Coordinator%2C-Legal-Contracts-Job-NJ-07901/1716660/171666017166602012-06-14Celgene CorporationLegalfull-timeUSDstarting0BSSummit, NJ, USJob Title: Sr Manager, Stability
Job ID: 12815
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Research
Department: Stability - 1108


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BS or MS in analytical science or a related pharmaceutical field. Ten + years experience in Quality Control or in a Stability function within a Pharmaceutical company. Five+years experience in organizing Drug Stability functions and evaluating Drug Stability data

Responsibilities include, but are not limited to, the following:

1. Manage Celgene Stability Program: Directly supervise the Stability Specialists and other individuals responsible for the organization, maintenance, operation, and data evaluation required for the Drug Stability Program which is utilized for the evaluation of the stability of Celgene’s Developmental and Commercial Pharmaceutical Drug Products. Oversees the stability evaluation program for all development, clinical and commercial products at the Summit site according to ICH/FDA guidelines and approved submissions / commitments. Responsible for the tracking and trending of stability data. Interacts with the QC and R&D laboratories as well as Quality Assurance, Technical Operations, Global Regulatory CMC functions and contract service providers. Identifies capabilities and allocates resources to deliver stability study data and reports to meet current and future business and regulatory filing needs.
2. Compliance Systems:Develops, implements and maintains the activities of the Stability group in compliance with cGMPs, SOPs, good documentation practices and safety standards in accordance with corporate, regulatory and timeline expectations. Ensures that investigations are conducted in accordance with corporate, regulatory and timeline expectations.
3. Manage Projects and Implementation:Directs and manages stability studies, workflow, process and timeline plans to align with corporate, manufacturing, development and regulatory activities and priorities as related to the stability function. Facilitates teamwork and develops and coordinates execution of plans with key stakeholders. Allocates resources and ensures tracking and follow-up as necessary. Develops quality performance metrics to guide resource allocation, productivity of operations and continuous improvement. Budgets and monitors operating expenses for the Stability function.
4. Vendor Contacts:Communicates with outsourced analytical service providers responsible for stability testing of Celgene products and APIs.
5. Human Resources:Diagnoses and defines work team needs for effective performance. Assists in the recruiting of qualified employees. Develops internal talent through coaching, counseling, training and otherrelevant experiences that meet the needs of the organization. Sets performance objectives and regularly evaluates employee performance to ensure they are meeting both current and future needs.
6. Communications:Maintains productive communications with staff, internal colleagues in quality control, quality assurance, R&D, technical operations, development and regulatory affairs as needed to properly maintain the Stability Evaluation Operation and the timely delivery of customer-oriented data and documentation. Regularly exchanges ideas and information with key stakeholders to develop effective plans and strategies to meet business needs.


Skills/Knowledge Required:

- BS/MS in Analytical Chemistry or relevant scientific discipline
- 10+ years experience within QC function in pharmaceutical industry
- 5+ years experience within a Stability function in pharmaceutical industry
- Knowledge in the statistical evaluation of analytical data
- Thorough knowledge of cGMP in the pharmaceutical industry
- Strong knowledge and experience with use of a LIMS system in Stability
- Excellent problem-solving, verbal and written communication skills
- Must have strong interpersonal and communication skills, be a team player
- Must be an individual with proven initiative and demonstrated accountability
- Professional integrity and maturity are required
- Good computer skills and working knowledge of common business software

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Sr-Manager%2C-Stability-Job-NJ-07901/1722319/172231917223192012-06-14Celgene CorporationResearchfull-timeUSDstarting0BSSummit, NJ, US
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Apply Without Selecting Job]]>http://jobs.celgene.com/job/Berkeley-Heights-Associate-Director%2C-Regulatory-Affairs-Job-NJ-07922/1722322/172232217223222012-06-14Celgene Corporationfull-timeUSDstarting0BSBerkeley Heights, NJ, USLegal
Neuchatel, Switzerland

PREREQUISITES

Qualification: Law Degree or Equivalent Legal Qualification

Experience: Minimum 7 years PQE in the Life Sciences Industry

The Senior Legal Specialist will work as an integral member of the Legal Department, based in Boudry, Switzerland, reporting into the Vice President Legal Counsel. The Senior Legal Specialist will work closely with the Lawyers and sustain a client facing role retaining accountability for assigned clients. In particular the Senior Legal Specialist will have a proven track record in the following areas: clinical trials, observational studies, commercial contracts, corporate governance, developing working processes and SOPS. The Senior Legal Specialist shall also be assigned to specific ad-hoc projects plus tracking and advising on new legislation / regulations that relate to the assigned projects / workload.

Responsibilities include, but are not limited to:

- Fully conversant with clinical trial agreements and ancillary agreements, and able to review and draft same, irrespective of whether they are Company’s own or site specific templates. Further, able to identify key issues in contracting process that may impact other departments e.g. clinical / drug safety, and escalate same.
- Lead projects for clinical and observational studies, with minimal supervision, being the first point of contact with internal clients /outside counsel / CROs, able to work autonomously with reviewing / drafting / revising clinical and/or medical agreements. Additionally be assertive in role and able to challenge advice provided from CRO, obtaining legal clarification on contracting issues that may arise during course of studies and providing feedback to the internal clients and legal team. Able to escalate any issues that require intervention from the team Lawyer assigned to the respective geography/study working with same to bring to conclusion.
- Conversant with commercial agreements, irrespective of whether based on Company’s own templates or third party standard form agreements, and able to independently review and draft same for internal clients. Further, identify gaps where new templates are required and work directly with internal clients to understand their needs and accordingly draft templates required, e.g. recruitment agreements, power of attorneys, etc.
- Review and draft SOPs for assigned projects.
- Review and maintain standard form templates used by the Legal Contracts team.
- Proven track record in corporate governance, able to review current procedures and practices, establish working processes and tools, and provide guidance to the Legal Specialists.
- Stay Manage incoming internal client requests for ad-hoc contracts and/or projects.
- Appropriately referring high level legal issues to lawyers in the Legal Department for review and follow matter through to resolution.
- Able to prepare and deliver presentations to internal clients in support of special projects.
- Ensuring compliance with policies and procedures, ethical practices, company values, and adherence to relevant laws and regulations.

Skills/Knowledge Required:

- Law degree or equivalent.
- Minimum 5 years PQE in the Life Sciences sector, either in a law firm or in-house legal dept of an international company
- Proven track record in managing clinical and medical contracts and templates.
- Proven track record in reviewing and drafting commercial contracts and templates.
- Good knowledge of corporate governance procedures and practices.
- Self starter who is able to work autonomously in a client facing role and manage own work load / projects.]]>http://jobs.celgene.com/job/Neuchatel-Senior-Legal-Specialist-Job/1729003/172900317290032012-06-14Celgene CorporationLegalfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Maintenance Mechanic - Rotating 1st Shift (1 of 5)
Job ID: 12833
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Plant Maintenance - 1114


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a High School Diploma or equivalent with a minimum of 2 years related experience in a regulated setting, preferably in a manufacturing environment.
- Must have a working knowledge of power transfer technology including mechanics, pneumatics and hydraulics.
- Must be familiar with machine controls including Programmable Logic Controllers, relay logic, and operator interfaces.
- Must be familiar with plant utility systems including high pressure steam, heating, ventilating and air conditioning.
- Must be familiar with metal working including machining and welding.
- Must have a clear understanding of analytical troubleshooting.

POSITION SUMMARY

The Maintenance Mechanic supports all maintenance efforts including repairs, troubleshooting, and new installations in a compliant, efficient, and effective manner. This is a rotating 1st shift position. The hours are from 5:30am-5:30pm.

ESSENTIAL FUNCTIONS

- Responsible for maintaining all manufacturing equipment including formulation, filling and packaging equipment, and plant utility systems including, steam boilers, air compressors, heating, ventilating and air conditioning systems (HVAC), water for injection and general upkeep of the physical plant including clean rooms and building roofing.
- Responsible for implementing improvements to improve efficiency and prevent equipment obsolescence. Included are capital improvement projects like installing heating, ventilating and air conditioning systems, upgrading the water for injection system, rebuilding/upgrading filling and packaging equipment, and installing and start-up of new manufacturing and support equipment.
- Responsible for insuring the validated state of all equipment systems and facilities and compliance with all applicable cGMP, OSHA, DEC, EPA and local government regulations.
- Responsible for developing relationships with key vendors for technical support and for assistance in hardware applications.
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Maintenance-Mechanic-Rotating-1st-Shift-Job-AZ-85001/1731671/173167117316712012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Maintenance Mechanic - 2nd Shift (5 of 5)
Job ID: 12838
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Plant Maintenance - 1114


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a High School Diploma or equivalent with a minimum of 2 years related experience in a regulated setting, preferably in a manufacturing environment.
- Must have a working knowledge of power transfer technology including mechanics, pneumatics and hydraulics.
- Must be familiar with machine controls including Programmable Logic Controllers, relay logic, and operator interfaces.
- Must be familiar with plant utility systems including high pressure steam, heating, ventilating and air conditioning.
- Must be familiar with metal working including machining and welding.
- Must have a clear understanding of analytical troubleshooting.

POSITION SUMMARY

The Maintenance Mechanic supports all maintenance efforts including repairs, troubleshooting, and new installations in a compliant, efficient, and effective manner. This is a 2nd shift position for the first 6 to 12 months and the hours are from 3pm-12am. It will then transition into a 3rd shift position and the hours will be from 11:30pm-8am.

ESSENTIAL FUNCTIONS

- Responsible for maintaining all manufacturing equipment including formulation, filling and packaging equipment, and plant utility systems including, steam boilers, air compressors, heating, ventilating and air conditioning systems (HVAC), water for injection and general upkeep of the physical plant including clean rooms and building roofing.
- Responsible for implementing improvements to improve efficiency and prevent equipment obsolescence. Included are capital improvement projects like installing heating, ventilating and air conditioning systems, upgrading the water for injection system, rebuilding/upgrading filling and packaging equipment, and installing and start-up of new manufacturing and support equipment.
- Responsible for insuring the validated state of all equipment systems and facilities and compliance with all applicable cGMP, OSHA, DEC, EPA and local government regulations.
- Responsible for developing relationships with key vendors for technical support and for assistance in hardware applications.
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Maintenance-Mechanic-1st-Shift-Job-AZ-85001/1731672/173167217316722012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Clinical Research Scientist - Inflammation & Immunology
Job ID: 12839
Location: Warren Township, NJ - 33
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Inflammation - 3608


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

Degree in Life Sciences (e.g. BS in Nursing, Pharmacy or related medical field), minimum 4 - 7 years experience in Clinical Research Development or equivalent.

The Clinical Research Scientist, Inflammation & Immunology is responsible for contributing scientific insight and expertise in clinical trial design, statistics, pharmacodynamics and pharmacokinetics to support ongoing clinical research projects. Interface with project team members including Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management, in order to develop and implement regulatory strategies and preparation of material for regulatory authorities and management.

- Prepare key documents for Investigator Brochures (“IB”), regulatory submission documents, internal/external presentations, and related documents to support clinical research and drug development for Inflammation & Immunology therapeutics.
- Prepare protocols and guidelines, including writing, reviewing, amending and cross-functional facilitation as appropriate, and collaborating with Key Opinion Leaders as required.
- Prepare and review clinical study reports in order to determine potential drug indicators and clinical development plans.
- Prepare summary documents based on review of scientific literature for inclusion in IB, protocols, and regulatory submission documents.
- Plan and develop assigned compounds and assisting with development of CDPs. Oversee and challenge the adequacy of planning for study implementation.
- Collaborate with the project physician to direct the planning and implementation of clinical programs to meet corporate and clinical research goals.
- Provide clinical research expertise in the guidance and recommendations to Clinical Research Physicians in the management of ongoing projects.
- Prioritize project/study timelines to ensure adequate staffing for data management, drug supply, clinical operations, and drug safety.
- Collaborate and support operational objectives as needed. Assist in establishing project budgets and Standard Operating Procedures, and reviewing ongoing study data including: safety, primary efficacy variables, and laboratory data.
- Plan, participate and present at investigator meetings and ad-hoc meetings.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Warren-Township-Clinical-Research-Scientist-Inflammation-&-Immunology-Job-NJ/1731673/173167317316732012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSWarren Township, NJ, USJob Title: Maintenance Mechanic - Rotating 2nd Shift (3 of 5)
Job ID: 12835
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Plant Maintenance - 1114


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a High School Diploma or equivalent with a minimum of 2 years related experience in a regulated setting, preferably in a manufacturing environment.
- Must have a working knowledge of power transfer technology including mechanics, pneumatics and hydraulics.
- Must be familiar with machine controls including Programmable Logic Controllers, relay logic, and operator interfaces.
- Must be familiar with plant utility systems including high pressure steam, heating, ventilating and air conditioning.
- Must be familiar with metal working including machining and welding.
- Must have a clear understanding of analytical troubleshooting.

POSITION SUMMARY

The Maintenance Mechanic supports all maintenance efforts including repairs, troubleshooting, and new installations in a compliant, efficient, and effective manner. This is a rotating 2nd shift position. The hours are from 5:30pm-5:30am.

ESSENTIAL FUNCTIONS

- Responsible for maintaining all manufacturing equipment including formulation, filling and packaging equipment, and plant utility systems including, steam boilers, air compressors, heating, ventilating and air conditioning systems (HVAC), water for injection and general upkeep of the physical plant including clean rooms and building roofing.
- Responsible for implementing improvements to improve efficiency and prevent equipment obsolescence. Included are capital improvement projects like installing heating, ventilating and air conditioning systems, upgrading the water for injection system, rebuilding/upgrading filling and packaging equipment, and installing and start-up of new manufacturing and support equipment.
- Responsible for insuring the validated state of all equipment systems and facilities and compliance with all applicable cGMP, OSHA, DEC, EPA and local government regulations.
- Responsible for developing relationships with key vendors for technical support and for assistance in hardware applications.
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Maintenance-Mechanic-Rotating-2nd-Shift-Job-AZ-85001/1731674/173167417316742012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Sr Analyst, IT Global Delivery Services, Business Intelligence
Job ID: 12847
Location: Basking Ridge, NJ -106
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: IT - Applications - 4162


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Bachelor’s degree required.

The Senior System Analyst - Business Intelligence plays a key role in the architecture and administration of Business Objects and additional bolt on tools. This includes administration of the Business Objects servers, EQM server, and Universe design support. In addition, providing the architecture of proposed business intelligence solutions is required. The Senior System Analyst must excel at working in a collaborative, diverse, complex, resource-constrained environment and be able to support decision-making processes that involve multiple constituencies and constraints. He or she will be expected to continuously improve systems and processes that fall within the range of their responsibilities.


Responsibilities will include, but are not limited to the following:

- Administer and maintain Business Objects XI 3.1 on Development, Test, Validation and Production environments.
- Level 2 support for Business Objects and EQM
- Maintain and assist developers for Business Objects XI 3.1 Universes, WEBI and DeskI reports.
- Administer security settings using Central Management Console on XI 3.1.
- Liaise with the vendor for upgrades and issues.
- Plan and test patches and new releases for XI 3.1 environments.
- Support the Migration of reports and Universes from Development to Test and Validation and Production environments, using the EQM(Noad) toolset.
- Developing effective standards, best practices, procedures and key metrics to enhance operational stability of the Business Objects environments.
- Assist in the solution architecture design for various BI initiatives
- Stay current on new industry based technical trends and application opportunities.


Skills/Knowledge Required:

- 5+ years of experience working within Business Intelligence solutions.
- Experience with the entire Business Objects XI R2 & R3 Application Suite.
- Experience with dimensional, logical and physical data modeling for data warehouse/data marts.
- Minimum of 3 years experience in developing Business Objects reports, universes, VBA scripting, SQL, HTML in XI 3.1
- Working knowledge of Windows and UNIX operating systems.
- Working knowledge of Oracle databases
- Ability to effectively communicate information, both verbally and written, to developers, end users and management
- Ability to comprehend complex technical and logical concepts and adapt quickly to changes.
- Ability to maintain own workflow and meet deadlines.
- Ability to prioritize tasks to best meet departmental and organizational goals.
- Excellent troubleshooting skills.
- Ability to respond to frequent demands of multiple internal customers.
- Strong communication and interpersonal skills.
- Analytical, problem solving and quantitative skills.
- Ability to work cooperatively and effectively as part of a team
- Must be client service-driven with excellent relationship management and analytical skills.
- Flexible, adaptable and hands-on approach necessary.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Basking-Ridge-Sr-Analyst%2C-IT-Global-Delivery-Services%2C-Business-Intelligence-Job-NJ-07920/1733306/173330617333062012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBasking Ridge, NJ, USJob Title: Senior Director, External Manufacturing
Job ID: 12852
Location: Basking Ridge, NJ -110
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Manufacturing - 1101


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Life Sciences or Engineering degree; advanced degree (MBA) preferred.
15+ years related experience in the pharmaceutical industry.
10+ years related experience in cGMP/FDA regulated manufacturing facility.
.

The Sr. Director, External Manufacturing plays a key leadership role in Technical Operations with responsibility and accountability for the oversight of the manufacturing of Celgene commercial products via multiple global third party manufacturing facilities. This position ensures consistency in managing these external relationships. The primary function of this position will be to oversee the startup and ongoing performance of multiple international contract manufacturing factories for both existing and new technologies and products. The incumbent will be responsible for implementation of strategic initiatives at factory locations to best meet Celgene’s requirements for quality, compliance, technology, delivery and cost. This position will work closely across both factory and corporate functions to integrate the corporation’s policy, process and technology for best results.

Responsibilities will include, but are not limited to, the following:

- Oversees team who serve as the primary relationship managers with multiple international contract manufacturing factories. Provide primary point of contact for day-to-day decision making and elevation/resolution of issues from both Celgene and external organizations.
- Direct the activities of multiple international contract manufacturing factories in order to produce the required semi-finished or finished products.
- Create the strategy and develop policies across a matrix organization to ensure factory problems and questions are resolved quickly and root cause corrective actions are implemented and standardized.
- Accountable for all aspects of performance for assigned factories with the primary focus being the delivery of quality product, on-time at a reasonable cost.
- Ensure global processes, procedures and standards are implemented at assigned factory facilities and oversees audits designed to verify compliance.
- Aid in the negotiation of supplier contracts and agreements, including development of key commercial terms, performance indicators and compliance requirements.
- Ensure Celgene and contract manufacturing factories are working in compliance with approved contracts and agreements.
- Prepare and implement long-term capacity, risk management and performance improvement plans for assigned factories.
- Oversight, management and approval authority over annual cost of goods budgets and related factory expenses. Annual spend will be in the range of $10 - $100 million.
- Work with global planning and sourcing groups to implement our short, mid, and long-term production strategies.
- Oversees team who ensure the materials and components required by each factory are sourced from approved suppliers and meet the applicable quality and compliance requirements.
- Oversees team who establishes and maintains adequate safety stocks of materials, components and semi-finished product as required.
- Approve work orders and purchase orders for assigned factories. Review and approve invoices/payments.
- Lead the evaluation, planning and implementation of process/product changes within the factory and maintain compliance with global regulatory filings and approvals.
- Provide operational, financial and decision support analysis to senior Technical Operations management.
- Provide senior management with timely, reliable and well structured information regarding factory performance including tracking of KPI’s, variance analysis and contingency plans for corrective measures.
- Participate in the Sales and Operations Planning (S&OP) process and implement any related initiatives.
- Ensure ERP (Oracle) system data for assigned factories and assure related system transactions are completed in a timely manner.
- Ownership and understanding of assigned products, processes and technologies.
- Oversee technology transfer projects and activities at assigned factories.
- Participate in product development or commercial launch teams for specific products
- For each assigned factory, ensure compliance with environmental, health and safety requirements related to the manufacturing, packaging or distribution of assigned products
- Develop the business and financial objectives for major supply chain projects and evaluate alternative solutions as basis for senior management decision.
- Ensure performance scorecards are in place to ensure the consistent implementation of KPI’s with 3rd party contracts.

The incumbent will also be responsible for working with Celgene senior and executive management for the development of:

- Long term strategic plans and annual budgets to meet the ongoing needs of supply chain operations.
- Policies, procedures and systems to assure appropriate operational control and risk mitigation across entire supply chain.
- Plans and actions to assure the necessary steps are taken to prepare the Celgene supply chain to support new product launches, product in-license operations, new market and trading partner opportunities, and other supply chain related activities.
- Responsible for coordinating with internal manufacturing operations to ensure consistent performance across internal and external manufacturing and overall compliance to Celgene policies and quality systems.


Skills/Knowledge Required:

- Hands on knowledge and technical understanding of assigned products, processes and technologies.
- Hands on experience in manufacturing or packaging of pharmaceutical products.
- Understanding of pharmaceutical manufacturing related key performance indicators (KPI’s) and operational metrics.
- Knowledge and experience in cost of goods management and corresponding financial impact of business decisions.
- Demonstrated ability to oversee a complex project which incorporates the use of tools such as Gantt charts, critical path analysis, risk mitigation strategies and project management software. Understands how these tools are used and directs team in their proper use.
- Global operations experience, import / export operations, working knowledge of regulatory, drug licensing, and operating requirements in a global market.
- Must possess highly developed project management, communication and analytical problem solving skills
- Experience with the development and validation of manufacturing/packaging processes or analytical methods
- Excellent written and oral communication skills in a global environment
- Enterprise Resource Planning (ERP, Oracle) system experience and understanding of purchasing, planning, scheduling, inventory management and manufacturing information and related transactions.
- Demonstrated experience in establishing and maintaining supplier/contractor relationships.
- Demonstrated experience in managing external manufacturing or packaging operations.
- Working knowledge of international GMP requirements and quality systems
- Ability to raise levels of performance by establishing an improvement process, or setting specific, measurable targets and goals linked to business needs.
- Demonstrated leadership skills and ability to develop effective working relationships with internal/external partners and cross-functional project teams.
- Proven ability to make independent and objective decisions and to work with minimal direct supervision.
- Strong team player with high level of integrity, energy and enthusiasm.
- Willing to travel 25% domestically and internationally often on short notice.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120321
]]>http://jobs.celgene.com/job/Basking-Ridge-Sr-Director%2C-External-Manufacturing-Job-NJ-07920/1737145/173714517371452012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSBasking Ridge, NJ, USJob Title: Bilingual Inside Sales
Job ID: 12854
Location: Cedar Knolls, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Sales - CCT
Department: Inside Sales - 2506


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BA or BS degree and 1-2 years successful inside sales experience

Responsibilities will include, but are not limited to, the following:

1. Answer questions regarding and selling cord blood banking and LifebankUSA

2. Meet and/or exceed established sales quotas.

3. Produce high quality work that meets established quality goals.

4. Provide prospects with the benefits of LifebankUSA and persuading them to enroll in the LifebankUSA program.

5. Assist clients with the completion of enrollment forms. Review submitted forms for accuracy and completeness.

6. Conduct follow-up with clients to set expectations, obtain additional information, and provide for an exceptional client experience.

7. Adhere to federal, state, company and accrediting agency guidelines and requirements for documentation.

8. Using internal database system to keep track of every call, following up on leads, placing outgoing calls to potential clients who have called but have not yet enrolled.

9. Other duties will include various projects, such as, but not limited to, internet research and competitive analysis.

10. Team rotation for on-call responsibilities for client emergencies that may take place during holidays and off hours.

Hours

Must be able to work flexible hours up to 8:00pm.

Saturday: (required approx. once every 6 weeks). Occasional holiday required.


Skills/Knowledge Required:

- Exceptional client advocacy, time management, negotiation, relationship building, and interpersonal skills
- Excellent written and oral communication skills
- Experience with Salesforce.com a plus
- Strong negotiation skills and the ability to multi-task and thrive in a fast paced environment
- Strong PC/data entry skills

Written and spoken fluency in Spanish required

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120228
]]>http://jobs.celgene.com/job/Cedar-Knolls-Client-Education-Specialist-Job-NJ-07927/1739767/173976717397672012-06-14Celgene CorporationSales - CCTfull-timeUSDstarting0BSCedar Knolls, NJ, USJob Title: Clinical Research Physician
Job ID: 12859
Location: Warren Township, NJ - 33
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Inflammation - 3608


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Minimum M.D. degree and substantial medical/clinical training in Therapeutic Area or a related field.
- Minimum 5years of experience designing, leading and managing significant clinical trials in the Therapeutic Area
- Direct industry experience is preferred; substantial experience working on industry-sponsored trials will be considered.

The Role/Responsibilities:

The Clinical Development Leader, Therapeutic Area will be instrumental in supporting the growth of the Company's Therapeutic Area infrastructure as the organization continues to build the value of the current products and develop new products. The incumbent will have hands-on responsibility leading the clinical development team, designing and executing clinical trials, and running programs focused on Therapeutic Area, and will exhibit a passion for Phases 1 through 3, including biomarkers, proof-of-concept and full development. This position offers potential growth opportunities to the right candidate possessing a combination of intellectual and execution skills and a love of the science. Representative responsibilities will include:

- Define Target Product Profile and endpoints.
- Plan the overall clinical development of new drug candidates.
- Design and optimize clinical trial and ensure clinical trials meet ethical and regulatory standards.
- Lead the Clinical Development Team, including interactions with discovery, safety, marketing, regulatory, research and other functions.
- Conduct medical review and interpretation of efficacy and safety data from clinical trials.
- Have responsibility for the quality, coordination, medical accuracy and timeliness of clinical study reports.
- Work with Therapeutic Area Head and other team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
- Assist senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, and clinical expert reports.
- Present and discuss data and findings at relevant team, governance, KOL and regulatory meetings.
- Participate as clinical representative on multidisciplinaryProject Teams.
- Establish and maintain working relationships with study investigators, key opinion leaders, academicians, and Celgene senior managers and department heads across the corporation
- Ensure adherence to GCP/ICH and Celgene Standard Operating Procedure (SOP) standards.
- Maintain clinical and scientific awareness in area of expertise
- Guide day to day work of Clinical Research Scientists.
- Manage lifecycle requirements and plans for designated indications.

Key requirements / knowledge

- Understanding of drug development process.
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
- Experience in designing Clinical trial strategies to obtain regulatory approval.
- Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product.
- Ability to develop and evaluate strategies for the clinical development of a designated indication and to critically evaluate outside expert advice.
- Experience in Clinical project planning.
- Experience working on global and complex Clinical trials.
- Experience working effectively in a team/matrix environment.

Competencies / skills

- Strong scientific/technical skills
- Strong interpersonal capabilities and ability to build networks
- Proficiency in anticipating and resolving problems
- Excellent managerial and leadership skills
- Excellent verbal communication and technical writing skills
- Ability to present clearly using scientific and clinical terminology
- Ability to lead cross-functional teams and a true team player
- Possesses sense of urgency and can take initiative
- Project management skills and focus on delivery of results
- People management skills
- Ability to motivate

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Warren-Township-Clinical-Research-Physician-Job-NJ/1741978/174197817419782012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSWarren Township, NJ, USJob Title: Manager, Clinical Data Standards & Integration
Job ID: 12858
Location: Basking Ridge, NJ -110
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Clinical Data Ops Sys&Standard - 3612


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BA/BS in a relevant health science or computer science discipline; minimum experience: 5 – 7 years as a clinical programmer/data manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience

The primary focus of this position is to act as a Project Standards Manager within the Clinical Data Standards & Integration (CDSI) group, overseeing the activities associated with the consistent implementation of standards for Celgene studies within projects, including studies contracted to Contract Research Organizations (CROs).

Responsibilities will include, but are not limited to:

1. Operational Support for Implementation of Celgene Data Standards
- Develop and maintain data standards for one or more projects and for individual studies within the project(s), following Celgene global data standards. Make decisions in conjunction with senior CDSI staff regarding when project data standards can and should deviate from Celgene global data standards. Data standards will include, but not be limited to, the CDISC Study Data Tabulation Model (SDTM), Controlled Terminology, or other relevant, current industry standards models.
- Provide input into individual study deliverables with data standards components, including:
- CRF design, ensuring the same CRF standards (including metadata) are used for all studies in a project
- CRF Completion Guidelines to ensure consistency across studies within a project in how and when CRFs are completed
- Programmed edit checks to ensure consistency in data meaning across the studies within a project
- Data transfer specifications to ensure consistency across the project in external data structure to facilitate mapping to the SDTM standard
- Assist study Data Managers and Clinical Programmers with the validation of SDTM domains, including generation and review of output from software tools such as OpenCDISC. Coordinate feedback from the validation process to vendors who provide the SDTM domains
- Ensure availability of resources and development and enforcement of timelines for data transfers required for creation of SDTM domains, and for delivery and validation of SDTM outputs
- Communicate and reinforce content and interpretation of SDTM specifications to individual Study Data Managers, Statistical Programmers, Statisticians, and Clinical Programmers, including CRO staff, to ensure consistency in understanding and implementation of standards across a project
- Act as the key point of contact for project specific SDTM standards issues
- Participate in Clinical Team and Study Team meetings as needed, specifically in a supportive capacity

2. Standards Support for Submissions
- Develop overall project strategy related to data standards for regulatory filings, including how data are to be submitted, the format in which individual studies are to be submitted, and what version of the coding dictionaries are to be used.
- Determine which studies in a submission require coding upgrades for the purposes of data integration
- Work with the Submission Team to prepare pre-NDA correspondence on submission datasets
- Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements
- Develop plan and assure resources are available for timely provision of SDTM-related submission deliverables (e.g., SDTM annotated CRF, define.pdf and/or define.xml file, XPT files)
- Represent the CDSI group on project Submission Team(s)

3. Other Key Activities
- Author, review, and approve SOPs and Working Practices applicable to the Clinical Data Standards & Integration (CDSI) group or the Clinical Data Operations, Systems, and Standards (CDOSS) department
- Assist in developing job descriptions for department and managing more junior personnel, as required
- Conduct special projects as assigned
- Share best practices

Skills/Knowledge Required

- BA/BS in a relevant health science or computer science discipline; minimum experience: 5 – 7 years as a clinical programmer/data manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience. Medical or mathematics/computer science background a plus.
- Strong working knowledge of the Study Data Tabulation Model and the creation of data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml.
- Strong project management and negotiation skills
- Computer skills: knowledge of data structures within clinical data management systems, especially electronic data capture systems; understanding of SAS, including ability to use SAS System Viewer and to create basic SAS queries. Experience in programming databases is a plus.
- Experience in CRF design, query resolution, and data validation
- Good communication skills; ability to work in a team environment with medical personnel, clinical monitors, data managers, clinical programmers, statisticians, and statistical programmers
- Submission experience

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Basking-Ridge-Manager%2C-Clinical-Data-Standards-&-Integration-Job-NJ-07920/1741979/174197917419792012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSBasking Ridge, NJ, USJob Title: District Sales Manager, Hematology - Ohio Valley
Job ID: 12853
Location: OffSite
Offsite Territory: Cleveland, OH
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Sales
Department: Salesforce - 2502


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Bachelor’s degree in Business or Science; minimum of 5 years sales experience. Previous Management experience is a plus. Prior cross-functional and/or home office experience highly desirable.

This position will be responsible for leading a district to achieve all assigned goals and maintain compliance with Celgene’s Policies that govern field sales activity.

Responsibilities will also include, but are not limited to, the following:

1. Lead district sales force activities including: hiring, training, development, performance evaluation, and compliance to corporate policies.
2. Responsible for delivering assigned sales targets and aligning field activities to the strategic initiatives of the brand.
3. Partner with Sales Operations to affect the data input and analysis of physician and other customer profile information to ensure appropriate resources are deployed within the district.
4. Responsible for setting clear expectations and evaluating compliance to Celgene’s Regulatory Standards and Promotional Policies for all members in his/her district.
5. Ensure each employee is trained on and effectively implementing customer education to ensure Celgene’s Risk Map programs are successfully implemented.
6. Ensure the district is aware of the specific roles and responsibilities and appropriately utilizes the Patient Support Coordinators, Advocacy Development Managers, Clinical Nurse Specialists, Celgene Customer Care Center, Drug Safety, and Medical Services.
7. Responsible for allocating and managing district budget.
8. Build and sustain relationships with district Key Opinion Leaders.
9. Partner with National Account Manager, RAM, CNC, and PSS to develop appropriate business strategies that support the brand objectives.
10. Establish and develop cross-functional partnerships and leverage resources across the district to influence customer behavior.
11. Set clear expectations for utilization of approved promotional programs.
12. Communicate competitive market intelligence to brand teams and management.


Skills/Knowledge Required:

- BS in Business or Science; minimum of 5 years sales experience in the pharmaceutical/biotechnology industry with a preference for prior sales management and tenure within another functional area to include national accounts, training, medical affairs, marketing and government affairs.
- Strong leadership skills.
- Ability to manage a district’s vision and purpose that is consistent with corporate imperatives and revenue targets.
- Possess strong presentation, organization, administrative and communication skills.
- Project professional and polished impression.
- Model highest level of professional behavior and ethics and Celgene Values of Passion for the Patient, Courage to Face Challenges, Trust and Excellence in Execution.
- Familiar with trade relations, reimbursement environment, government programs, managed care, formulary and contract negotiation.
- Demonstrated understanding of oncology therapeutic area, products and marketplace.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120312
]]>http://jobs.celgene.com/job/Cleveland-District-Sales-Manager%2C-Hematology-Ohio-Valley-Job-OH-44101/1741980/174198017419802012-06-14Celgene CorporationSalesfull-timeUSDstarting0BSCleveland, OH, USJob Title: Senior Director, IT PMO
Job ID: 12862
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: IT - Program Management Office - 4166


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Reporting to the Executive Director, Global IT Delivery Services, the Leader of the IT PMO is responsible for the management of a portfolio of IT projects across the enterprise with functional reporting on projects originating in any of the Plan/Build/Run teams. As a senior IT leader, the incumbent is accountable for project and portfolio management standards and their application to project implementation activities across the various IT functions. Develops and implements project management methodologies and portfolio management tools to provide a governance structure for all IT project managers to manage their projects. Supports our business and delivers against stated objectives by ensuring project deliveries achieve high levels of quality, service and compliance. Champions and leads development and adherence to the IT project management lifecycle. The Leader, IT PMO is a member of the Global Delivery Services leadership team.


Responsibilities will include, but are not limited to the following:

▪ Leads the IT PMO delivering robust portfolio/project management. Responsible for ensuring services from third parties/key partners meet/exceed Celgene delivery requirements and standards.

▪ Establishes sound management processes and sets strategic direction for portfolio and financial management to efficiently and effectively deliver the portfolio of applications.

▪ Develops processes to improve project performance and identifies metrics for measuring performance, develops methods for effectively reporting on project performance, and utilizes those metrics for improvements and resource justification.

▪ As a member of the Global Delivery Services senior leadership team, leads and manages select global processes/programs to achieve business objectives. Works collaboratively to support and improve business performance and capabilities and to ensure we fully leverage business investments.

▪ Provides the portfolio management tools that provide up-to-date project status for implementations, upgrades, other maintenance activities, including schedules and financial forecasts.

▪ Assists the senior IT leadership team with resource management and recommends adjustments in projects and programs to meet project objectives and to yield greater efficiencies.

▪ Works with business and IT stakeholders to identify, communicate and resolve resource allocation, scope, schedule, and/or budget conflicts.

▪ Ensures issues are effectively articulated, communicated, and escalated to alleviate IT delivery or budget issues.

- Develops Key Performance Indicators (KPIs) and Metrics Packages for IT project delivery.

▪ Provides the cultural environment to develop, deliver and drive improvements in new capabilities, standards, and ways of working in the organization.

▪ Manages recruitment, retention, and development for IT PMO key talent located at all sites globally.

▪ Manages and operates within budget.

B.A. or B.S./M.S. in a relevant discipline. 20+ years of combined pharmaceutical and/or information technology industry experience. 10+ years of supervisory and project management experience.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Senior-Director%2C-IT-PMO-Job-NJ-07922/1741982/174198217419822012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Director, Customer Care (Call Center)
Job ID: 12861
Location: Warren Township, NJ - 7
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Customer & Product Support
Department: Customer Care - 2551


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BA or BS degree required; MBA or Masters in health administration or related field
strongly preferred

Under the direction the Senior Director, Head of Global Risk Management Operations, incumbent will be responsible for leading the efforts of the Celgene Customer Care Department. Provide leadership and motivate direct reports through results-oriented focus, clear communication and direction, delegation and active career development and coaching.

Responsibilities will include, but are not limited to, the following:

- Direct and lead all aspects of daily operations in the US Customer Care department
- Lead, motivate, and develop the Customer Care department by establishing priorities, providing clear direction, and actively coaching and developing direct reports
- Implement staffing plans (recruitment, compensation, performance monitoring, motivation, etc…) to ensure department meets corporate objectives
- Responsibility for creation, monitoring and maintenance of department budget.
- Ensure full compliance with FDA REMS requirements, by working closely with Medical and Regulatory Affairs departments.
- Serve as subject matter expert on topics pertaining to current and future FDA REMSs utilized by Celgene including S.T.E.P.S.®, RevAssist®
- Develop excellent internal relationships with Sales Operations, Commercial and Marketing to assist with REMS and customer care initiatives
- Develop excellent internal relationships with Technical Operations on distribution initiatives.
- Maintain an active role on key cross-functional projects (i.e. PRiME®) to ensure Customer Care needs are included in the research and plans
- Identify ethical, innovative and customer oriented strategies in response to changing corporate needs, and collaborate with peers and internal partners to develop solutions to Customer Care challenges
- Ensure departmental training is effective, efficient and meets all internal quality requirements
- Ensure adequate Customer Care training and coverage is provided, and performance metrics are met
- Implement monitoring tools to ensure department is operating at optimal levels, and providing excellent customer service. Continuously analyze data and implement tactical changes as required.
- Evaluate customer complaints and recommend process improvements as appropriate
- Ensure FDA REMS reports are produced on time
- Develop and deliver REMS presentations to internal and external groups as required
- Ensure disaster recovery and business continuity plans are appropriate, maintained, and tested on a regular basis
- Ensure department would pass all internal or external audits
- Assist in the definition of global risk management operations strategy


Skills/Knowledge Required:

The Director US Customer Care will work closely with the Senior Director, Head of Global Risk Management Operations. However, the ability to implement agreed operational activities relatively independently is critical. The role requires:

- At least 5 years experience in pharmaceutical or healthcare services
- Excellent management, leadership, presentation and communication skills
- Proven leader who has led a department, call center experience required.
- Good organizational savvy and ability to work well across functions and levels in the organization
- Ability to design, analyze and report performance metrics
- Proven success in organizational planning and implementation

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120306
]]>http://jobs.celgene.com/job/Warren-Township-Director%2C-Customer-Care-Job-NJ/1741983/174198317419832012-06-14Celgene CorporationCustomer & Product Supportfull-timeUSDstarting0BSWarren Township, NJ, USJob Title: Director, Regulatory Affairs
Job ID: 12867
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Regulatory
Department: Regulatory Affairs - 3691


About Celgene

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

- Completed Bachelor’s degree in a scientific discipline required (advanced degree preferred).
- Oncology experience highly preferred.
- Must have at least 10 years pharmaceutical industry experience in clinical regulatory affairs, inclusive of at least 7 years experience in a senior regulatory leadership role formulating strategy and driving decision-making.
- Must be able to travel overnight for business 15% or more, depending on project needs.
- Prior direct or matrixed employee management experience preferred.
- Established regulatory accomplishments in a different therapeutic area also desired.

Responsibilities will include, but are not limited to, the following:

1. Serve as Global Regulatory Strategy Leader for late stage marketed product with multiple indications. For each indication, will:
2. Develop and create strategy for long-term planning at a cross functional level for product, consistent with the corporate and project objectives.
3. Represent regulatory in senior management discussions and present issues accordingly.
4. Interface with international affiliates on regional regulatory strategy and implementation plans.
5. Provides strategic direction to Regional Regulatory Strategy Lead in preparing teams for project related interactions with Regulatory Agency(ies).
6. May engage with Regulatory Agency(ies) on project related interactions.
7. Provide innovative solutions to challenging opportunities.
8. Responsible for the development of global regulatory strategies, in collaboration with the Global Regulatory Team and Strategic Regulatory Intelligence and Policy, which are consistent with the global Project Team goals and objectives.
9. Accountable for ensuring the appropriate implementation of the global regulatory strategy.
10. Identify issues proactively (i.e. regulatory or competitive) that will impact programs and provide strategies to address them. Communicate these issues to the Global regulatory strategy leader, global regulatory sub-team and to functional management.
11. Provides insight and recommendations on health authority guidance in collaboration with the strategic liaison, policy, and regulatory intelligence group.
12. Conduct Business Development diligence efforts, if assigned.
13. Be a strategic partner and team player in the various decision-making committees within the company.
14. Manage up to at least 2 direct reports.
15. Engage with patient support services at Celgene to maximize regulatory and development strategies.

Minimum
Skills/Knowledge Required:

- Completed Bachelor’s degree in a scientific discipline required.
- Must have at least 10 years pharmaceutical industry experience in clinical regulatory affairs, inclusive of at least 7 years experience in a senior regulatory leadership role formulating strategy and driving decision-making.


Preferred Skills/Knowledge:

- Completed Master’s (or higher-level degree) in a biological sciences concentration is preferred.
- Oncology experience highly preferred.
- Prior direct or matrixed employee management experience preferred.
- Established regulatory accomplishments in a different therapeutic area also desired.


Equal Employment Opportunity

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Director%2C-Regulatory-Affairs-Job-NJ-07922/1744834/174483417448342012-06-14Celgene CorporationRegulatoryfull-timeUSDstarting0BSBerkeley Heights, NJ, USFacilities
Neuchatel, Switzerland

PREREQUISITES

Valid Swiss working permission or EU Citizenship required

Competences :

This position is responsible to manage engineering projects in regards to implementation of equipments and process systems in the pharmaceutical manufacturing buildings. You participate to conceptual design, basic design, specifications, construction, follow-up of installation, start-up and commissioning. Vous intervenez sur des projets concernant la mise en place d'équipements et de systèmes de production/ process des bâtiments de production pharmaceutique. Vous participez aux études APS (Avant-Projet Sommaire), APD (Avant-Projet Définitif), rédigez des cahiers des charges et suivez les phases d'études, de réalisation, d’installation et de mise en service.

Skills/Knowledge Required:

- li+ 6 years experience in a pharmaceutical company or other related industy. Vous avez de solides connaissances techniques et une expérience dans la réalisation de projets et la mise en place d'équipements de production de minimum 6 ans dans le secteur de la santé.
- Solid knowledge of GMP and FDA regulatory requirements.
- Solid technical knowledge and experience in project management.
- Solid knowledge in process technologies (solid dosage forms, packaging…)
- Solid knowledge in the validation of procedures and systems.
- Fluent in English and French.
- Excellent written and communication skills.
- Excellent organizational skills.
- Excellent team spirit.
- Rigueur, autonomie et organisation vous permettent de travailler efficacement en équipe avec l'ensemble de vos interlocuteurs. Bon relationnel.
- Ability to take decision.
- Knowledge of most common office software (MS Office, MS Project). Knowledge of Autocad is an asset.

Responsibilities include, but are not limited to:

- Development of design and functional specifications. Elaboration du cahier des charges.
- Selection and review of suppliers. Sélection et consultation des fournisseurs.
- Follow-up of studies: feasibility, design, PFD and PID preparation, equipments and utilities sizing. Suivi des études : conception, création de PFD et de PID, dimensionnement des équipements et utilités.
- Follow-up of project execution, equipments installation including commissioning, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT). Suivi de la réalisation des missions, de l'installation des machines à la mise en service, comprenant les tests d'acceptation usine (FAT) et d'acceptation sur site (SAT)
- Management of external companies working on site.
- Troubleshoot existing pharmaceutical equipment, coordinate equipment purchase and installation.
- Successfully interface with manufacturing team, maintenance team, project managers and engineering professionals.
- Prepare project plans for equipment improvements including schedules, budgetary estimates and capital spending requests.
- Manages investment projects, participate to the investment strategy and budget definitions.
- Coordinates different teams as Project Manager working on new projects.
- Participates to the selection of new contractors.]]>http://jobs.celgene.com/job/Neuchatel-Associate-Project-Manager%2C-Technical-Facilities-Job/1749890/174989017498902012-06-14Celgene CorporationFacilitiesfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Sr. Director, Global Safety MD (Approved Products)
Job ID: 12880
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Drug Safety
Department: Drug Safety - 4202


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

MD (or international equivalent) with a minimum of:

- Ten (10) years relevant clinical experience, including training
- Five (5) years pharmaceutical/biotechnology industry experience
- Four (4) years in safety role
- Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred (oncology)
- Thorough understanding of global regulatory requirements for pharmacovigilance
- Clinical knowledge of therapeutic area patient populations and drug classes in hematology/oncology

Summary/Scope:

- To support a single interpretation of global safety data for defined products
- Identifying and managing safety concerns with approved Celgene products
- Develop aggregate analyses and reports addressing approved product safety profiles.

Core Responsibilities:

Governance

Company Safety Committee (CSC)

- Support meeting preparations
- Develop review topics/CSC agenda items
- Support closure on recommendations

Product Safety Review meeting (PSRM)

- Develop agenda in concert with LPSP & PV Managers
- Present at PSRMs
- Review presentations of GDSRM MDs

Safety Management Team

- Support Meeting preparations and present data
- Develop review topics / SMT agenda items
- Support closure on recommendation

Literature Review

- Organize departmental resources and oversee weekly literature review process

PSUR/PSR Development

- Liaise with Lead Product Safety MD in development of strategy for PSUR/PSR
- Key participant in defining scope of PSURs/PSRs
- Key participant in development and writing of PSURs/PSRs
- Provide mentoring to Pharmacovigilance & Epidemiology physicians in the development of PSURs/PSRs, including Safety Topic Reviews
- Provide guidance in preparation of controlled documents for preparation of PSURs/PSRs
- Support GDSRM Project Manager in finalization of aggregate report schedule
- Integrate medical review team in PSUR generation and PSUR conclusions/actions (e.g. monitoring of specific events)
- Guide medical review in elaboration of follow-up templates & IME list maintenance

Response to Regulatory feedback to PSUR/ PSR

- Support regulatory authority Assessment Report responses
- Contribution and review PSUR/PSR responses
- Interaction with regulatory authority in response to feedback

Product Labelling

Labelling Working Group participation

- Participate in working group meetings as required

Core Data Sheet Creation

- Contribute to data sheet development

Issues management

Support the development of strategies for issue management

- Facilitate internal approval of plan
- Support review of issue data and closure on recommendations

Crisis Management

- Contribute to the formulation & specification of a rapid response system & corporate policy / procedure to address safety crises

Regulatory Enquiries

- Liaise with Lead Product Safety MD in development of strategy of response to regulatory enquiries
- Review of relevant data required for response
- Allocate and supervise resources for preparation of responses
- Support the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysis
- Develop response / Review draft responses by MDs as required

Safety Enquiries (Internal, External, HCP & consumer)

- Evaluation of safety enquiries
- Allocate and supervise resources
- Review response data

Safety Topic Review

- Strategy development and writing of Safety Topic Reviews
- Mentoring of Pharmacovigilance & Epidemiology physicians in development and writing of Safety Topic Reviews

Compliance, Standards, Training & Project Management

Preparation for Regulatory Inspection

- Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
- Support data entry conventions for aggregate data output
- Mentoring of Pharmacovigilance & Epidemiology physicians

Pharmacovigilance (approved products, incl further studies)

Safety PV processes

- Support safety PV process definition for Celgene products

Signal Detection and Analysis

- Support proactive, ongoing analysis of SAE’s by system, compound, and TA to detect significant correlation/causation
- Review of aggregate reports from other Pharmacovigilance & Epidemiology MDs as part of mentoring process for strategy definition
- Review of processes related to aggregate report / signal detection generation

Standard Operating Procedures

Develop / review / update SOPs for areas of functional expertese

Risk Management Plan & REMS Development

- Contribute to the definition of RMP and REMS drivers & content

Events of Interest management

- Definition of events of interest
- Definition of case follow-up needs

Pharmacoepidemiology

Global PE strategy

- Contribute to the development of a Global PE strategy

Key Requirements/Knowledge:

Qualifications

- MD (or international equivalent)
- Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred

Experience

- Ten (10) years relevant clinical experience, including training
- Five (5) years pharmaceutical/biotechnology industry experience
- Four (4) years in safety role

Knowledge

- Thorough understanding of global regulatory requirements for pharmacovigilance
- Clinical knowledge of therapeutic area patient populations and drug class

Competencies /Skills

- Ability to use scientific and clinical knowledge to conceptualize study designs
- Ability to anticipate and resolve problems
- Ability to lead cross functional efforts and teams
- Proficiency in data interpretation
- Clinical project management skills
- Excellent skills in oral and written communication
- Excellent interpersonal skills and ability to communicate effectively with people in different functions
- Good listening skills and a strong willingness/desire to help resolve issues faced by others around them
- Strong presentation skills
- Sound organizational skills

Direct and indirect reports:

- Some opportunity for line management

Decision making authority:

- Interpretation of safety data
- Strategy of aggregate reports including safety topics
- Feedback to colleagues on safety assessments
- Internal/external, departmental co-ordination

Internal/external partners:

- Drug Safety, both central and regional
- Clinical, Medical & Regulatory Affairs

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Sr_-Director%2C-Global-Safety-MD-%28Approved-Products%29-Job-NJ-07922/1753860/175386017538602012-06-14Celgene CorporationDrug Safetyfull-timeUSDstarting0BSBerkeley Heights, NJ, USIT
Neuchatel, Switzerland

PREREQUISITES

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

- Business Objects Universe development & unit testing
- Business Objects report development (WebIntelligence and Desktop Intelligence) from end-user specifications
- Business Objects/QlikView 2nd & 3rd line technical support through the helpdesk issue management system
- IBM DataStage ETL development for the International Data Warehouse, sourcing from ERP, MES, LSP’s (logistic service providers) and external data sources
- Maintenance and production support of live ETL applications
- Oracle & SQLServer database development in support of application development projects
- Project lead and contract management

Skills/Knowledge Required:

- At least 8+ years in IT application development and/or Business Intelligence ideally in the pharmaceutical industry
- A minimum of two of the following three:
- At least 5 years experience developing Business Objects (XI and higher) Universes and reports (Web Intelligence and Desktop Intelligence)
- At least 5 years experience developing IBM DataStage (7.0 and higher) ETL jobs in support of a data warehouse or data integration project
- Experience in web page development using an industry standard IDE, including ASP, JSP and .Net.
- Experience in Unix a significant plus
- Experience using formal project management methodologies, including MS Project
- Good PL/SQL or Transact-SQL development skills including debugging
- Strong in Oracle and/ Netezza including performance tuning and ad-hoc analysis,
- Experience of data modeling techniques & visualization tools (Erwin, Oracle Designer, etc) including formal data warehouse dimension modeling techniques such as Kimball or Inmon
- Exposure to database (Oracle and/orNetezza) administration and maintenance
- Strong inter-personnel skills, ability to use own initiative & solve problems, quickly adaptive to changing priorities, and self-motivated with the ability to prioritize workload
- Fluent French and English language skills (written and verbal), additional languages would be a plus
- Experience unix system, Good knowledge of Share point solution, OBIEE platform, Cognos, Micostrategy is a plus.]]>http://jobs.celgene.com/job/Neuchatel-Senior-BI-Specialist-Job/1753861/175386117538612012-06-14Celgene CorporationITfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Architect II (Active Directory/PKI)
Job ID: 12891
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: ITGOS Technology - 4163


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Master in relevant field (Computer Science, Electrical Engineering) preferred or equivalent Technical School training or equivalent work related experience that includes appropriate training courses, 7-10 years full-time Systems/Storage engineering and design experience in a corporate environment.

The responsibilities of this position include, but are not limited to, architecting and supporting IT infrastructure solutions with specific emphasis on Microsoft Active Directory and PKI technologies. The Senior IT Infrastructure Architect should have the ability to research, architect and implement hardware and software infrastructure solutions.

Responsibilities will also include, but are not limited to, the following:

1. Lead the Architects and Sr. Systems Engineers to design, develop/build Windows & Linux Servers, PKI, Active Directory and Messaging Infrastructure solution base on business requirements and design the automation for its delivery.
2. Design and implement process improvements as pertain to infrastructure in order to be more responsive and proactive to the business needs.
3. Lead Directory & Messaging system implementations, performance analysis and optimization, design systems monitoring, support problem resolution, upgrade planning and execution, as well as process creation and documentation in accordance with Pharma and regulatory compliance guidance.
4. Design and Implement Active Directory plans for new sites and integrations.
5. Oversee all high level Active Directory needs. Will be key contact for all high level AD needs.
6. Acts as a self-directed and self-motivated facilitator to lead peers through effort, example, and collaboration and works closely with the business and IT to develop cost effective, operationally supportable solutions that meet complex requirements.
7. Performs assessments on Active Directory environments and implements remediation’s as well assuring the stability, security, and scalability of all AD environments.
8. Participates in and coordinates cross-technology discussions to determine long term strategy for infrastructure technology and work with team to design and implement IT Infrastructure Solutions based on Industry standard platforms and regulatory compliances.
9. Implement process improvements as pertain to infrastructure in order to be more responsive to the needs of the business.
10. Follow standard operating procedures while maintaining validated/qualified systems.
11. Serve as the third level of support for problems that cannot be resolved by level one and level two engineers.
12. Provide strategic direction for technology components including operating systems, virtualization, storage technologies and network interconnectivity.
13. Perform periodic reviews of the Directory & Messaging infrastructure, including PKI health, directory structure and organization, directory replications, mailbox store health check and mail work flow to ensure compliance with standards and best practices.
14. Provide direction and advice to engineering and operations staff to perform maintenance activities to ensure a stable server and Directory & Messaging infrastructure.
15. Provide timely status updates to IT management
16. Provide leadership to Architects, Systems engineers and Systems analysts.
17. Architect and implement highly available & scalable Directory, Messaging and authentication solutions that not only meet business need and rapid growth but also protect valuable company data and applications.
18. Establish Global standards for IT infrastructure technology components.
19. Perform other job related duties as required


Skills/Knowledge Required:

- 4+ years experience in a multinational, 1000+ node environment company
- 5+ years Active Directory experience, including both design and operation
- 5+ years Windows 2003/2008 experience
- Experience with high availability/load balanced environments (Citrix Netscalers a plus)
- Experience with HTTP proxy and load balancers a plus
- Strong/proven design, implementation and operation experience with Microsoft Active Directory in a multinational company is a must.
- Demonstrated ability in staying abreast of technical developments in the industry and aligning them with strategic company objectives
- Organizational "Fit" Considerations: The candidate must be flexible to take on different tasks at short notice and have the ability to function in cross-functional team setup that consists of different disciplines.
- Prospective candidate must be able to work in a fast paced environment.
- Great documentation/design skills required as well as the ability to think conceptually.
- Excellent communication, organizations and analytical skills are required
- 2nd /3rd level on-call support on some nights and weekends and carrying a cell phone are required. Occasional late-night maintenance, alone at the corporate facilities, is required.
- Strong background in creating two-way trust and application LDAP dependencies.
- Strong written and oral communication skills in English is required

Education/Experience:

- ETS or HES degree, Bachelor or Master in Computer Science, Information Systems, Telecommunications, Electronics or equivalent experience that includes appropriate training courses and equivalent work-related experience is required.
- Microsoft certification such as MCITP/MCTS 2008 desired
- Other certifications on Linux, VMware, Networking or Security are a plus
- Experience working in a controlled environment with standard change management processes is a must.
- Pharmaceutical background and understanding of the CFR Part 11 and Sarbanes-Oxley regulatory requirements and experience with processes and procedures to apply and administer these and other necessary regulatory requirements in an operational environment is a plus.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Architect-II%2C-IT-Job-NJ-07901/1756215/175621517562152012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSSummit, NJ, USJob Title: Supervisor, QC Lab Services - 1st Shift
Job ID: 12892
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Quality Ops
Department: Quality Control - 1103


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Require a Bachelors degree in Chemistry or related science from an accredited college or university with a minimum of 5-8 years related experience in a regulated laboratory, preferably in a pharmaceutical laboratory environment.
- Require a solid knowledge of quality control systems, including FDA and DEA compliance standards, regulations, and guidelines.
- Demonstrates a solid knowledge and proven expertise in ICH guidelines for Method Validation.
- Requires excellent oral and written communication, organizational and teamwork skills.
- An equivalent combination of education, experience and training may substitute.

POSITION SUMMARY

The Supervisor, QC Laboratory Services, oversees method verification, transfer and validation activities for raw materials, In-Process and Finished Products. Oversees analytical development projects and performs compendia reviews and verifications. With limited supervision, develops stability protocols for demonstration and validation batches. Provides ongoing training support to the QC Chemistry Department in areas requiring technical expertise. As needed, assists with internal QC Chemistry audits.

ESSENTIAL FUNCTIONS

- Ensure timely support of process qualification activities, secondary standard qualification, and method verification,validation/transfer.
- Ability to troubleshoot method issues.
- Coordinate feasibility studies and review summary reports.
- Conduct investigations and deviations as required.
- Oversee the technical review of USP, EP, JP compendia and proposed revisions to ensure chemistry laboratory methodology and procedures are compliant with current standards.
- Ensure internal QC audits are thorough and completed in a timely manner.
- Write memos, reports, protocols and CAPAs and other technical documentation.
- Prepare, review and revise department SOPs, methods and worksheets.
- Collaborate cross-functionally to improve efficiency, solve problems, improve quality and provide new product support.
- Ensure employees are properly trained.
- Provide and ensure a safe and non-discriminatory working environment for employees.
- Participate in the hiring process and provide performance appraisals for direct reports.
- Perform other duties as required.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Supervisor%2C-QC-Lab-Services-1st-Shift-Job-AZ-85001/1758134/175813417581342012-06-14Celgene CorporationQuality Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Director, IT Global Delivery Services - Applications
Job ID: 12910
Location: Basking Ridge, NJ -106
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: IT - Applications - 4162


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Bachelor’s degree required. Advanced degree preferred.
- Minimum 8 years industry experience managing and implementing IT applications.

The Director of IT Global Delivery Services plays a key leadership role in the Applications area of IT Global Delivery Services at Celgene bearing primary responsibility for defining, leading and executing the strategic direction and oversight for Line of Business (LoB) applications and processes. This includes application oversight and the evaluation, implementation, integration and operation of the portfolio of LoB applications. The Director must excel at working in a collaborative, diverse, complex, resource-constrained environment and be able to lead decision-making processes that involve multiple constituencies and constraints. He or she will be expected to continuously improve systems and processes that fall within the range of their responsibilities.


Responsibilities will include, but are not limited to the following:

- Oversee all aspects of application implementations from vision, scope, design, development, implementation, deployment, maintenance, and support.
- Ensure IT staff, contractors and vendors operate according to all change management, SDLC and Standard Operating Procedures (SOPs) in the support of existing functionality, requested changes, projects, and in the development of new functionality.
- Develop and improve processes to effectively manage the company’s application portfolio.
- Deliver IT services that meet and exceed customer expectations.
- Ensure the ongoing support and availability for business-critical applications; examples include Clinical Systems, Quality Management & Compliance systems, FDA Risk Evaluation & Mitigation Strategy (REMS) systems, Medical Affairs Systems, Manufacturing & Distribution Systems, Information Technology Systems, etc.
- Participate in the IT mobile application development processes, primarily focusing on rendering relevant applications via mobile devices.
- Manage and maintain relationships with external vendors and consultants.
- Build and foster an effective IT team to enable future growth.
- Provide expert guidance, both technical and business, to team members and IT management.
- Develop and evaluate requirements and propose appropriate system solutions.
- Manage multiple priorities simultaneously, and meet project deadlines.
- Create a collaborative working environment among IT staff, end-users, and multiple levels of management.
- Define and manage ongoing knowledge management processes for applications.
- Fully understand changes in scope and schedule and how they will impact other business processes or projects.
- Help identify process improvements through changes in practice, standardization or through IT automation.
- Stay current on new industry based technical trends and application opportunities.
- Develop and control department budget appropriately.

Scope:

- Span of Control –Global application portfolio and related services.
- Direct Reports – 3 - 5
- Indirect Reports – 15 - 18
- Budgetary Responsibility – $4M OpEx plus additional CapEx.
- Interacts w/ - IT management and business management.


Skills/Knowledge Required:

- 8+ years of industry experience managing and implementing IT applications within the Pharmaceutical industry.
- Direct leadership and management experience leading an experienced IT applications team.
- Experience in planning and executing IT application projects from conception through implementation.
- Experience with all aspects of SDLC and familiarity with alternative approaches to it.
- Strong coaching and mentoring skills and understanding of how to motivate and challenge IT personnel.
- Ability to think strategically while balancing business imperatives with IT imperatives.
- Track record in delivering solutions that are scalable, extensible and easily enable future business needs is critical.
- Excellent written and verbal communication skills, including presentation ability.
- Negotiating skills, internally and externally, with customers and suppliers.
- Demonstrated complex systems development and integration expertise.
- Thorough understanding of best practices in project management, IT change management, release management, incident management, and SDLC.
- Demonstrated effective leadership skills in building high performance teams.
- Strong Experience with budgeting processes.
- Good knowledge and experience with ITIL process
- Excellent skills in communication, change management, staff mentoring, performance evaluation, life-long learning, and diagnosis of sources of problems in both systems and business processes.
- Must have prior experience leading project teams for implementation, customization, or enhancements to COTS systems, custom developed applications and mobile applications.
- Ability to work strategically and independently with internal and external groups on multiple projects.
- Must be client service-driven with excellent relationship management and analytical skills.
- Flexible, adaptable and hands-on approach necessary.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Basking-Ridge-Director%2C-IT-Global-Delivery-Services-Applications-Job-NJ-07920/1761775/176177517617752012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBasking Ridge, NJ, USMedical Affairs
Mississauga Ontario, Canada

THE POSITION: Under the direction of the Director, Medical Affairs Canada, the Senior Manager, Medical Information is responsible for managing all respective activities in relation to medical/scientific information, medical education, publication planning, and investigator-initiated publications. The Senior Manager, Medical Information will also be responsible for the management of Medical Information Specialists and all SOP/WP’s required to effectively provide Medical Information services that meet all internal and external standards and regulations. The Senior Manager, Medical Information may also represent Medical Affairs in some key internal working groups or teams with key Celgene Global stakeholders. Responsibilities include, but are not limited to: • Management of the Medical Information team and provide back-up support to MI • Development of the medical publication plan in Hematology/Oncology with subsequent execution to meet agreed timelines • Management of the IIT publication programme to ensure timelines for publication objectives are met • Review of promotional material to ensure compliance with Canadian regulations and Celgene values • Planning and management of specific data exploration and publication projects as assigned and consistent with the product strategies • Development and distribution internally, in a timely fashion, of educational materials, supporting upcoming publications • Presentation of data to internal and external audiences • Provide scientific support to team for Advisory- and Consultant meetings with KOL’s • Representation for Medical Affairs in Celgene internal teams, e.g. Therapeutic Area Teams • Management of Celgene Access Program, including tracking, metrics, and process. Skills/Knowledge Required: • BSc/MSc/PhD; scientific degree required; • 8+ years experience in the pharmaceutical industry • Relevant work experience in the pharmaceutical industry • Previous management/leadership experience • Interest in and affinity with scientific data analysis • Track record of medical writing and data review for scientific communication • Excellent skills in scientific data interpretation • Excellent communication and organization skills • Ability to work in a cross-functional team environment • Excellent skills in interacting with internal and external (KOLs, vendors) stakeholders • Scientific, clinical or research experience in the field of hematology/oncology/solid tumor • Experience and knowledge of the drug development and commercialization process • Excellent computer skills required, specifically Windows software, including Word, Excel and PowerPoint • Willingness to travel (minimal)]]>http://jobs.celgene.com/job/Mississauga-Senior-Manager%2C-Medical-Information-Quebec-City%2C-Quebec%2C-Canada-%2812-Month-Contract%29-Job-ON/1766029/176602917660292012-06-14Celgene CorporationMedical Affairsfull-timeUSDstarting0BSMississauga Ontario, CanadaMarketing
Mississauga Ontario, Canada

BSc/BA required; biological science degree helpful; MBA preferred. Minimum 5 years business analysis required with at least 3 years in the pharmaceutical/biotech industries. Responsibilities will include, but are not limited to, the following: • Development and maintenance of forecasting models (short-term and longer) for both in market Brands and new Brands • Partnering with Brand Teams and Therapeutic Area Teams in development of forecast assumptions and key Brand drivers down to provincial level • Detailed analysis of sales trends • Partner with Sales Operations Analyst to develop Provincial Forecasts and Regional Targets building up to National Targets • Development and maintenance of automated and custom Commercial reports from raw data • Preparation of sales and statistical data for Performance Dashboards, Brand plans • Providing of data to various teams and departments (Government Affairs, Finance, Sales, Marketing, Reg Affairs) • Reporting on key metrics to Global Team • Supports Commercial Review Team Skills/Knowledge Required: o BSc/BA required; biological science degree helpful but not required, MBA preferred o Excellent oral and written communication skills o 3-5 years in Pharmaceutical industry role o Strong analytical, problem-solving, and decision-making skills o Highly motivated self-starte, with ability to work in very dynamic environment with multiple competing priorities, demonstrating integrity, tenacity, flexibility and professionalism o Demonstrates a high level of initiative, planning, organization, and follow-up. o Team player with strong interpersonal skills o Project management skills o Ability to work independently and take the lead role on assigned project o Superior computer literacy including PowerPoint and advanced Excel skills o Forecasting software experience o Advanced knowledge of statistical analytical techniques o Intense curiosity to clearly understand business drivers Key Skills/Competencies required: Excellent written and verbal communication skills, negotiation, project management, accountability, and strength in financial skills, solid decision-making skills, integrity, trust, drive, motivation, and a strong sense of teamwork.]]>http://jobs.celgene.com/job/Mississauga-Business-Analyst-%2812-Month-Contract%29-Job-ON/1766030/176603017660302012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSMississauga Ontario, CanadaJob Title: Senior Director, IT GOS Security
Job ID: 12915
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: ITGOS Security - 4164


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

A talented individual with 15 years experience in all aspects of IT Security with at least 10 years of management experience. Outstanding track record in information security, including experience in guiding and assisting organizations in implementing appropriate IT security products and practices and excellent communication skills.

Description:

The Senior Director of IT Security (SDITS) will lead Global IT Security, overseeing the development and implementation of corporate-wide security and security principles, policies, and practices. The SDITS is responsible for coordinating all corporate activities with IT Security implications, as well as monitoring all of the organization’s services, systems, policies, and procedures to assure meaningful security practices.

Responsibilities include, but are not limited to, the following:

The Senior Director of IT Security (SDITS) will be responsible for creating and directing the activities of the corporate- wide global IT Security function including:

- Develop, implement and manage the overall enterprise processes for information risk management and associated architecture, policies and procedures.
- Develop and implement policies, standards and guidelines related to data security, disaster recovery and business continuity.
- Evaluate and provide direction in matters of privacy and privacy protection.
- Serve as the corporate focal point for security incident response planning, execution, and awareness.
- Oversee the development of, and be the enterprise champion of, a corporate security awareness-training program.
- Ensure IT security within individual business units through the deployment of a network of IT Security liaison or officers.
- Must possess an outstanding track record in information security, including demonstrated skills in guiding and assisting organizations in implementing appropriate IT Security products and practices.
- Position requires strong leadership skills and the ability to be effective in a decentralized environment.
- The ability to operate in an international environment and interact effectively with senior Business Unit management senior leadership.
- Participate in audit activities and audit report review with adequate action plan for IT Security related items.
- Develop and maintain an global strategy and roadmap for Celgene Information Security and Risk program, in collaboration and in alignment with our Enterprise Architecture directions and strategies.


Skills/Knowledge Required:

- A college degree (BA/BS) or equivalent work experience, advanced degree in business and/or technology would be a plus.
- Excellent communication skills, writing and public speaking
- International experience
- Ability to interface with top management as well as the diverse cultures of domestic and international corporate and IT security.
- At least 15 years of corporate, private industry experience demonstrating exposure and some level of expertise in IT security
- At least 10 years in management experience
- At least five years’ experience in a security-related thought leadership or management capacity
- Outstanding track record in information security, including experience in guiding and assisting organizations in implementing appropriate IT security products and practices
- Experience in a equivalent position in the Pharmaceutical industry would be a definite plus.

Other desired qualities include:

- A developed network of security providers, contacts, and knowledge of differing policies procedures and regulations in international arenas.
- Business-based attitude, i.e., the recognition that no policies can be implemented without demonstrable business benefit.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Senior-Director%2C-IT-GOS-Security-Job-NJ-07922/1766031/176603117660312012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Senior Clinical Research Associate, Nashville, TN
Job ID: 12919
Location: OffSite
Offsite Territory: Nashville, TN
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Clinical Operations - 3603


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- BS / BA / RN; scientific degree preferred - 8+ yrs experience in the pharmaceutical/medical industry OR - 3+ yrs at Level II or Equivalent

- Significant impact on function and study monitoring teams - Serves as Monitoring Lead for a study - Mentors Level I and II - Participates in training within function - Oversees completion of functional SOPs/WPs - Through interactions with assigned investigative sites, utilizes established productive relationships with site staff to increase Celgene’s corporate image and future research success - Conducts field assessment with CRO monitors - Executes tasks and responsibilities that deliver corporate goals and may drive goal setting for the functional group

- Fully independent - Independently manages assigned sites to timelines - With minimal guidance, sets own priorities for activities that are required to achieve the corporate and study deliverables; may also do so for levels I & II as required

- Anticipates and prevents problems - Evaluates problems and implements solutions with back up plans as necessary - Has ability to solve multiple problems with varying degrees of complexity for multiple functions - Leads and completes best practices - Recognized as a source of innovative solutions - Viewed as expert in monitoring skills - Leverages industry best practices

- Influences study monitoring teams - Understands/communicates overall project/program strategies - Provides input to function and cross functional teams - Develops and implements initiatives and best practices - Capitalizes on broad, well established relationships and networks - Performs management tasks as assigned by line management

- Significant knowledge of clinical trial process - Significant knowledge of monitoring - Proficient in writing function SOPS / Work Practices - Expert in regulatory guidelines, agencies, GCP - Excellent written and oral communication skills - Expert in a number of diseases, treatments, and compounds - Significant knowledge of medical terminology - Responsible for developing study monitor plans - Prepares and presents at investigator meetings - Significant site management skills - Knowledge of MS Office - Significant knowledge of E-systems (Inform, CTMS, etc)

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Nashville-Senior-Clinical-Research-Associate%2C-Nashville%2C-TN-Job-TN-37201/1766033/176603317660332012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSNashville, TN, USManufacturing
Zofingen, Switzerland

PREREQUISITES

Chemist or Chemical Engineer, Bachelor’s or Master’s degree

Fluent in English and German

Valid Swiss working permission or EU Citizenship required

Under the direction of the Director, Manufacturing this individual will be responsible for managing external as well as internal API (Active Pharmaceutical Ingredients) projects and will be responsible for assigned business relationships related to commercial API supply.

Responsibilities include, but are not limited to:

Main liaison to Process Development (PD, based in Summit, NJ

- Acquires process know how from PD of API processes going through process validation and entering commercial phase, both at third party vendors and Celgene Chemicals
- Supports PD during process validation
- Follows development projects and gets involved in decisions influencing future commercial activities
- Organizes yearly workshop between Celgene Chemicals and PD

Technical liaison in Vendor Quality Management Teams

- Is primary contact to process and analytical functions at vendor. Supports vendor in trouble shooting situations in collaboration with subject matter experts (SMEs) from PD and from Analytical Research and Development (AR&D)
- Reviews and assesses Change Requests, Deviation Reports, new versions of MBRs, major process changes, analytical method changes, spec changes, etc.; in collaboration and alignment with PD and while seeking guidance from Regulatory CMC department.
- Supports business owner with supply chain management
- Supports QA liaison (participates in audits at vendor; batch record review, etc.)

API manufacturing and project activities

- Responsible for keeping track of overall process performance of commercial API processes at vendors and at Celgene Chemicals (in collaboration with Manager, Manufacturing).
- Initiates necessary projects and carries them out (in collaboration with PD, Manager, Manufacturing (for internal projects), and functions at respective vendor)
- Establishes metrics for own and vendor API processes. Requests the necessary data from vendor or Manager, Manufacturing, compiles them and delivers presentations (dash boards, KPI’s, management presentations)
- Is deputy of Manager, Manufacturing (at Celgene Chemicals)
- Oversees and schedules commercial API Starting Materials (API SM) supply (for Celgene Chemicals and 3rd party, if applicable)
- Is business owner of relationship to API SM suppliers
- Process performance of API SM manufacturing: In collaboration with PD, identifies gaps and suggests measures. Keeps multiple suppliers aligned.
- Initiates and leads vendor qualification activities together with QA.

Skills/Knowledge Required:

- Background in Chemistry or Chemical Engineering (Bachelor or Master)
- Oriented to / experienced in development, manufacturing, project management
- Experience in GMP environment. Excellent understanding of quality and compliance risks
- Fluency in English and German
- Ability and willingness to take ownership. Seeks responsibility
- Effective, competent communication style
- Conveys the Celgene values and strategy. Strong identification with Celgene’s values
- Effective project management skills
- Experience or at ease in an international and fast growing environment]]>http://jobs.celgene.com/job/Zofingen-Senior-API-Project-Manager-Job/1768070/176807017680702012-06-14Celgene CorporationManufacturingfull-timeUSDstarting0BSZofingen, SwitzerlandJob Title: IT Lead Analyst, Clinical
Job ID: 12935
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: IT - Applications - 4162


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

This position is for an experienced Clinical Application Analyst to support Oracle Seibel, EDC and Oracle Clinical applications. This position will require strong understanding of the business process and strong integration knowledge on various Clinical applications.

- Expertise in Siebel Workflows
- Rich experience with Siebel integration techniques and use of Integration Objects, Data Maps, Web Services etc.
- Experience in web services and/or queue based integration
- Experience in Synchronous and Asynchronous Integration techniques
- Provide data mapping for Business Objects, Business Components, Fields, Joins, Links, Applets, Views, Screens, User Properties, Drilldowns using Siebel Tools.
- Provide technical design documentations and unit test plans.
- Provide support in mapping business requirements to vanilla Siebel functionality and identifying functional gaps and options / strategies to resolve.
- Working knowledge of Siebel environments, hardware configuration, and architecture is a plus
- Siebel VB or Siebel e-script experience
- Actuate Reports with Siebel

Knowledge to support EDC and Oracle Clinical Applications

- Designs and implements library level and study specific setup for clinical trials applications ( EDC)
- Serves as Technical Operations Lead on Study specific database design / build activities Reviews designs for compliance/feasibility within the database system and consistency with any current standards and/or sponsor specifications
- Assists in the maintenance/update of TMS dictionaries and the processes surrounding them
- Performs core setup and supports processes for systems
- Consults and supports all database/system users as necessary to allow users to effectively use these systems Works with IT in troubleshooting, reporting and resolving system issues

Qualifications:

- Supporting and implementing IT systems for a minimum of 9 years, experience working with Oracle, SQL, and Oracle Pharmaceutical Applications suite (EDC, Oracle Clinical, Seibel or similar Clinical suite is highly desired.
- Experience implementing and supporting validated, 21 CFR Part 11 compliant computer systems.
- Possesses understanding in the areas of application programming, database and system design.
- Strong problem-solving skills and the ability to independently troubleshoot as well as develop alternative solutions to problems.
- Good interpersonal skills including the ability to interact well with a variety of personalities, craft skills and educational levels.
- Demonstrated ability to deliver on commitments; able to define and prioritize realistic goals and objectives

Key Skills

Siebel 8.0 and up (e Clinical, Sales, Service, Order Management)
EIM - Enterprise Integration Management
EDC – working knowledge
Oracle Clinical – working knowledge
VB, ASP, XML, XSLT, .NET (knowledge)

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-IT-Lead-Analyst%2C-Clinical-Job-NJ-07922/1768073/176807317680732012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Sr. Director, Lead Global Product Safety Physician
Job ID: 12937
Location: Warren Township, NJ - 33
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Drug Safety
Department: Drug Safety - 4202


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Minimum of completed MD (or international equivalent) plus accredited clinical residency experience required
- At least 10 years experience as an MD in clinical research required
- At least 5 years pharmaceutical industry experience required
- At least 3 years drug safety experience required
- Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred.
- Experience/background in Immunology-Inflammation desirable.

This position will be working with the Immunology-Inflammation (I&I) franchise.

- To create and maintain a single interpretation of global safety data for defined products in development
- To identify and manage safety concerns with Celgene development products
- To assist the Medical Affairs study teams in pursuit of team goals
- To provide a robust assessment of developmental product safety upon which marketed product safety surveillance may be based

Responsible for:

- Identifying and managing safety concerns for pre-approval Celgene products
- Assisting Medical Affairs trials teams in the identification and handling of product safety concerns
- Creating co-ordination at the product level across the Global Drug Safety Dept
- Maintaining knowledge of safety profiles for treatments in a specific therapeutic area, including both Celgene and competitor products

Key Activities:

Governance

- Product Development Committee
- Product Development Team Participation
- Study Review Committee Representation
- Company Safety Committee (CSC)
- Internal DMCs
- External DMCs

Product Labeling

- Labelling Working Group participation
- Core Data Sheet Creation
- Core Data Sheet Maintenance
- Package Insert

Key Requirements/Knowledge:

- Minimum of completed MD (or international equivalent) plus accredited clinical residency experience required
- At least 10 years experience as an MD in clinical research required
- At least 5 years pharmaceutical industry experience required
- At least 3 years drug safety experience required
- Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred
- Mastery of global regulatory requirements for pharmacovigilance
- Clinical knowledge of therapeutic area patient populations and drug class
- Knowledge of clinical research techniques and analysis methods
- Issue and crisis management

Leadership Competencies

- Drive Innovation
- Shape Strategy
- Attract and Develop Talent
- Promote Open Communication
- Create Global Mindset
- Demonstrate Adaptability
- Foster Risk Taking
- Foster Teamwork

Competencies /Skills

- Ability to use scientific and clinical knowledge to conceptualize study designs
- Ability to anticipate and resolve problems
- Ability to lead cross functional efforts and teams
- Proficiency in data interpretation
- Excellent skills in oral and written communication
- Excellent interpersonal skills and ability to communicate effectively with people in different functions
- Good listening skills and a strong willingness/desire to help resolve issues faced by others around them
- Strong presentation skills
- Sound organizational skills

Internal/external partners:

- Clinical Development
- Medical Affairs
- Clinical Investigators/KOLs
- Global Regulatory Internal/External
- Trial Safety Managers & other Global Safety MD

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Sr_-Director%2C-Lead-Global-Product-Safety-Physician-Job-NJ-07922/1768074/176807417680742012-06-14Celgene CorporationDrug Safetyfull-timeUSDstarting0BSWarren Township, NJ, USJob Title: Sr. IT Infrastructure Architect
Job ID: 12943
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: ITGOS Technology - 4163


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

Master in relevant field of Computer Science, Information Systems, Telecommunications, Electrical Engineering preferred or equivalent Technical School training with 9+ years Infrastructure Architecture experience or equivalent work related experience that includes appropriate training courses, plus 8 years full-time Wintel Systems, Active Directory, PKI, Network and Storage engineering/design or relevant technologies experience in a corporate environment.


Summary

The responsibilities of this position include, but are not limited to lead architecting, design and supporting, IT infrastructure solutions with specific emphasis on designing, architecting building and delivering end-to-end corporate systems that meet business needs. The Senior IT Infrastructure Architect-3 should have the ability to lead research, architect and design qualify hardware and software infrastructure solutions base, on business requirements & best practices in the Pharmaceutical industry.

Responsibilities will also include, but are not limited to, the following:

- Lead the Architects and Sr. Systems Engineers to design, architect, configured/build Windows & Linux Servers, PKI, Active Directory, Messaging, Network, WAN, LAN, PBX, VoIP, Storage and VMware Infrastructure solution base on business requirements and design the automation for its delivery in an stable, secure, and efficient manner.
- Design and implement process improvements as pertain to infrastructure in order to be more responsive and proactive to the business needs.
- Lead Active Directory & Messaging system design, performance analysis and optimization, design systems monitoring, 3rd level support problem resolution, upgrade planning and execution, as well as process creation and documentation in accordance with Pharma and regulatory compliance guidance.
- Perform storage implementations, performance analysis and optimization, storage systems monitoring, problem resolution, upgrade planning and execution, and process creation and documentation in accordance with Pharma and regulatory compliance guidance.
- Acts as liaison to IT and business to gather infrastructure requirements for technology solutions.
- Performs evaluation of OS, Storage, Servers, Virtualization, AD Components and other shared Infrastructure technology alternatives and their respective risks assessment/costs.
- Acts as a self-directed and self-motivated facilitator to lead peers through effort, example, and collaboration and works closely with the business and IT to develop cost effective, operationally supportable solutions that meet complex requirements.
- Develops project cost and benefit estimates to establish project worth; including alternative considerations leading to recommendations for new systems or equipment installations, or change to existing ones.
- Participates in and coordinates cross-technology discussions to determine long term strategy for infrastructure storage technology and work with team to design and implement Server/Storage Solutions based on Industry standard platforms and regulatory compliances.
- Implement process improvements as pertain to infrastructure in order to be more responsive to the needs of the business.
- Follow standard operating procedures while maintaining validated/qualified systems.
- Serve as the third level of support for problems that cannot be resolved by level one and level two engineers.
- Provide strategic direction for technology components including operating systems, virtualization, storage technologies and network interconnectivity.
- Perform periodic reviews of the Directory & Messaging Infrastructure; including PKI health, directory structure and organization, directory replications, mailbox store health check and mail work flow, to ensure compliance with standards and best practices.
- Perform periodic reviews of the storage infrastructure, including HBA firmware levels, switch firmware and storage firmware to ensure compliance with best practices.
- Provide direction and advice to engineering and operations staff to perform maintenance activities to ensure a stable storage and server infrastructure.
- Provide timely status updates to IT management
- Provide leadership to Architects, Systems engineers and Systems analysts.
- Architect and implement highly available & scalable Systems, Directory, Messaging, Authentication, and Storage Area Network solutions that not only meet business need and rapid growth but also protect valuable company data and applications.
- Establish Global standards for IT infrastructure technology components.
- Perform other job related duties as required


Skills/Knowledge Required:

- 8+ years full-time Wintel Systems, Active Directory, Storage engineering/design or relevant technologies experience in a corporate environment
- 6+ years, IT Experience in Pharmaceutical Industry or equivalent is a must
- 5-7 years Red Hat Enterprise Linux experience required
- 5-7 Years Windows 2003/2008 experience required
- 5-7 years VMware 3.x & 4.1 Virtualization experience is required
- 5-7 years experience with the IBM Servers and IBM or EMC Storage portfolio is a must
- 3-5 years systems and Storage virtualization and administration experience required
- 3-5 years MS Terminal Server and Citrix Presentation Services is a must.
- 3-5 years Network WAN, LAN, PBX and VoIP experience is required
- IBM System X and Blade Server experience is a must
- Experience with Microsoft high availability/load balanced environments is a must.
- IBM Blade Center engineering design experience is required
- Strong/proven implementation and design experience with IBM Storage (DS4000/5000, XIV SVC ), EMC CLARiiON, VNX as well as Cisco SAN Switching (MDS9000) is a must
- Demonstrated ability in staying abreast of technical developments in the industry and aligning them with strategic company objectives
- Organizational "Fit" Considerations: The candidate must be flexible to take on different tasks at short notice and have the ability to function in cross-functional team setup that consists of different disciplines.
- Prospective candidate must be able to work in a fast paced environment.
- Great documentation/design skills required. Ability to think conceptually is a must.
- Excellent communication, organizations and analytical skills are required
- On-call support on some nights and weekends and carrying a cell phone are required.
- Occasional late-night maintenance, alone at the corporate facilities, is required.
- Must be able to physically lift and move servers and storage equipment.
- Familiarity with databases and web programming languages desired
- Great documentation/design skills and convert business requirements into technical are a must
- Ability to drive strategic solution and think conceptually is a must.
- Ability to lead SMEs/Architects as well as design, document and lead the Infrastructure enterprise architecture strategy is a must
- Some Domestic and International travel may be required.

Education/Experience:

- Master in relevant field of Computer Science, Information Systems, TelecommunicationsElectrical Engineering is preferred or equivalent Technical Institute training that includes relevant training courses, certifications and 9+ years equivalent work-related experience is required.
- IBM Server and EMC or IBM Storage platform certification is required.
- Microsoft Windows Systems, and Active Directory certifications are strongly required
- Linux and VMware Certifications are desired
- CNE or higher Certification is required
- ITIL 3.0 Certifications and experience are desired
- Experience designing/implementing IBM Server solution is must
- Experience designing/implementing IBM Storage in a redundant Cisco switched fabric environment with at least 100 hosts is required
- Experience with working in controlled highly regulated environment with standard change control management processes is a must
- Pharmaceutical background and understanding of the CFR Part 11 and Sarbanes-Oxley regulatory requirements and experience with processes and procedures to apply and administer these and other necessary regulatory requirements in an operational environment is a must.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120509
]]>http://jobs.celgene.com/job/Berkeley-Heights-Sr_-IT-Infrastructure-Architect-Job-NJ-07922/1770112/177011217701122012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Senior Manager, Market Research
Job ID: 12941
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Marketing
Department: Marketing Excellence - 2241


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BS/BA required; biological science degree helpful; MBA preferred

The Market Research Manager will design, plan and execute all assigned market research projects in support of all Celgene products including new indications in the U.S; Canada; Latin America.

Responsibilities will include, but are not limited to, the following:

- Plans, designs, implements and manages primary market research projects and provides final analysis including recommendations to the MR Director and others within Market Research; Brand management, Sales, and other Celgene departments.

- Works with Market Research, Brand management, Cross –functional project Teams, Sales, Clinical Development and other Celgene departments to frame MR parameters and provide input for both tactical and strategic decision-making.

- Works as key interface between Market Research and Business Analytics/Sales Operations to analyze and synthesize information in internal data bases (ex.COMS). to assist in marketing decision making.

- Displays knowledge on a broad range of analytical and MR techniques and appropriate use in MR studies..

- Manages all Market Research activities within the assigned franchise areas and reports status to Director, Market Research and other sales and marketing personnel as required. Takes lead role in analyzing, interpreting, and presenting study results to all necessary parties within Sales and Marketing..

- Experience in conducting MR in Canada and Latin America.

- Demonstrates a commitment to high quality research, cost efficient & timely research.


Skills/Knowledge Required:

- BS/BA required; biological science degree helpful but not required
- MBA strongly preferred
- 5-7+ years market research with a minimum of 3+ years experience in the pharmaceutical/biotechnology industry
- Oncology and/or inflammatory market experience strongly preferred
- Pharmaceutical sales experience desirable
- Working knowledge of statistical analytical techniques
- Global Market Research experience desirable
- PC literate including Word, PowerPoint and advanced Excel skills
- Excellent oral and written communication skills required

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Manager%2C-Market-Research-Job-NJ-07901/1770114/177011417701142012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSSummit, NJ, USJob Title: Senior Director, IT Enterprise Architect
Job ID: 12916
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: IT–Global Architecture & Admin - 4171


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Enterprise Architecture senior leadership experience with 15 plus years of architecture/engineering, 7 plus years as a global IT executive, BS in EE, MIS, Computer Science or related study

Summary:

As a member of the Enterprise Architecture leadership team and global authoritative architect of technology capabilities and enterprise platforms, responsible for shaping technology capability strategies and road maps, developing platform directions, defining technology standards, and fostering technology innovation, in support of Celgene’s goals and strategy. The IT leader must demonstrate cross-organizational leadership, providing vision and strategy and ensuring business and technical solution architectures are developed aligned to the defined capability road maps. The successful candidate must be knowledgeable of a broad set of technology capabilities and platforms, and be equally comfortable getting into the details as well as operating at the strategic enterprise level.

Celgene is seeking a results oriented leader in technology architecture with in-depth knowledge of industry technical trends, business process and information and an in depth knowledge of technology solutions. This is a leadership position with a high degree of influence - success criteria for architectures and roadmaps is measured by the impact on IT planning and portfolio investments decisions. Incumbent is a recognized expert within enterprise architecture and other IT/business domains globally and directly influences the outcomes of Celgene’s architecture and IT initiatives; while influencing business strategies.

Responsibilities will include, but are not limited to, the following:

As a leader in helping Celgene establish and reach its desired business solutions and technology landscape, the incumbent creates the architecture strategies, directions and roadmaps needed to achieve the desired future landscape.

- Provides thought leadership to various IT initiatives and leadership teams. Activities are globally scoped
- Researches new IT capabilities; decides their relevancy to Celgene's IT/business environments and plans in collaboration with IT leadership the introduction of these capabilities into the environment to support the strategies of the business and IT
- Develops Reference Architectures (Conceptual and Logical views) to support required business capabilities
- Functions as the most senior and authoritative Technical Architect for the company, ensuring the direction is driving the highest business value
- Functions as most senior Solution Architect and drives solution plans when new platforms or technical capabilities are to be introduced
- Produces "best-practice" guides and advises projects regarding technological risks and opportunities to ensure decisions are well informed
- Maintains expertise in numerous technical architectures and is a valued resource to IT and business communities.
- Promotes the advancement of Celgene's IT including, optimization of it’s operating model, development of EA frameworks, and foster the institutionalization of consistent architecture practices across the organization;


Skills/Knowledge Required:

BS in Electrical Engineering, MIS, Computer Science or related study required, MBA is a plus.

Scope:

- Span of Control – Global, cross functional, enterprise technology capabilities
- Direct Reports – 0 short term, 2 to 6 long term
- Indirect Reports – will direct the work of a matrix group within IT of approximately 25 to 50
- Budgetary Responsibility – High influence on significant aspects of the IT budget of $80MM Capital, $120MM Expense
- Interacts w/ - CIO, IT Executive Directors, IT Directors, Business Executives and Directors, External Business Partners

- Demonstrated ability to interpret technology and market trends as a foundation for technology strategies and roadmaps.
- Demonstrated experience of driving the solution planning of at least three large scale business solutions that included the introduction of at least one new enterprise platform
- Excellent interpersonal and communication skills. Must have ability to: a) effectively interact with executive and senior management to assess technology requirements and communicate architecture directions and solutions; b) effectively lead matrix projects with global implications; c) create required architectural models and roadmaps; d) integrate architectures at the conceptual and logical levels, and assess appropriate solutions; e) work effectively as a team leader and team member.
- At least 15 years in architecture/engineering, with 7 in an executive-level position within a global environment. Must include recent Enterprise Architecture experience. High preference will be given to experience in Pharma.
- Hands on knowledge of enterprise architecture (in general) with regard to business, information, and solution architecture, and two (preferably more) of the following Technology Architecture sub-disciplines: technical/solution architecture, reference architecture, Infrastructure (Servers, Storage, Data Centers, Devices), Mobility, Cloud, Networks, Security ; proven ability to apply this knowledge within a business context. Demonstrated expertise in long-range planning.
- Direct experience driving technology platforms for most of the following is a must: Sharepoint and the broad Microsoft stack, Mobility including device management, application management with iPhone and iPad, regulated content management with Documentum or Live Link, Oracle (middleware, data management, and application suite), Collaboration (OCS, Lync)
- Experience designing and implementing one or more of the following is a plus; EA processes, tools and repositories, IT business processes and solutions (ITIL, ITSM), or Portfolio Management.
- Consulting background with one of the top tier IT/business management consulting firms is a strong plus

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Senior-Director%2C-IT-Enterprise-Architect-Job-NJ-07922/1774214/177421417742142012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Principal Medical Writer
Job ID: 12955
Location: Warren Township, NJ - 33
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Scientific & Medical Writing - 3673


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Completed BA/BS with 5 or more years of professional working experience as a Medical Writer supporting Regulatory Submissions required.
- Must have experience in preparing clinical documents including Investigator’s Brochures, clinical study reports, integrated summaries of efficacy and safety, registration dossiers, and responses to health authorities.
- Must be knowledgeable in industry trends for study reports and international dossier preparation, including electronic document submissions (eCTD).

Responsibilities will include, but are not limited to, the following:

- Working with other relevant line functions, prepare clinical documents in support of regulatory submissions, including Investigator’s Brochures, clinical study reports, integrated summaries of efficacy and safety, registration dossiers, and responses to health authorities.
- Participate in study and clinical team meetings and assist the teams in resolving issues related to document preparation.
- Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
- Prepare templates for clinical documents that are consistent with FDA and ICH guidelines and with electronic submission guidelines.
- Develop the strategy for document preparation, including time frames that meet or exceed company standards and the document review processes.
- Facilitate document review meetings and discussions.
- Participate in the development of outsourcing plans for medical writing.
- Manage outsourced medical writing projects.
- Review work of other writers (in-house or contract) for accuracy, quality, focus, and adherence to format and stylistic requirements.
- Train and guide other writers (in-house or contract) in company policies and procedures related to document preparation.
- Assist with transferring and presenting clinical / regulatory data to Marketing for journal submissions.


Skills/Knowledge Required:

- Ability to interpret and analyze scientific and medical data
- Proficient with the use of Word and electronic templates
- Familiarity with ICH and health authority guidelines pertaining to submission relevant documents
- Scientific or medical background as applicable
- Excellent grammatical and communication skills, both written and oral
- Knowledge of electronic document repository use
- Knowledgeable in industry trends for study reports and international dossier preparation, including electronic document submissions (eCTD)
- Ability to train others writing skill sets
- Experience working with CROs
- Ability to work with complex projects and within cross-functional teams
- Ability to search and scan various internal and external databases, i.e. Pub Med, Gen Bank, Library of Congress. Identify internal resource information that would aid in completion of the task.
- Experience writing all types of clinical and regulatory documents

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Warren-Township-Sr_-Medical-Writer-Job-NJ/1774215/177421517742152012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSWarren Township, NJ, USJob Title: Validation Principal Scientist
Job ID: 12958
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Aseptic Operations - 1117


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a Bachelors degree in Science or Engineering from an accredited college or university with a minimum of 10 years related validation experience in a regulated industry, preferably with at least five years in the pharmaceutical or related industry.
- Validation experience must include some or all of the following: life cycle validation of common laboratory systems, laboratory information management systems (LIMS), process automation, PLCs, DCS, building management systems, SCADA, IT network and infrastructure, ERP systems (SAP), and other GxP systems used to support commercial manufacturing in a regulated environment.
- An equivalent combination of education, experience and training may substitute.

POSITION SUMMARY

The Validation Scientist, Principal is responsible for managing Validation activities for Computerized Systems through the complete validation life cycle. Serves as a Subject Matter Expert in computerized systems validation and provides expert technical recommendations / guidance. Leads large scale projects, prepares and leads project schedules/project teams, executes complex validation studies, and performs and interpolates associated data analysis.

ESSENTIAL FUNCTIONS

- Interface with engineering, validation, IT, and end user groups as a subject matter expert to provide technical guidance with computerized systems validation including but not limited to GAMP methodologies, software development life cycle, process automation, system specifications, 21 CFR Part 11 and other GxP regulations.
- Designs the qualification approach, provide the scientific rationale and acceptance criteria, generate and approve validation protocols and assist other department members in conducting industry and regulatory research including research into industry standards/FDA guidelines for validation equipment / processes and make determinations regarding acceptance criteria and testing.
- Leads projects, prepare project schedules and execute validation studies, perform complex data analysis and write protocol summaries, reports, and technical reports
- Design and implement validation programs related to computerized systems validation, including alarm management, backup and restoration, disaster recovery, knowledge and information management, and vendor audit and selection.
- Manage projects in the work group and leading specific project teams (and multiple projects), coordinating the execution of computerized systems validation projects, prepare project schedules and providing presentations to senior management / stakeholders on project status.
- Coordinate and lead other Validation Scientists in the work group and provide technical expertise related to computerized systems validation.
- Within area of expertise provide training to groups and mentor individuals.
- Write, review and revise department applicable SOPs, Plans and Programs.
- Coordinate department validation testing within the production schedule and provides back up in absence of validation management.
- Participate and defend validation approaches in regulatory audits.
- Write and process change controls, assess impact to process validated and lead validation non-conformance investigations associated with qualification activities.
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120323
]]>http://jobs.celgene.com/job/Phoenix-Prin-Sci-Validation-%28Computer%29-Job-AZ-85001/1774218/177421817742182012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Director, Oncology Cross-Franchise Initiatives and Strategic Marketing
Job ID: 12952
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Marketing
Department: Product Marketing - 2231


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BA required. MBA preferred , Prior Marketing Experience Required

Responsibilities will include, but are not limited to, the following:

1. Reports to Senior Director, Oncology Marketing and works cross functionally within Marketing, Medical, Project Teams, Medical Affairs, and Global to support the US pre-launch planning of new products and line extensions in Celgene’s product portfolio for the Solid Tumor Franchise
2. Involvement in business development opportunities: providing analysis and input to best inform the evaluation of licensing and acquisition opportunities for Solid Tumor Franchise.
3. Identify/develop/project manage innovative tactical solutions for critical franchise opportunities and develop execution framework for brand team including closed loop marketing initiatives, speaker bureaus, non-personal and digital solutions, internal communications and PR initiatives
4. Develop and drive the brand planning process across the franchise
5. Manage external vendors and agencies including identifying new vendors that bring innovative approaches, work with procurement and marketing operations to negotiate rates and find efficiencies across the franchises and anticipate issues and find creative solutions to optimize agency output
6. Develop budget management process by creating franchise reports to help manage expenses for the franchise throughout the year
7. Liaise with commercial training to develop training initiatives to support marketing career ladders and drive marketing excellence initiatives
8. Partner closely with Hematology Marketing team to share and develop best practices across franchises related to marketing solutions


Skills/Knowledge Required:

- Successful candidate should have at least 10 years industry experience with 6+ years of marketing experience, with at least 2 years in-line oncology experience. Prior Marketing/ Strategic Planning/ Consulting experience in oncology required,
- Strong analytical and strategic thinking skills required
- Strong communication and presentation skills
- Strong scientific background, or evidence of ability to grasp understanding of scientific concepts

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Director%2C-Oncology-Cross-Franchise-Initiatives-and-Strategic-Marketing-Job-NJ-07901/1774219/177421917742192012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSSummit, NJ, USJob Title: Director / MD, Clinical R&D
Job ID: 12953
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Hematology/Oncology - 3606


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Minimum M.D. or PhD degree and substantial medical/clinical training in Therapeutic Area or a related field
- Minimum 3-5 years of experience designing, leading and managing significant clinical trials in the Therapeutic Area
- Direct industry experience is preferred; substantial experience working on industry-sponsored trials will be considered.

The Clinical Research Physician, Therapeutic Area will be instrumental in supporting the growth of the Company's Therapeutic Area infrastructure as the organization continues to build the value of the current products and develop new products. The incumbent will have hands-on responsibility designing and executing clinical trials, and running programs focused on Therapeutic Area, and will exhibit a passion for Phases 1 through 3, including biomarkers, proof-of-concept and full development. This position offers potential growth opportunities to the right candidate possessing a combination of intellectual and execution skills and a love of the science.

Core Responsibilities:

- Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards.
- Lead the Clinical Protocol Team, including interactions with discovery, safety, marketing, regulatory, research and other functions.
- Write protocols that are in-line with the overall indication strategy
- Present at Investigators’ Meetings
- Conduct medical review and interpretation of efficacy and safety data from clinical trials.
- Have responsibility for the quality, coordination, medical accuracy and timeliness of clinical study reports.
- Work with Therapeutic Area Head and other team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
- Assist senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, and clinical expert reports.
- Present and discuss data and findings at relevant team, governance, KOL and regulatory meetings.
- Establish and maintain working relationships with Study investigators, key opinion leaders, academicians, and Celgene Senior managers and department heads across the corporation
- Ensure adherence to GCP/ICH and Celgene Standard Operating Procedure (SOP) standards.
- Maintain clinical and scientific awareness in area of expertise
- Guide and possibly manage the day to day work of Clinical Research Scientists.
- Manage lifecycle requirements and plans for designated indications.

Key Requirements/Knowledge:

- Minimum M.D. or PhD degree and substantial medical/clinical training in Therapeutic Area or a related field.
- Minimum 3-5 years of experience designing, leading and managing significant clinical trials in the Therapeutic Area
- Direct industry experience is preferred; substantial experience working on industry-sponsored trials will be considered.
- Understanding of drug development process.
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
- Experience in designing Clinical trial strategies to obtain regulatory approval.
- Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product.
- Ability to develop and evaluate strategies for the clinical development of a designated indication and to critically evaluate outside expert advice.
- Experience in Clinical project planning.
- Experience working on global and complex Clinical trials.
- Experience working effectively in a team/matrix environment.

Celgene Leadership Competencies

- Drive Innovation
- Shape Strategy
- Attract and Develop Talent
- Promote Open Communication
- Create Global Mindset
- Demonstrate Adaptability
- Foster Risk Taking
- Foster Teamwork

Competencies /Skills

- Strong scientific/technical skills
- Strong interpersonal capabilities and ability to build networks
- Ability to anticipate and resolve problems
- Ability to lead cross functional efforts and teams
- Excellent verbal communication and technical writing skills
- Ability to present clearly using scientific and clinical terminology
- Excellent interpersonal skills and ability to communicate effectively with people in different functions
- Sound organizational skills
- Possesses sense of urgency and can take initiative
- Ability to motivate team members
- Project management skills and focus on delivery of results

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Director-MD%2C-Clinical-RD-Job-NJ-07901/1774220/177422017742202012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSSummit, NJ, USJob Title: Associate Manager, Treasury
Job ID: 12950
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Finance
Department: Treasury - 4123


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

2+ years in Treasury or Corporate Finance, Exposure to Investments and Capital Markets Financing, advanced degree preferred.

Responsibilities will include, but are not limited to, the following:

- Responsible for management of treasury activities including cash management, managing short-term investments and trade settlement procedures, maintenance of banking relationships and debt compliance, manage working capital needs, and monitoring market activity.
- Support the Assistant Treasurer with of the investment of $2.5B+ of cash, cash equivalents, and marketable securities within the Company’s approved investment policy including setting investment strategy and all analytical support in investment and liquidity management – asset allocation, manager selection, performance tracking, investment guidelines and compliance.
- Assist with selection and management of external investment managers to ensure high level of performance and recommend investment portfolio strategies for maximum returns.
- Monitor, measure and report on world-wide cash investment and marketable securities to diverse audience of internal and external parties. Ensure proper measurement and reporting of the individual and consolidated portfolios’ risk/return characteristics. Write and update reports per customer requirements.
- Provide financial analysis, modeling, and recommendations for cash management and corporate finance projects (capital structure, debt, inter-company funding requirements, dividend policy, rating agency relationships, and investment policy and strategy).
- Assume ownership of Treasury’s long-term cash forecast model
- Accurately forecast interest income and expense, providing timely updates to appropriate stakeholders
- Ensure the accuracy of public external reports (10Q, 10K) with regards to investments, debt, and interest income/expense
- Assist department with analysis and presentations for the Board of Directors on matters of corporate finance, investments and external financing.
- Ensure adequate liquidity across over 40 legal entities, managing the optimal working capital mix as to maximize the return on working capital
- Assist department w/ research, planning, negotiation and execution of all external financing including, but not limited to equity, public debentures, convertible bonds, syndicated loan facilities, and private financing.


Skills/Knowledge Required:

- A working knowledge of corporate finance, fixed income investing and external capital markets.
- 2+ years experience in Treasury or Corporate Finance; Pharma industry experience a plus.
- Advanced degree in finance or MBA preferred
- Demonstrated intellectual curiosity and superior academic performance
- Intermediate/advanced spreadsheet modeling skills
- Familiarity with investment reporting and tracking software (Bloomberg, Clearwater, etc.)
- A willingness to back-up other Treasury functions (e.g. FX, Cash Management) as required.
- Ability to work as a team player in a very fast-paced environment

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Associate-Manager%2C-Treasury-Job-NJ-07922/1774221/177422117742212012-06-14Celgene CorporationFinancefull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Senior Director, IT Business Partnership (Global Tech Ops Systems)
Job ID: 12965
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: IT – Global Business Partner - 4168


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Bachelor’s degree required. Advanced degree preferred.

Minimum 12 years in multiple organizational contexts, linking technology solutions to business needs in biopharmaceutical industry desired.


Skills/Knowledge Required:

- Greater than 12 years experience in multiple organizational contexts, linking technology to business needs in biopharmaceutical industry.
- Deep knowledge of regulatory requirements in the areas of Good Manufacturing Process (GMP) and Risk Evaluation and Mitigation Strategy (REMS).
- Understanding of regulatory requirements and the role technology plays in satisfying those requirements is essential to this position.
- Experience in information technology preferably within a pharmaceutical technical operations environment. Experience should range from enterprise resource planning applications (Oracle, SAP) and risk management software to GxP document management, GxP learning management, quality management, etc.
- Thorough understanding of best practices in SDLC and ITIL.
- Demonstrated effective leadership skills in building high performance teams.
- Strong understanding of IT disaster recovery solutions and planning
- Understanding of financial concepts, TCO, and ROI
- Excellent skills in change management, staff mentoring, performance evaluation, life-long learning, and diagnosis of sources of problems in both technology and business processes.
- Ability to work strategically and independently with internal and external groups on multiple projects.
- Must be client service-driven with excellent relationship management and analytical skills.
- Flexible, adaptable and hands-on approach necessary.
- Experience in implementing IT strategies and a technology roadmap for multiple clients
- Exceptional communication and leadership skills as evidenced in small and large organizations.

The Sr. Director of IT Business Partnership plays a key role in Information Technology at Celgene bearing responsibility for capturing demand originating in the Technical Operations business function and translating that demand into solutions. This includes developing technology roadmaps that align to the business strategy; developing business case, budget and business requirements for project initiation, evaluation and selection of solutions in partnership with the business stakeholders; as well as defining service level requirements and agreements between IT and the business. Celgene IT is committed to achieving excellence as measured (in part) by their effectiveness in supporting business functions and related business processes across the company. The Sr. Director must excel at working in a collaborative, diverse, complex, resource-constrained environment and be able to lead decision-making processes that involve multiple constituencies and constraints.


Responsibilities will include, but are not limited to the following:

- Act as the senior advisor to the business and IT executive management on the technology needs of the Technical Operations business, specifically around Commercial Manufacturing, Supply Chain Planning and execution, Investigational Material Supply Chain and Customer Care.
- Function as the liaison and key contact point between the business and IT
- Work with senior management in Technical Operations to develop and support strategies for business process improvements through information systems automation.
- Develop technology centric roadmaps that align with the strategic business goals within Technical Operations.
- Develop detailed business requirements for new projects initiated with the business.
- Prepare detailed business case documentation with focus on clear defined scope, stakeholder identification, organizational impact, cost benefit analysis and ROI, risk management and related dependencies.
- Define service level management scope and process with IT groups and/or vendor managed services i.e. Service Level Agreements (SLA’s), Disaster Recovery/Service Continuity etc.
- Lead the business in User Acceptance activities for project implementation.
- Participate in high-level strategic communications with the business leadership team
- Work with the Head of IT Business Partnership and peers in IT to develop strategies for internal department improvements.
- Be a source of business function knowledge for IT groups.
- Lead Governance definition and implementation working together with relevant business owners.
- Identify key technology trends and how new technologies might be leveraged to provide better solutions to the business.
- Lead a matrixed organization composed of both direct reports and groups of indirect reports located remotely around the globe that are responsible for delivering cost effective, innovative, and stable solutions that meet needs of our customers globally.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Senior-Director%2C-IT-Business-Partnership-%28Global-Tech-Ops-Systems%29-Job-NJ-07922/1780062/178006217800622012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Senior Manager, Pharmaceutical Development
Job ID: 12969
Location: Basking Ridge, NJ -110
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Drug Product Development - 3260


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

A Ph.D. in pharmaceutical science, chemical engineering, or related discipline with a minimum of 7-10 years of relevant industry experience or a MS or BS degree with 12- 14 years in pharmaceutical development.

Summary:

The primary role of the Senior Manager of Pharmaceutical Development will be to lead and coordinate internal and outsourced development of drug product formulations and manufacturing processes for Celgene pipeline products. This position will play a central role in the planning and execution of projects to advance the development of the Company’s product candidates. Products may be for Pre-Clinical, investigational use, clinical supplies, or commercial sale.

Roles & Responsibilities:

The primary role of this position will be to lead the development of products that reliably meet all regulatory and corporate requirements. This position is responsible for the technical direction of dosage form development projects from concept development through full-scale production. A thorough understanding of drug development technologies and downstream implications for development strategies is required. Multiple development programs will be operational at the same time therefore time management and the ability to multitask are considered critical job responsibilities. Approximately 70% of the actual development work will be performed by contract research and manufacturing organizations under the day to day direction of this position. Therefore, strong communication skills and the ability to appropriately represent Celgene to third party contractors are required. Specific responsibilities of this position will include:

- Define, develop and implement pharmaceutical product strategies based on scientific, technical, regulatory, and market place needs
- Develop project plans which define timing, resources and overall project costs
- Evaluate, recommend and oversee contract research and manufacturing organizations capable of providing the technical services required
- Act as the primary contact/representative to internal and external clients for dosage form development on specified projects
- Direct, coordinate, and execute product, process optimization, and validation studies using Quality by Design principles
- Lead multifunctional technical development teams on specified projects
- Lead the resolution of technical issues related to development and commercialized products
- Coordination of project activities with other internal functions such as Regulatory Affairs, Quality Assurance, Analytical R&D, Preclinical and Clinical functions, Sales/Marketing, etc.
- Author, review and approve CMC related documentation as required for the market application
- Interact with FDA/EMA regulatory authorities pre- and post-submission as required
- Define the pharmaceutical product requirements with a primary focus on drug product dosage form/delivery systems while providing input into requirements for drug substance, and analytical methods
- Contribute to department goals

Qualifications:

- Broad based knowledge of pharmaceutical development and manufacturing.
- Background in drug development with demonstrated expertise in solid dosage forms, and drug delivery technologies. Should be familiar with semi-solid, and liquid dosage forms.
- Understanding of drug substance characterization and impact on drug product development
- Ability to evaluate, and share data across functions for evidence based decision making
- Proven ability in pharmaceutical development and process improvements
- Development and validation of manufacturing processes
- Lead, and participate in technology transfer activities
- Strong communications skills with a team oriented approach
- Project Management skills including the ability to prioritize, schedule and manage multiple projects and resources simultaneously
- Working knowledge of international GMP requirements and quality systems.
- Working knowledge of current regulatory guidelines (EMA and FDA).

This individual must be highly motivated and enjoy working in a fast paced, challenging matrix environment. The individual should be able to interact cross-functionally at all levels internally within Celgene, and externally with consultants/contractors and business partners. The candidate must be flexible relative to responsibilities. Approximately 30% to 40% travel, both domestic and international, is required.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Basking-Ridge-Senior-Manager%2C-Pharmaceutical-Development-Job-NJ-07920/1782210/178221017822102012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSBasking Ridge, NJ, USJob Title: Senior IT Administrator
Job ID: 12972
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: ITGOS Technology - 4163


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Technical degree preferred; 7-10 years’ full-time systems administration experience in a corporate environment.

The responsibilities of this position include, but are not limited to, supporting the server infrastructure with specific emphasis on building and delivering systems to the business and diagnosing issues with applications.The Lead IT Administrator will have the ability to lead projects, research, design and implement hardware and software solutions.

Responsibilities will also include, but are not limited to, the following:

- Installs and configures Linux and Windows operating systems on newly acquired hardware.
- Configure new servers while documenting the implementation.
- Follow standard operating procedures while maintaining validated servers.
- Installation of off-the-shelf applications and document the installation procedures.
- Provide Customer support via telephone, e-mail, and other tools.
- Provide timely status updates to Americas’ Operations manager and other IT management
- Perform other job related duties as required
- Lead other systems engineers and systems analysts
- Be responsible for storage area network design/implementation/management
- Resolving high level technical issues when needed


Skills/Knowledge Required:

- 5+ years Red Hat Enterprise Linux experience
- Red Hat certification is preferred
- Windows 2003/2008 experience desired, MCSE
- High Availability and failover scenarios, load balanced environments.
- Familiarity with databases and web programming languages
- IBM Blade Server administration experience strongly desired.
- Strong working knowledge of IBM storage environments (SAN,NAS)
- Excellent communication and organizations skills are required
- On-call support on some nights and weekends and carrying a cell phone are required. Occasional late-night maintenance, alone at the corporate facilities, is required.
- Must be able to physically lift and move computers and printers.
- Some travel may be required.

Education/Experience:

- Experience with VMware is preferred
- Pharmaceutical background preferred. Understanding of the CFR Part 11 and Sarbanes-Oxley regulatory requirements and experience with processes and procedures to apply and administer these and other necessary regulatory requirements in an operational environment.
- Technical degree preferred in Computer Science, Information Systems,
- Solid experience with multi-server environment/ deployments
- Active Directory experience strongly desired.
- Demonstrated ability in staying abreast of technical developments in the industry and aligning them with strategic company objectives.
- Organizational "Fit" Considerations: The candidate must be flexible to take on different tasks at short notice and have the ability to function in cross-functional team setup that consists of different disciplines. Prospective candidate must be able to work in a fast paced environment.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Senior-IT-Administrator-Job-NJ-07922/1784021/178402117840212012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBerkeley Heights, NJ, USMedical Affairs
Montreal, Quebec, Canada

MD, DO, PharmD, MSN, PhD or MS in a scientific discipline highly desired. Minimum of 5 years experience in Medical Affairs and/or drug development supporting specialty care compounds/products required. Clinical/protocol experience needed. Dermatology and/or rheumatology experience highly desirable. CORE GLOBAL COMPETENCIES The Regional Medical Liaison (RML) is a member of a field-based team of scientists who function as an extension of the Medical Affairs organization. RMLs are responsible for developing and enhancing professional relationships with medical thought leaders involved in various phases of product development. RMLs provide medical information through scientific exchange in a fair-balanced manner and provide clinical/scientific support for Celgene and the Medical Affairs department at the direction of Medical Affairs management. This is a field-based position and requires professionals with established creditability to interact with thought leaders and centers of excellence. The position involves travel of more than 50%. Responsibilities will also include, but are not limited to, the following: • Identify, develop and maintain collaborative relationships with current and future Key Opinion Leaders (KOLs) and healthcare stakeholders in disease states of strategic importance to Celgene • Provide clinical presentations and information in response to unsolicited questions (as appropriate) in academic, community and healthcare provider setting in both group and one-on-one settings • Collaborate with the Clinical organization to enhance patient enrolment in Celgene-sponsored clinical trials by identifying appropriate trial sites and interacting with investigators in ongoing studies • Act as a primary liaison to investigators interested in developing and performing investigator initiated research. • Develop and execute territory plans in alignment with regional and national plans of action (POAs) • Assist in the reconnaissance of Market landscape determination and competitive intelligence including therapeutic trends and unmet needs within the appropriate disease states and marketplace and provide timely feedback/information on emerging clinical/scientific information and opportunities to internal stakeholders • Provide scientific support at medical congresses Skills/Knowledge Required: • MD, DO, Pham D, MSN or PhD highly desirable • 3-5 years clinical or medical affairs experience in inflammation/immunology therapeutic area(s) • Current working knowledge of local legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health-care professionals • Ability to effectively partner and maintain relationships within the medical community • Excellent communication, presentation and time management skills REGIONAL COMPETENCIES or PROVISIOINS • Fluency in English and French is required..]]>http://jobs.celgene.com/job/Montreal-Regional-Medical-Liaison%2C-Inflammation-&-Immunology-Eastern-Canada-Job/1784023/178402317840232012-06-14Celgene CorporationMedical Affairsfull-timeUSDstarting0BSMontreal, Quebec, CanadaJob Title: Associate Director (MD), Clinical Pharmacology
Job ID: 12975
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Research
Department: Translational Dev - Clin Pharm - 3613


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

MD (Board Eligible) with 3+ years of relevant clinical research experience is required, preferable in human pharmacology.

Scope of Responsibilities:

Assume (with guidance) strategic responsibility for the Clinical Pharmacology components of development from a drug candidate’s nomination forward through its lifecycle management post approval.

- Materially contribute to the thinking around compound development (e.g., generate an Early Drug Development Plan before compound enters Phase I, revise and update later plans as appropriate).
- Demonstrate ability to contribute to filings and dossiers across regulatory regions, maintain currency of program requirements (e.g., safety updates, annual reports) and negotiate with functional counterparts from regulatory jurisdictions.

Develop external awareness and liaisons with external scientific personnel to advance drug development. Exhibit scientific leadership in the application of clinical pharmacology (including new methodologies) to drug development. For example:

- Contribute to the design, planning and execution of Clinical Pharmacology studies and their quality conduct through completion of the study report.
- Establish proof of activity and characterization of the pharmacodynamics in the clinic, using appropriate endpoints or biomarkers (including pharmacogenomics) in collaboration with Discovery, Translational Medicine and Clinical Departments.
Embrace continuous improvement (e.g., leading / participating in initiatives to improve outputs and processes) in the company.
- Contribute to the design and execution of pharmacodynamic (including monitoring or elucidating for non-therapeutic activity) and specialized methodologies (such as PET and other imaging scans) throughout the product development process as appropriate.
- Share responsibility for the determination of the PK/PD correlation to aid in Phase II dose selection with the Clinical Pharmacokineticist. Assist with design and interpretation of PK models.

Effectively represent Clinical Pharmacology as a representative in both intra- and extra-departmental activities (e.g., Project Team)

- Share cross-functional responsibility for the characterization of the safety, tolerance, and pharmacokinetics in healthy volunteers and/or patients, (FTIH single and multiple doses). Demonstrate leadership in identifying and addressing cross-functional issues.

Show potential to direct others in the realms of science and operations associated with drug development in clinical pharmacology. The position is initially designed for the level of an individual contributor to the organization.

Education / Experience:

Possess a MD with 3+ years of relevant clinical research experience is required, preferable in human pharmacology. Demonstrate a detailed knowledge of drug development, basic pharmacology, clinical research concepts and practices, pharmacodynamics and clinical pharmacokinetics, including:

- Knowledge of FDA and international (e.g., ICH) regulations regarding conduct of clinical studies (GCP) required. Experience negotiating with regulators a plus.
- Experience within oncology or immunology clinical research is a plus.
- Have a general knowledge of data processing methods and statistical analyses are preferred, with computer literacy (e.g., facility with Microsoft Office) a must.

Communication & Interpersonal Skills:

- Exhibit well developed oral communication and interpersonal skills as well as excellent writing skills.
- Demonstrate ability and willingness to work within a matrix environment and ability to function as representative on project teams are required.

Strategic & Operational Skills:

- Demonstrate excellent analytical and problem solving skills.
- Demonstrate ability to generate innovative ideas and be able to conceptualize bridging discovery and developmental animal and human models, biomarkers, and human pharmacology techniques.
- Exhibit strong project and time management skills so that tight deadlines can be met.
- Ability to differentiate critical events at study sites, prioritize options and propose solutions as well as able to communicate effectively these issues to the appropriate parties.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Associate-Director%2C-Clinical-Pharmacology-Job-NJ-07901/1786244/178624417862442012-06-14Celgene CorporationResearchfull-timeUSDstarting0BSSummit, NJ, USIT
Neuchatel, Switzerland

PREREQUISITES

5+ years of experience in all aspects of IT Infrastructure and SAN storage administration & management

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

- Perform storage implementations, performance analysis and optimization, storage systems monitoring, problem resolution, upgrade planning and execution, and process creation and documentation in accordance with Pharma and regulatory compliance guidance.
- Participate in the design and build of Storage solutions for Windows & Linux Servers, VMware Infrastructure and Network Attached Storage solutions based on business requirements and operational considerations.
- Administer the SAN Infrastructure and perform periodic reviews, including HBA firmware levels, switch firmware and storage firmware to ensure compliance with best practices.
- Contribute to problem resolution for issues reported by clients or peers, including escalation to vendors and IT management.
- Acts as a self-directed and self-motivated facilitator to lead peers through effort, example and collaboration.
- Writing formal “after resolution” report for production problems and providing feedback on architecture improvements
- Follow standard operating procedures while maintaining validated systems.
- Oversee the maintenance / monitoring of systems within the environment to ensure optimal performance, to determine system upgrade/replacement schedules.
- Participate in evaluation of storage hardware and software solutions. Research solutions and formulate recommendations.
- Provide timely status updates to IT management
- Contribute and participate to Celgene worldwide Infrastructure projects.

Skills/Knowledge Required:

Working Experience & Education:

- Candidates must have a technical degree in Computer Science, Information Systems, Telecommunications, Electronics or equivalent experience.
- 5+ years of relevant experience in IT Storage
- Training on storage technology is required
- Prior experience in an International organization is a must
- Experience working in a regulated environment with pre-defined process and change management is desired
- Experience designing/implementing Storage in a redundant Cisco switched fabric environment with at least 100 hosts is a must
- 3+ years of experience with the IBM and EMC Servers and Storage portfolio is desired
- 5+ years of Storage and Storage virtualization and administration experience is desired

Skills / Knowledge:

- Strong written, oral and interpersonal communication skills in English is required
- Strong written, oral and interpersonal communication skills in French is desired
- Flexible to take on different tasks at short notice
- Ability to function in cross-functional team, inside and outside of IT.
- Good project management skills & priorities setting.
- Excellent communication skills & team spirit
- Ability to work independently, and in a fast-paced environment
- Hands-on experience with IBM and Netapp storage environments (SAN, NAS)
- Hands-on experience with Cisco SAN fabric environments (MDS, Nexus)
- Good knowledge of VMware, Linux and Microsoft Windows 2003/2008 operating systems, Active Directory, Exchange and related technologies in an international environment is a plus
- General understanding of Networking and Network Security
- Solid communication and Project Management skills.]]>http://jobs.celgene.com/job/Neuchatel-Senior-IT-Storage-Specialist-Job/1788315/178831517883152012-06-14Celgene CorporationITfull-timeUSDstarting0BSNeuchatel, SwitzerlandRegulatory Affairs
Neuchatel, Switzerland

PREREQUISITES

Min1-2 year working experience in Clinical Trials in Europe

Ideally: strong working knowledge of European Clinical Trial Applications and procedures

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

- Plan, prepare, co-ordinate & submit CTAs including: Communication with Regulatory Responsible Person, Affiliates, Study Team members &, CROs to gather input and collect appropriate documentation/information.
- Initiate response preparation to Health Authorities questions in conjunction with Regulatory Responsible and study team, where applicable
- Maintain the CTA during its life cycle (i.e. amendments, end of trial declaration & Final Study Reports,)
- Participate in Study Team meetings to provide the team with procedural regulatory advice and input
- Keep a breast of new developments in European legislation and guidelines applicable to clinical trials
- Create and/or maintain a CTA knowledge base with up to date information on ongoing and passed trials (countries benchmarking, list of questions, submissions requirements, etc…). Share this knowledge with the relevant parties
- Ensure consistent approach across all projects through close interaction with peers as well as Regulatory Responsibles and Managers.
- Track CTA activities including timelines and milestones. Communicate the CTA submissions and approvals to the relevant parties
- QC the CTA package and oversees dispatch together with Submission Specialist
- Acquire and maintain excellent knowledge and observance of SOPs/WPs as well as maintaining relevant SOPs and WPs for clinical trials in the light of evolving practice

General:

- Assist and support Regulatory team on any other activities related to the above
- Other duties related to the above within Celgene as a whole, as assigned $

Core Competencies:

- Technical Competence: strong knowledge of EU Clinical Trial Directive and respective guidance documents as well as ICH guidelines.
- Teamwork: work effectively to share responsibility as a team member in a cross-functional team, matrix-based environment. Openness to learn from more experienced staff and to share own experience
- Planning, Coordination and Organisation: excellent project planning skills; pay attention to details and demonstrate commitment to deliver high quality work to agreed timelines
- Communication and Negotiation Skills: able to communicate proactively and effectively in a multi-cultural, multi-functional environment. Able to interact effectively with individuals or groups who may have different interests or goals to achieve team objective

Skills/Knowledge Required:

- Excellent project planning, administrative and organizational skills; attention to detail and timelines
- Ability to prioritize tasks, to work independently on multiple tasks in parallel and under time pressure
- Flexible and adaptable to changing project priorities and work assignments
- Good oral and written communication skills
- Fluency in written and spoken English, knowledge of other languages an advantage
- Good computer skills to include: MS Word, Excel and PowerPoint
- 1-2 year working experience in Clinical Trial application and precedures in Europe]]>http://jobs.celgene.com/job/Neuchatel-Senior-Specialist%2C-Regulatory-Operations-Europe-%28Clinical-Trials%29-Job/1788317/178831717883172012-06-14Celgene CorporationRegulatory Affairsfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Sr. Compliance Manager, Global Regulatory CMC
Job ID: 12888
Location: Basking Ridge, NJ -110
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Global Regulatory CMC - 3258


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BS/BA degree in Scientific Discipline (Masters or higher preferred) with
6-8 years in the pharmaceutical industry or in CRO. CMC experience a highly desirable.

Responsibilities will include, but are not limited to, the following:

1. Assure the accuracy of regulatory submissions by reviewing CMC documents against technical source documents (technical reports, validation reports, Master Batch Records, etc.).
2. Interface with Regulatory Affairs (North America, Europe, International, country RA Managers and CROs), Quality Operations (North America and International) and Investigator Material Supply Chain to implement and maintain systems for tracking of global regulatory approvals (original CTA/INDs, amendments, original NDA/MAAs and post approval variations).
3. Liaise with Quality Operations to review Master Batch Record updates in accordance with approved NDA/MAA globally.
4. Establish intelligence database containing regulatory CMC requirements and timelines for global submissions (original IND/CTAs, amendments, original NDA/MAAs, supplements/variations, annual reports and renewals).
5. Develop Regulatory CMC SOPs, work practices and best practices as needed.
6. Coordinate Regulatory CMC comments for inter-departmental SOPs/practices that involve Reg CMC as a stake holder.
7. Supervise a direct report of Regulatory Compliance position
8. With supervision, prepare CMC submission documents and coordinate supporting activities as required.
9. Interface with Regulatory Affairs, coordinate CMC comments for draft regulatory guidance documents.


Skills/Knowledge Required:

- In-depth understanding of quality and compliance aspects of pharmaceutical development and manufacturing.
- Knowledge of FDA, EMEA and/or ICH guidelines
- Good understanding of either the drug development process or commercial manufacturing activities
- Experience with CMC regulatory documents preferred
- Detail oriented. Strong organization skills.
- Ability to work on complex projects and within cross-functional teams

Excellent grammar and communication skills, both written and oral

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Basking-Ridge-Sr_-Compliance-Manager%2C-Global-Regulatory-CMC-Job-NJ-07920/1788318/178831817883182012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSBasking Ridge, NJ, USJob Title: Biomarker Development & Clinical Assay Qualification Lab Head
Job ID: 12988
Location: San Francisco, CA
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Research
Department: Translational Medicine - 3268


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequistes:

- MD/PhD with human molecular pathology expertise orPh.D. in biological/medical sciences, with extensive training in biomarker assay development and 10+ years industry experience
- Thorough knowledge of the drug discovery process, including preclinical research, early and late clinical development
- Demonstrated success in impacting the direction of drug development through implementation of translational science research strategies
- Familiarity with regulatory requirements of assay development, optimization, validation, and transfer for conduct by a Clinical Laboratory Improvement Amendments (CLIA) approved lab.
- Management experience in industry with the ability to set priorities, direct projects, budget and personnel
- Highly effective teamwork and interpersonal skills and the ability to work across numerous scientific disciplines
- Experience in establishing laboratory processes, writing SOPs, and managing project flow/prioritization in the laboratory
- Ability to provide focus and clarity; able to handle confidential information and material appropriately.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Strategic thinker who can balance near term objectives with long term goals and outcomes, evaluate new technology and develop effective solutions through an integrated multi-disciplined decision-making approach.
- Knowledge of GLP regulations and certification standards
- Broad understanding of cellular, molecular and genome based single and multiplex assay platforms and analyses software
- Understanding of emerging technologies and platforms desirable
- Demonstrated experience in working with Central Labs/Vendors and/or companion diagnostic companies for assay acquisition, transfer and utilization in clinical trials


Summary

We seek a PhD or MD/PhD with human molecular pathology expertise, significant scientific research experience and extensive training in companion diagnostic development and biomarker assay development to join our Translational Medicine department. The candidate should be highly motivated, organized and detail-oriented, supporting efforts to discover biomarkers and molecular signatures predictive of patient response to cancer therapy. This individual will be responsible for overseeing development and qualification of assays to be used in oncology clinical trials and will manage and supervise scientific, administrative, and technical activities related to the Biomarker Development and Clinical Assay Qualification Laboratory. Knowledge and proven track record of novel assay development required. Expertise in OMICs technologies, companion diagnostic strategies and immunoassays required. He/she will interact closely with discovery and clinical project teams, outside collaborators, commercial vendors and bioinformatics colleagues.

Responsibilities will include, but are not limited to, the following:

- Establish and manage a laboratory function focused on development of “fit for purpose” biomarker assays.
- Providing guidance to project teams on companion diagnostic development and biomarker development and translational operations regarding best practices on sample collection, processing, site training and analysis of clinical samples.
- Essential member of Translational Development Leadership Team, Companion Diagnostic Cross Functional Committee member and involved with Global Project Teams.
- Develop strategy, vision and functional SOPs for the laboratory function
- Extensive knowledge and hands on technical experience in assay development using human tissue.
- Serve as resident expert in R&D considerations for companion diagnostic and biomarker assay development.
- Direct Ph.D and non-Ph.D scientific staff and provide oversight of experimental design and interpretation of experimental data. .
- Responsible for prioritization, design, logistics, resource allocation, schedules, identified critical support needs, and other details as may be necessary in order for staff to implement the program(s).
- Collaborating with internal Celgene scientists and outside investigators/vendors.
- Responsible for development of research staff, through instruction, coaching and guidance. Capable of identifying training needs in others and providing support and assistance in their career development.
- Excellent verbal and written communication skills.
- Establishing and maintaining a tissue bank

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/San-Francisco-Biomarker-Development-&-Clinical-Assay-Qualification-Lab-Head-Job-CA-94101/1791349/179134917913492012-06-14Celgene CorporationResearchfull-timeUSDstarting0BSSan Francisco, CA, USJob Title: Validation Scientist
Job ID: 12997
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Validations - 1119


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a Bachelors degree in Science or Engineering from an accredited college or university with a minimum of 4 years related experience in a regulated industry, preferably in a pharmaceutical environment.
- An equivalent combination of education, experience and training may substitute.

POSITION SUMMARY

The Validation Scientist develops all qualification and Technical Services approaches (risk/science based) and provides the scientific rationale documented in protocols (including conducting research into industry standards/FDA guidelines), executes validation studies, performs data analysis and writes protocol summaries and technical reports.

ESSENTIAL FUNCTIONS

- Operate instrumentation; perform protocol execution and validation activities, including collection of samples associated with qualification. In coordination with Production and Validation management, schedule equipment times, prepare test equipment and assure that testing is completed according to approved validation protocols.
- Participate in project teams, while managing timelines, resources and communications specific to individual tasks.
- Perform data analysis (including statistical probability) and prepare written reports/summaries from validation studies.
- Develop the qualification approach and provide the scientific rationale, generate validation protocols and assist other department members in conducting industry and regulatory research. Generate project schedules and manage qualification activities according to site objectives and timelines. Collaborate with applicable departments to ensure project activities are completed as scheduled.
- Calibrate or verify calibration of critical processes instrumentation and equipment and prepare documentation of the calibrations related to validation requirements in protocols.
- Cross check and verify validation data prepared by others during the regular peer review process. Write and revise drafts of department applicable SOPs.
- Participate and defend validation approaches in regulatory audits.
- Execute change controls and perform validation non-conformance investigations associated with qualification activities.
- Perform daily job functions with minimal guidance and supervision.
- Primary responsibilities will specialize in, and/or the following: computerized systems, equipment/facilities/utilities and technical services (PV/CV related).
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Validation-Scientist-Job-AZ-85001/1792520/179252017925202012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USQuality Assurance
Neuchatel, Switzerland

PREREQUISITES

BSc/MSc in science or medically related field or other relevant education in scientific field

+3 - 5 years Quality Control and/or Quality Assurance experience in a pharmaceutical company or other related industry

Proven experience in handling deviation, change control and CAPA

Exposure to health authority inspection expected

Duties and Responsibilities

- A) Provides active support to assigned vendors QA compliance tasks (non exhaustive list) through a close partnership with vendor’s representatives:
- Deviations/OOS and CAPAs related to events occurring at manufacturing/testing sites: review/assessment (in collaboration with other internal experts as appropriate), feedback to vendor, communication to appropriate Celgene functions, follow-up.
- Product investigations (e.g. complaints): review/assessment, coordination of investigation with vendor, liaison with appropriate Celgene functions, follow-up.
- Change Control events from or to the vendor
- Master Batch Records (MBR) and associated production documentation: review/coordination of review (in collaboration with other internal experts as appropriate), approval, liaison with vendor, communication to appropriate Celgene functions.
- Annual Product Review (APR), Product Quality Review (PQR): compilation and review of data supplied by the vendor and appropriate Celgene departments, according to Celgene and Swiss-, EMEA- FDA- requirements; CAPAs follow-up, liaison with vendor as appropriate.
- QA tasks triggered by regulatory submissions: assessment of requests/needs, liaison with vendor and Celgene departments as appropriate, preparation of necessary QA documentation.
- Audits and inspections: coordination of vendor actions related to the preparation phase
- Compliance assessment of batches prior to release, liaison with vendor QP and Celgene QA functions as appropriate.
- Quality management: coordination of periodic QA meetings with vendor reps as assigned, advice/identification of areas for improvement
- B) Handles Product Quality Complaints (PQC) for products / areas as assigned: assessment, trending, investigation tasks coordination
- C) Reviews and updates procedures for the Quality Management System of Celgene International as per process ownerships and business needs.
- D) Participates to Celgene audits and visits to external manufacturers as assigned.
- E) Acts as QA representative during authorities inspections and acts as Subject Matter Expert for relevant topics.
- F) Assists in the improvement of existing processes and the development of new processes or sub-processes related to the QMS of Celgene International Sàrl as assigned.
- G) Participates to international working groups pertaining to assigned quality topics.

Skills/Knowledge Required:

- At least 3 - 5 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry.
- BSc/MSc or equivalent education in Science, or related field.
- Thorough understanding of cGMPs and EU and FDA regulatory requirements.
- Knowledge of aseptic manufacturing processes and related QC testing.
- Understanding of solid oral dosage forms and API manufacturing processes and QC testing.
- Ability to work independently, yet effectively in a team environment.
- Ability to focus attention to details.
- Excellent investigational and QA problem solving skills.
- Good written & oral communication skills in English a must.
- Knowledge of most common office software (Microsoft Office).]]>http://jobs.celgene.com/job/Neuchatel-Assoc_-Manager%2C-QA-Compliance-Job/1792522/179252217925222012-06-14Celgene CorporationQuality Assurancefull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Compounder - 1st Shift
Job ID: 12998
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Compounding - 1116


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a High School diploma or equivalent, AA degree preferred, with a minimum of 2 years related experience in a regulated setting, preferably in a manufacturing environment.
- An equivalent combination of education, experience and training may substitute.
- Must have good understanding of cGMP requirements.
- Must have a proven technical understanding of processes system operations, equipment and problem solving.

POSITION SUMMARY

The Manufacturing Operator, NAB Compounding, is responsible for the precise compounding of nab (nanotechnology albumin bound) and cytotoxic/antineoplastic products in accordance with batch record specifications. Works in a compliant, efficient, effective and safe manner and effectively manages resources to maintain production goals and efficiencies.

ESSENTIAL FUNCTIONS

- Ensures proper systems, equipment, materials, and other resources are in place to meet production demands through hands-on involvement and liaison with supervision.
- Ensures area/facility cleanliness, equipment cleanliness, and proper operation and functionality of all equipment, hardware, tanks, and tools within the compounding facility.
- Compounds products according to specifications and in complete accordance with all cGMP, SOPs, and Batch Records.
- Ensures all documentation is correct and addresses procedural /documentation errors expeditiously and effectively.
- Works closely with material and warehouse personnel to ensure batch materials and equipment are available to meet production timelines.
- Works with maintenance to minimize downtime, coordinate work scheduling, and ensure equipment is maintained in proper operating and validated conditions.
- Ensures proper operational supplies and consumables are on hand to meet production requirements.
- Complies with and enforces all hazardous material handling and safety requirements.
- Assists with process improvement projects and programs.
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Compounder-1st-Shift-Job-AZ-85001/1795115/179511517951152012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Security Specialist - Analyst II, IT
Job ID: 13000
Location: San Diego, CA
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: ITGOS Security - 4164


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Bachelor's degree in a technical discipline or equivalent plus a minimum of 7 years of network, computer, or other technical experience, including 3 years of information security experience required.

Reporting to Celgene's Information Security Director the Security Analyst position is part of an overall team responsible for enterprise-wide oversight and coordination of information technology security efforts to reduce risks, respond to incidents and limit exposure to liability and risk with regard to IT systems, networks and applications. This position utilizes strong policy and process knowledge as well as skills and expertise with a variety of technologies. It also involves interaction with numerous other departments and business functions.

Responsibilities will include, but are not limited to, the following:

- Accountable as part of a team for implementation of the Information Security program for Celgene Corporation.
- Stay current on changes in the Pharmaceutical industry, Celgenes products and services, and information security terms, concepts, practices, and policies, as well as changes in the regulatory and audit requirements with respect to information security and privacy on a Global basis.
- Ability to identify significant information security risks, execute design and implementation of strategies and programs to prevent or reduce the loss of organizational assets.
- Address and/or escalate information security issues and concerns to the Information Security Director – Celgene.
- Remain current in state-of-the-art technology solutions and innovative information security management techniques to safeguard organizational assets.
- Communicate effectively with clients to address complex information security issues with limited assistance.
- Support information security awareness throughout the organization to educate on information and security risks and solutions.
- Prepare and review activity reports as requested by management.
- Develop close working relationships with management, company peers, and industry counterparts to ensure alignment of company goals with current information security industry and regulatory trends.
- Keep Information Security management apprised on the status of information security issues and initiatives.
- Perform other related duties as assigned.

Education/Experience/Skills

- Bachelor's degree in a technical discipline or equivalent plus a minimum of 7 years of network, computer, or other technical experience, including 3 or more years of information security experience required.
- Well versed in information security concepts (e.g. defense in depth, separation of duties, control environments, malicious software, security awareness etc.).
- Working knowledge of IT technologies (for example, operating systems, network protocols, information security management systems etc.)
- Working knowledge of information security technologies (e.g. firewalls, proxy servers, IP/load balancers, wireless networks, VPN and cloud)
- Working experience with security monitoring solutions (e.g. IPS, NAC, DLP, SIEM etc.)
- Strong working experience in intrusion monitoring, incident response and forensics
- Experience in role based application and infrastructure security (e.g. Active Directory / Identity Management / LDAP etc.)
- Strong demonstrated knowledge of industry best practices in regard to network security (e.g. NIST, SANS, NSA etc.)
- Working knowledge of various regulatory and broad security best practice standards and guidelines (e.g. ISO 27002, PCI, SOX, EU Privacy, HIPAA, Safe Harbor etc.)
- Demonstrated experience with technology and methodologies standard to network engineering
- Proficient at multitasking and prioritizing in a fast-paced environment.
- Ability to communicate verbally and in written forms in a professional manner.
- Ability to plan and organize work schedule for self.
- Ability to work as both a team member and leader, meet team schedules, and contribute to the team's goals and objectives.
- Provide assistance to technical and management personnel as required.
- Actively participate in meetings and provide constructive input.
- Facilitate when requested, meetings, establish agendas, and document follow-up actions as needed.
- Experience working in a global (multinational) environment is required
- Experience in the Pharmaceutical industry is a plus

Professional Certifications

Certified Information Systems Security Professional (CISSP), Global Information Assurance Certification (GIAC), or applicable technical certifications a plus.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/San-Diego-Analyst-II%2C-IT-%28Security%29-Job-CA-92101/1797213/179721317972132012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSSan Diego, CA, USJob Title: Associate Director, Clinical QA & Compliance
Job ID: 13005
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Clinical Quality - 3610


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

������ B.S. or B.S./M.S. in Chemistry, Biology, or heath related fields

������ 5 plus years direct QA/HA experience, including 10 years clinical/Industry/HA experience

Responsibilities:

1. Contributes to the strategic planning, assignment, and performs/reports GCP audits of (Phase IIV)

CRD studies, eg, Clinical investigator sites, Vendors/CROs, internal system/processes and

Clinical documents or data, including CAP evaluation and follow up

2. Appropriately escalates any compliance issues to relevant management personnel

3. Leads/performs for‐cause audits or other high profile audits, projects and/or special

investigations to evaluate noncompliance, root cause identification, and reports results to

management

4. Contributes to the identification and communication of lessons learned from audits and

inspections and provides expert advice/information to CQA and CRD staff

5. Evaluates impact of new regulations/guidances, as well as audit results/trends on the business

and regulatory risks and provides ongoing guidance to CQA and CRD management

6. Leads/Coordinates global HA inspectional activities, coaches staff on specialized

investigations/projects and provides assessment of reports and results from Health Authority

Inspections, including the associated risks and recommendations to relevant management

7. Evaluates aggregate audit observations and trends in order to develop periodic

compliance/metric reports and tracking, as requested by CQA management

8. Responsible for training/orientation/mentoring of newly hired CQA auditors and participates in

GCP training program of Affiliates and/or other Celgene groups

9. Reviews, develops and approves new processes, written audit procedures and tools, and

schedules training for the CQA organization, as needed

10. As requested, may perform additional responsibilities outlined in the Director’s 11. Demonstrates and promotes Celgene values and behaviors during all CQA activities

12. Travel approximately 40‐50%, domestic and international


Skills/Knowledge Required:

������ B.S. or B.S./M.S. in Chemistry, Biology, or heath related fields

������ 5 plus years direct QA/HA experience, including 10 years clinical/Industry/HA experience

������ Extensive knowledge of applicable global GCP guidelines/regulations and training

������ Requires excellent negotiation, decision‐making, leadership and interpersonal skills

������ Extensive acumen in problem solving, managing priorities and commitment to quality and

customer focus

������ Strong verbal and written communication skills

������ Strong organization, problem solving and critical thinking

������ Strong training, coaching and presentation skills

������ Ability to successfully operate in various team capacities, including leader, coaching and/or active member

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Senior-Auditor%2C-Clinical-QA-&-Compliance-Job-NJ-07901/1797214/179721417972142012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSSummit, NJ, USJob Title: Principal Scientist, Clinical Research
Job ID: 13004
Location: Summit, NJ
Offsite Territory: Category:

Clinical
Department: Hematology/Oncology - 3606


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Bachelor’s degree required – PhD, PharmD, MPH, MS or equivalent degree in life sciences or medically related field preferred

10+ years in life sciences or medically related field

Responsibilities will include, but are not limited to, the following:

- Participates in and/or facilitate study team meetings
- Prepares the protocol synopsis and final protocol (writing, reviewing, amending and cross-functional facilitation as appropriate)
- In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals.
- Acts as primary interface between the Clinician and Study Manager
- Provides input/guidance to Study Managers on scientific issues related to the operational aspects of the study
- Acts independently to uncover and resolve issues associated with the program. Escalates as appropriate
- Partners with Study Managers to ensure consistency across individual studies and programs with respect to key execution processes
- Successfully manages team conflict(s) to resolution and improved team collaboration
- Reviews data and analyses on ongoing basis, in conjunction with the Clinician, including: safety data, primary efficacy variables, and lab data
- Identifies and assists in the resolution of issues related to study design and execution
- Leads development of Clinical Dev best practices
- Function as CRP (with exception of medical decisions) in Clinical Projects
- Prepare and present draft synopsis to Synopsis Review Committee (SRC) for approval
- Review draft CRFs and provide input into CRF design process
- Involvement in the selection of KOLs and partners with them
- Present or assist with presentation of clinical data to data monitoring committees, investigators, etc.
- Prepare key documents such as Clinical Study Report, NDA/MAA submission, etc. in coordination with concerned functions (e.g. Medical writing, Regulatory, Biostatistics, etc.)
- Prepare and submit responses to Regulators during NDA review

Key experience / knowledge

- Bachelor’s degree required. PhD, PharmD., MPH, MS or equivalent degree in life sciences or medically related field preferred
- 10+ years experience in life sciences or medically related field
- Knowledge of Solid Tumor Clinical Treatment and Clinical Oncology Drug Development
- Knowledge of clinical trial design, and working knowledge of basic statistics, pharmacodynamics and pharmacokinetics
- Knowledge of Good Clinical Practice (GCP), and applicable international regulatory requirements and guidelines
- Preview experience across all study phases including design, execution and analysis
- Experience in Clinical project planning including oversight of study deliverables, budgets, and timelines
- Experience writing and presenting clearly on scientific and clinical issues, preferably Clinical protocols and Clinical Study Reports and regulatory submissions
- Expert in collaborating and leading cross-functional teams (team/matrix environment)
- Expert in operational aspects of clinical trials, e.g. as a CRA or a Study Manager
- Expert in working on clinical studies conducted internationally preferred
- Experience in oversight of outside vendors, e.g. CROs
- Viewed as an expert and leader in the field

Competencies / skills

- Ability to use scientific and clinical knowledge to conceptualize study designs
- Ability to anticipate and resolve problems
- Ability to lead cross functional efforts and teams
- Proficiency in data interpretation
- Clinical project management skills
- Excellent skills in oral and written communication
- Strong presentation skills
- Excellent interpersonal, organizational, supervisory skills
- Strong computer skills (e.g. Word, Excel, Access, Project Management software, etc.)
- Advanced analytical skills, expert influencing skills

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Principal-Scientist%2C-Clinical-Research-Job-NJ-07901/1797215/179721517972152012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSSummit, NJ, USJob Title: Associate Director, Pricing and Market Access
Job ID: 13011
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Marketing
Department: Product Marketing - 2231


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

10 years experience in health care, with significant experience in Pricing, Reimbursement, Health Economics or Outcomes Research (7 years); Post-graduate training in health economics, outcomes research, strategic marketing or related fields; Experience with complex pharmaceutical treatments, in particularly oncology or immunology, and hand-on experience support product launches (ideally both US and ex-US markets)

The Assoc Dir. Global Pricing & Market Access, will support Celgene’s marketed products as well as future disease indications. He/she will be a key strategic marketing representative providing support to the appropriate indication teams as needed to ensure optimal clinical development strategies, adequate representation of outcomes research parameters, provide price forecasts & expectations, & proactively find ways to optimize lifecycle plans. The primary focus of the role will be Celgene’s mid and early stage pipeline opportunities, and he/she will be expected to provide advanced input on demand expectations, payer strategy, health outcomes differentiators, & general market access viability. At the same time, the individual is expected to support regional/local teams in their execution of launch & access strategies for in-line marketed products.

Responsibilities will include, but are not limited to, the following:

- Identification of payer needs (unmet medical need, suitable comparators and competitive space) and anticipation of their reaction to Celgene products.
- Conduct of a gap analysis between payer expectations and what the product can deliver.
- Development of a plan to address identified gaps through studies, publications, messaging and influencing.
- Protocol design for health economic studies and integration of payer relevant endpoints in the clinical development plan.
- Development of the product’s value proposition and steering the development/updating of the product value repositories (Health Economic model, value story, commercial toolkit).
- Identification of relevant and commercially attractive assets in the product pipeline in terms of a value proposition as well as the medical need compared to existing or upcoming therapeutic alternatives in the respective indications.
- Commissioning and preparation of health economic & outcomes research analyses necessary for reimbursement submissions & competitive messaging.
- Market research and provision of regular updates on the competitor landscape for Celgene’s individual product indications.
- Significant participation with advanced strategic contribution, in Celgene’s Global indication teams
- Participation as a key member of Celgene’s Global Marketing organization.

Skills/Knowledge/Experience Required:

- Has an in-depth understanding of payers and their perspective in the key worldwide markets, as well as trends in Pricing & Reimbursement.
- Has a solid scientific background enabling the assessment of trial design impact on payer strategies and the ability to challenge clinical development or medical affairs departments.
- Has an ability to interpret and critique clinical study protocols, as well as identifying relevant clinical endpoints and conducting outcomes research in the early phases of clinical trial development.
- Has a solid commercial background, gained through graduate training or prior experience
- Has an established and extensive network of payer contacts (pricing, reimbursement, policy, insurance) and KOLs.
- Has competitive intelligence, identifies early opportunities and threats in the market and creates solutions to benefit from opportunities and to disarm threats.
- Has ability to identify key product advantages in the context of market requirements and provides key ideas for developing individual value stories around Celgene’s products.
- Can develop a clear understanding of the company’s financial goals, with a clear ability to prioritize, setting up timelines on an international level.
- Can effectively liaise with Celgene Medical Affairs and Marketing teams, Celgene’s indication teams as well as Celgene’s local and regional teams, creating an efficient working style within a diverse organizational matrix.
- Possesses a commercial drive that leans toward strategic marketing, while at the same time is comfortable with technical or academic topics.
- Preferably has multi-year experience with health authorities, governmental economists and reimbursement agencies, hospital administrators and health care insurance companies’ general management, acquired at pharmaceutical companies, sickness funds, physician associations or health care consultancy companies.

Competencies Required:

- Ideally has 10+ years experience in the health care field, including significant experience in pricing, reimbursement, outcomes research or health economics, in the pharmaceutical areas of Oncology, Immunology or other innovative and complex treatments.
- Has graduate level (Master or higher) training in economics or an analytical commercial discipline.
- Displays excellent business English skills, with first-rate communication abilities.
- As a representative of a function, good social / economic skills and a representative appearance is absolutely essential.
- Has strong influencing/negotiation skills and the ability to work at peer-level with experienced technical and commercial experts in other departments
- Displays business confidence to constructively challenge marketing and clinical colleagues
- Has excellent written, verbal and interpersonal communication skills, with the ability to communicate complex or technical content in a convincing way to non-technical audiences.
- Is a flexible team member with a positive attitude and the ability to prioritize projects.
- Is experienced and adept at navigating international, multi-lingual, and cross-functional organizational matrices within a diverse and cross-cultural work environment

Performance measurement:

- Timeliness, accuracy, completeness and quality of work team milestones, accomplishment of financial company targets and execution of Global objectives.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Associate-Director%2C-Pricing-and-Market-Access-Job-NJ-07901/1798825/179882517988252012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSSummit, NJ, USJob Title: Manager, Medical Affairs Operations
Job ID: 13012
Location: Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Medical Affairs
Department: Medical Affairs Operations - 3618


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

1. BS/BA in a health-related science or RN.
2. Eight to ten years of experience in clinical research, clinical coordinator, clinical nurse role or an equivalent combination of education and experience.
3. In-depth knowledge of drug development process, FDA, ICH, and GCP guidelines.
4. Experience implementing, monitoring, and/or managing clinical trials for academic clinical research or pharmaceutical/biotechnology company
5. Oncology experience is strongly preferred.

Through direction of the Sr Manager, Medical Operations, the Manager, Medical Operations is responsible for working within the Medical Affairs Operations function to develop, coordinate, maintain, report and ensure the successful completion of deliverable within the US Medical Affairs. The Manager, Medical Operations will lead, direct, manage and coordinate the operational efforts of the Medical Operations team in the development and implementation of research-driven, investigator-initiated clinical trials in collaboration with the Regional Medical Liaisons.

Responsibilities will include, but are not limited to, the following:

1. Effectively leads team of Clinical Trial Specialists by providing consistent positive and constructive feedback to enhance performance of direct reports. Recognizes and motivates team to achieve results.
2. Reviews and manages all aspects of Investigator Sponsored Study program and trials from LOI receipt to publication.
3. Provides operational support to the Regional Medical Liaisons (RML) thereby establishing a direct line of communication between the RML and the Clinical Trials Specialists.
4. Adjusts priorities and demonstrates adaptability, identifies and implements new or different ways to achieve goals.
5. Uses knowledge of the drug development process in the planning and management of clinical studies.
6. Develops operational reports to facilitate decision making, identifying team accomplishments, areas of focus, process improvements, priorities and issue resolution.
7. Communicates frequently with Sr Manager, Medical Operations to ensure team is provided information needed to keep projects on track.
8. Tracks project progress and resource utilization.
9. Listens actively and shares relevant information with others.
10. Develops effective working relationships with business partners to achieve business goals.
11. Identifies, analyzes, and communicates problems, issues, and opportunities. Develops and implements effective solutions to achieve desired outcomes.
12. Demonstrates an understanding of study drug and industry competition.
13. Understands the disease state and treatment options.
14. Develops project plans and manages multiple projects to achieve goals within established timelines.
15. Evaluates and manages time and resources among direct reports.
16. Collaborates to identify strengths and developmental areas; creates, owns, and implements professional development plan.
17. Assist with any special projects as assigned.


Skills/Knowledge Required:

- Ability to communicate effectively in the English language in person, by phone and in writing.
- Proven management and organizational skills.
- Excellent presentation and PowerPoint skills
- Excellent organizational skills.
- Ability to work collaboratively, effectively, and productively in diverse organization structures.
- Ability to work in a team-oriented, collaborative environment.
- Ability to motivate and direct team members.
- Ability to demonstrate strong leadership capabilities and negotiation skills.
- Solid computer skills and practical knowledge of MS Word, Excel, PowerPoint and project management software.
- Ability to be flexible and manage change easily.
- Ability to work positively within a continually changing environment.
- Ability to problem-solve
- Ability to effectively prioritize and execute tasks in a high-pressure environment.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Manager%2C-Medical-Affairs-Operations-Job/1804398/180439818043982012-06-14Celgene CorporationMedical Affairsfull-timeUSDstarting0BSJob Title: Security Specialist (Analyst II, IT)
Job ID: 13019
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: ITGOS Security - 4164


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Bachelor's degree in a technical discipline or equivalent plus a minimum of 7 years of network, computer, or other technical experience, including 3 years of information security experience required.

Reporting to Celgenes Information Security Director the security analyst position is part of an overall team responsible for enterprise-wide oversight and coordination of information technology security efforts to reduce risks, respond to incidents and limit exposure to liability and risk with regard to IT systems, networks and applications. This position utilizes strong policy and process knowledge as well as skills and expertise with a variety of technologies. It also involves interaction with numerous other departments and business functions.

Responsibilities will include, but are not limited to, the following:

- Accountable as part of a team for implementation of the Information Security program for Celgene Corporation.
- Stay current on changes in the Pharmaceutical industry, Celgenes products and services, and information security terms, concepts, practices, and policies, as well as changes in the regulatory and audit requirements with respect to information security and privacy on a Global basis.
- Ability to identify significant information security risks, execute design and implementation of strategies and programs to prevent or reduce the loss of organizational assets.
- Address and/or escalate information security issues and concerns to the Information Security Director – Celgene.
- Remain current in state-of-the-art technology solutions and innovative information security management techniques to safeguard organizational assets.
- Communicate effectively with clients to address complex information security issues with limited assistance.
- Support information security awareness throughout the organization to educate on information and security risks and solutions.
- Prepare and review activity reports as requested by management.
- Develop close working relationships with management, company peers, and industry counterparts to ensure alignment of company goals with current information security industry and regulatory trends.
- Keep Information Security management apprised on the status of information security issues and initiatives.
- Perform other related duties as assigned.

Education/Experience/Skills

- Bachelor's degree in a technical discipline or equivalent plus a minimum of 7 years of network, computer, or other technical experience, including 3 or more years of information security experience required.
- Well versed in information security concepts (e.g. defense in depth, separation of duties, control environments, malicious software, security awareness etc.).
- Working knowledge of IT technologies (for example, operating systems, network protocols, information security management systems etc.)
- Working knowledge of information security technologies (e.g. firewalls, proxy servers, IP/load balancers, wireless networks, VPN and cloud)
- Working experience with security monitoring solutions (e.g. IPS, NAC, DLP, SIEM etc.)
- Strong working experience in intrusion monitoring, incident response and forensics
- Experience in role based application and infrastructure security (e.g. Active Directory / Identity Management / LDAP etc.)
- Strong demonstrated knowledge of industry best practices in regard to network security (e.g. NIST, SANS, NSA etc.)
- Working knowledge of various regulatory and broad security best practice standards and guidelines (e.g. ISO 27002, PCI, SOX, EU Privacy, HIPAA, Safe Harbor etc.)
- Demonstrated experience with technology and methodologies standard to network engineering
- Proficient at multitasking and prioritizing in a fast-paced environment.
- Ability to communicate verbally and in written forms in a professional manner.
- Ability to plan and organize work schedule for self.
- Ability to work as both a team member and leader, meet team schedules, and contribute to the team's goals and objectives.
- Provide assistance to technical and management personnel as required.
- Actively participate in meetings and provide constructive input.
- Facilitate when requested, meetings, establish agendas, and document follow-up actions as needed.
- Experience working in a global (multinational) environment is required
- Experience in the Pharmaceutical industry is a plus

Professional Certifications

Certified Information Systems Security Professional (CISSP), Global Information Assurance Certification (GIAC), or applicable technical certifications a plus.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120413
]]>http://jobs.celgene.com/job/Berkeley-Heights-Analyst-II%2C-IT-%28Security%29-Job-NJ-07922/1806896/180689618068962012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBerkeley Heights, NJ, US
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Apply Without Selecting Job]]>http://jobs.celgene.com/job/Phoenix-Analyst%2C-QC-Chemistry-3rd-Shift-Job-AZ-85001/1808957/180895718089572012-06-14Celgene Corporationfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Document Control Specialist
Job ID: 13026
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Quality Improvement - 1115


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a High School Diploma or equivalent with a minimum of 6 years related Quality Assurance and/or Quality Control experience in a regulated setting, preferably in a pharmaceutical environment.
- Prefer an Associate’s degree in a related science from an accredited college or university with a minimum of 4 years related experience in a regulated setting, preferably in a pharmaceutical environment.
- An equivalent combination of education, experience and training may substitute.

POSITION SUMMARY

Administers elements of the entire site Document Change Control process, both DCCs (for SOPs and Forms), and DCRs (for product-related documentation). Uses manual and electronic document management tools and systems to perform document change control duties. Creates, maintains, and/or verifies ERP system material and product master data. Issues implemented batch documentation to production. Under general supervision, develops Standard Operating Procedures (SOPs) and forms for areas of expertise within the QA Document Control group. Works and interacts with Manufacturing, QA, QC, PPIC and other personnel on a routine basis.

ESSENTIAL FUNCTIONS

- Processes and implements DCRs and DCCs: Prepares document drafts and final masters per approved document change controls; Reviews document change packages submitted to assure all required documents are complete and present; initiates approval routings, schedules and implements approved changes; notifies appropriate personnel of new, revised and obsolete documentation; Manages/coordinates controlled document periodic review process.
- Creates, maintains and/or verifies learning management system records associated with implemented controlled documentation.
- Creates, maintains and/or verifies ERP system material master, bill of material, recipe and resource structures; assures incorporation of master data changes per document change control instructions.
- Maintains electronic master document files in orderly manner.
- Maintains current master hard-copy and history documentation files as defined in departmental SOPs.
- Maintains databases for QA Document Control group in order to monitor document approval and change status.
- Coordinates and maintains controlled documentation received from other departments or from outside the site; administers and monitors site approval process as needed.
- Participates in scheduling and planning meetings with PPIC and production, and other project teams, as assigned.
- Issues batch documentation to production as per PPIC instructions and production schedule.
- Revises or creates SOPs, forms and document change controls relating to departmental subject matter.
- Participates in or conducts investigations and corrective actions affecting the department as may be assigned.
- Participates in or conducts training on topics related to department activities, as may be assigned.
- Performs related duties and special projects as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Document-Control-Specialist-Job-AZ-85001/1808958/180895818089582012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Associate Director, Commercial Supply Chain
Job ID: 13022
Location: Basking Ridge, NJ -110
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Manufacturing - 1101


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Bachelor’s degree required. Advanced degree preferred.

Minimum 10 years in multiple organizational contexts within Supply Chain operations in biopharmaceutical industry desired.

Summary:

The Associate Director of Commercial Supply Chain plays a key role within Technical Operations at Celgene bearing responsibility for providing senior management with operational support in order to effectively and efficiently manage our commercial supply chain operations. The Associate Director must excel at working in a collaborative, diverse, complex, resource-constrained environment and be able to support decision-making processes that involve multiple constituencies and constraints.


Responsibilities will include, but are not limited to the following:

- Assist function head in developing the strategic, operational and financial objectives for major commercial supply chain operations projects in alignment with business strategies. This includes developing business case analyses, budgets and business requirements for project initiation; evaluation of alternative solutions and selection of recommended solutions in partnership with the business stakeholders as basis for senior management decision.
- Evaluate opportunities within commercial supply chain operations to maximize operating efficiencies and reduce costs via business process re-engineering initiatives, make versus buy analyses, process out-sourcing, etc. Prepare corresponding operational and financial analyses (NPV, ROI) to support management decision-making process.
- Create, optimize, and administer the manufacturing capacity plan for global commercial supply chain network. Continuously assess network capacity and work with senior manufacturing management to develop mitigation plans for constrained or underutilized assets & resources.
- Work with subject matter experts in Regulatory CMC, Manufacturing, Logistics as well as Finance/Treasury to document global product flows of all commercial products.
- Provide senior management with timely, reliable and well structured information regarding commercial supply chain performance including KPI’s, variance analysis and contingency plans for corrective measures.
- Business function lead in systems related projects impacting commercial supply chain including the development of project budgets and schedules, business user requirements, resource planning estimates, CAR’s, etc.
- Represent commercial supply chain as business function project manager for new systems or enhancements to existing systems impacting commercial supply chain. Responsibilities include coordination of project team members, consultants and subject matter experts in design, execution, testing, and training as well as post go-live business support activities. Track and monitor team progress and take steps to remediate issues that adversely impact project budgets, schedules and deliverables.
- Support the development of harmonized policies, SOP’s, work practices, etc. within global commercial supply chain.
- Identify key supply chain trends and technologies that might be leveraged to improve commercial supply chain operations.
- Be a source of supply chain function knowledge within Technical Operations.

Scope:

- - Span of Control – Commercial Supply Chain operations within global Technical Operations
- - Direct Reports – 1 or more direct reports in future (Supply Chain Analysts)
- - Indirect Reports – 10 to 12 project/program resources
- - Budgetary Responsibility –
- - Interacts with – Sr. Director Supply Chain Operations, as well as senior business management across Technical Operations and Quality Operations.


Skills/Knowledge Required:

- Bachelor’s degree in supply chain, engineering, mathematics, chemistry, biology or related field. Advanced degree (MS/MBA) preferred.
- Greater than 10 years experience in multiple organizational contexts within supply chain operations in biopharmaceutical industry. Experience should range from supply chain planning & procurement, manufacturing, logistics, etc.
- Knowledge of regulatory requirements in the areas of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)
- Broad and diverse business experience ranging from strategic planning & analysis, Sales & Operations Planning (S&OP), new product launches, strategic supply chain sourcing as well as operations integration associated with M&A’s.
- Strong experience in the operational use of enterprise resource planning (ERP) applications such as Oracle or SAP specifically in supply chain planning & procurement, manufacturing and logistics within the biopharmaceutical industry.
- Understanding of financial concepts such as NPV, ROI, TCO, etc.
- Solid skills in staff mentoring, performance evaluation and life-long learning
- Effective communication and leadership skills in building high performance teams.
- Ability to work independently with internal and external groups on multiple simultaneous projects.
- Flexible, adaptable and hands-on approach necessary.

Willing to travel 10 – 20% domestically and internationally occasionally on short notice

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120406
]]>http://jobs.celgene.com/job/Basking-Ridge-Associate-Director%2C-Commercial-Supply-Chain-Job-NJ-07920/1808960/180896018089602012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSBasking Ridge, NJ, USClinical R&D
Neuchatel, Switzerland

PREREQUISITES

Relevant advanced scientific [or nursing] degree (e.g. MS, BS or RN)

Minimum 5 - 7 years experience in clinical research development or equivalent with specialization in Hematology or Oncology

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

A Main:

- Guides the successful activities for assigned clinical studies
- Responsible for completion of milestones associated with specific clinical studies
- Guides multiple complex studies and directs the planning and implementation of clinical programs to meet corporate and clinical research goals
- Key contributor of relevant clinical study information in team meetings and interface with the study team (including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management)
- Primary scientific contact on studies before study physician or Medical Project Director
- Participates in the Development Planning for assigned compounds in specific disease areas
- Assist Medical Director/ Medical Project Director to make recommendations, take action and provide clinical research expertise related to projects

B Study related activities:

- Prepare key documents: Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate), regulatory submission documents, Clinical study report preparation, internal or external presentations, etc.
- Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
- Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety)
- Collaborate and support operational activities as need be
- Participate in establishing project budgets
- Participate in reviewing ongoing summary data including: safety, primary efficacy variables, and laboratory data

Skills/Knowledge Required:

A Need:

- For an associate level a minimum 2 yrs. experience in clinical research, either in academic institution, or cooperative group, CRO or pharmaceutical industry, covering experience in above mentioned responsibilities, listed under B
- For a clinical research position 4 to 7 years in a scientific function in clinical research are required, experience in Clinical Research in Hematology/Oncology is strongly recommended
- Ability in analyzing data, experience in clinical study design, protocol writing and informed consent conception
- Profound medical/scientific and clinical research knowledge
- Excellent written and verbal communication skills and interpersonal skills
- Must be able to relate effectively to people at all levels of the organization
- Able to apply scientific knowledge and understands the role of complementary functions within the team
- Competent to work in cross functional, multinational teams
- Proactively takes initiatives and keeps all stakeholders and manager informed to assure alignment
- Knowledge of GCP and ICH Guidelines

B Skills:

- Detail-oriented, well-organized
- Ability to assimilate technical and scientific information quickly
- Proficient in Microsoft Word, Excel, PowerPoint
- Demonstrated ability to work as part of a team
- High level of interpersonal and communication skills (written and verbal)
- Excellent written and oral English skills]]>http://jobs.celgene.com/job/Neuchatel-Clinical-Research-Scientist-Job/1808961/180896118089612012-06-14Celgene CorporationClinical R&Dfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Director, Global Marketing Multiple Myeloma
Job ID: 13029
Location: Summit, NJ
Offsite Territory: Category:

Marketing
Department: Product Marketing - 2231


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BA/BS required; MBA preferred

The Director of Global Marketing is a key member of the Multiple Myeloma(MM) disease team responsible for providing strategic leadership to successfully drive franchise development across both current and future indications.

Responsibilities will include, but are not limited to, the following:

1. Leading the strategic marketing for an assigned brand / indication, including the development of global launch plans, long-term disease plans, financial forecasts and analysis.
2. Provide strategic leadership to the Multiple Myeloma global disease team
3. Provide marketing direction at all stages of development and decision-making; including proposed markets, positioning, forecasting, pricing strategies, Phase II/III/IV projects, life-cycle management and scientific / promotional communications.
4. Managing annual promotional budgets and determining the best allocation of global resources for the brand/indication.
5. Works with HQ legal, regulatory, medical affairs, market research, clinical development, & translational medicine to ensure global alignment of the proposed strategy.
6. Works with regional (ie. Americas, EMEA, SEA, JPN) marketing & sales management, legal, regulatory, medical and market research to ensure appropriate understanding and implementation of the global product strategies.
7. Monitoring the competitive environment and customer base to quickly identify opportunities and threats within the market.
8. Lead the development/management of relationships with key professional and patient advocacy organizations.
9. Develop and deliver presentations to senior management and other internal/external stakeholders.
10. Work with business development to provide commercial input and conduct due diligence


Skills/Knowledge Required:

- Must demonstrate ability to lead strategically, drive performance, build alignment, inform, negotiate and collaborate.
- Strong science background with deep knowledge of the oncology/hematology area
- Effective communication at all times. Experience in delivering complex messages to various internal and external customers with a track record of effective and influential presentations.
- Demonstrated initiative, creativity, strategic capabilities, and ability to work effectively in complex, rapidly changing environments
- Strong project and process management skills, along with the ability to work on multiple tasks, and to effectively prioritize.
- Must be able to conceptualize and articulate a vision for self and brand that energizes all functional areas and stakeholders.
- Proven team player with ability to navigate cross functionally.
- Ability to interact with, influence and provide direction to multiple functions as part of the global disease team

Successful candidate should have at least 10 years industry experience with 5+ years of oncology/hematology marketing experience.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Director%2C-Global-Marketing-Multiple-Myeloma-Job-NJ-07901/1812220/181222018122202012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSSummit, NJ, USJob Title: Commercial Director - Brazil
Job ID: 13021
Location: OffSite
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Marketing
Department: Product Marketing - 2231


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

- BA/BS required; MBA/graduate degree strongly preferred
- 10 to 15 years of experience in the Pharmaceutical Industry (Multinational)
- Fluent in English (oral and written) is required
- Business Unit Franchise experience is required, Hematology/Oncology is preferred; Specialty Products required
- Partnership management experience is preferred

General Description:

The Commercial Director will have full responsibility for this newly created position, reporting to the Regional General Manager, Latin America and the position will be located in Sao Paolo, Brazil. The individual will oversee the development and implementation of the strategic business plan. The Commercial Director will manage a small but dedicated team of experts, and act as the point of contact with our local distribution partners, customers and government agencies.

Major Responsibilities:

- Ensure effective financial planning. Continually review financial performance to identify both positive and negative variances; develop action plans to address opportunities and challenges. Manage expenses to budget and deliver targeted sales and profit contribution
- Hire and manage a team of experts. Establish appropriate performance metrics. Coach, develop and retain the team. Set clear expectations, give appropriate autonomy and measure performance
- Serve as point person responsible for managing and optimizing local partnerships
- Maximize the commercial potential of our assets through the development and implementation of strategic marketing plans in collaboration with Regional Marketing and our partners
- Establish market sales and resource forecasts, initiate relevant market research projects to support the strategic brand planning process
- Lead market opportunity assessments and make recommendations on products with the most significant commercial or strategic importance for Celgene
- Oversee and lead the execution of new product and lifecycle launches
- Partner with Regional Marketing on key projects, meetings and congresses
- Establish strong relationships with customers, payers, NGOs, and government agencies
- Provide commercial input for business development opportunities
- Ensure that all business activities are in line with company policies and procedures

Ideal Experience:

- A seasoned and well-rounded pharmaceutical executive with 10 to 15 years of experience in a variety of marketing and sales roles of progressively greater scope and responsibility. The executive must have extensive commercial experience with specialty products (Hematology/Oncology preferred). The individual should have 3+ years of managing a Business Unit Franchise (Hematology/Oncology preferred)
- Successful management experience with direct responsibility for a team and a demonstrated track record of delivering top line growth and bottom line performance
- Led cross functional teams and managed partnerships
- Proven command of classic marketing disciplines and techniques. Demonstrated success in commercial planning, launching products and product life cycle management

Leadership Competencies Required:

- Demonstrates ability to lead strategically and cross functionally to drive performance
- Experience in delivering complex messages to various internal and external customers with a track record of effective presentations
- Demonstrates initiative, creativity, strategic capabilities and ability to work effectively in complex, rapidly changing environments
- Proven team player with the ability to navigate cross functionally
- Develops strategies that support Celgene’s vision, values and long-range business plans
- Communicates the company’s vision and strategies in a way that builds the understanding and commitment of others, both internally and externally
- Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics or strategies
- Pursues new initiatives and opportunities based on their fit with Celgene’s broader strategies
- Builds a culture of energy and commitment that challenges people to excel
- Attracts and selects highly talented people, based on a clear understanding of the competencies required
- Anticipates future organizational needs when selecting and developing talent
- Supports direct reports in developing effective working relationships throughout the organization
- Motivates and inspires direct reports to achieve goals; holds direct reports accountable for achieving goals
]]>http://jobs.celgene.com/job/Commercial-Director-Brazil-Job/1812221/181222118122212012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSJob Title: Director, Drug Safety Physician
Job ID: 13030
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Drug Safety
Department: Drug Safety - 4202


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Minimum of MD (or international equivalent)
- Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred
- Eight (8) years relevant clinical experience, including training
- Four (4) years pharmaceutical/biotechnology industry experience
- Thorough appreciation of global regulatory requirements for pharmacovigilance
- Clinical knowledge of therapeutic area patient populations and drug class


Summary

- To support a single interpretation of global safety data for defined products
- To assist in identifying and managing safety concerns with approved Celgene products
- To contribute to aggregate analyses and reports addressing approved product safety profiles.

Governance

Company Safety Committee (CSC)

- Support meeting preparations
- Develop review topics/CSC agenda items
- Support closure on recommendations

Internal DMCs

- Support internal DMC meeting preparation
- Provide input to DMC Charters

External DMCs

- Support meetings through safety data provision
- Participate in meetings as required

Product Labelling

Labelling Working Group participation

- Participate in working group meetings as required

Core Data Sheet Creation

- Contribute to data sheet development

Core Data Sheet Maintenance

- Develop proposed edits to existing core data sheets

Package Insert / Labeling Updates

- Contribute to labelling update impact summaries for use by CSC
- Support labeling prose text updates, based on internal aggregated reports

Issues management

Issues Management

- Support the development of strategies for issue management
- Facilitate internal approval of plan
- Support review of issue data and closure on recommendations

Crisis Management

- Contribute to the formulation & specification of a rapid response system & corporate policy / procedure to address safety crises

Regulatory Enquiries

- Contribute to the review of relevant data required for response
- Support the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysis
- Contribute to response drafting
- Review draft responses as required

Safety Enquiries (Internal, External, HCP & consumer)

- Contribute to the evaluation of safety enquiries
- Review response data

AE Case Management

Triage

- Review and provide immediate input to escalated reports as needed

Medical Review

- Support medical review as required (narrative, coding, labeling, causality, company comment)
- Provide input to case management standards as required

Commercialization support and liaison to other functions

Commercial Support

- Provide training to Celgene employees on product safety profiles/issues
- Review publications, including abstracts, manuscripts, and speaker presentations

Internal Liaison

- Provide product based liaison for Celgene functions (Legal, Buis Dev, Operations, Marketing, etc.)
- Execute appropriate communication of safety data & interpretation to Celgene and external parties, globally

European/International Safety Communication & Co-ordination

- Support training to Celgene employees on product safety issues & profiles

Compliance, Standards, Training & Project Management

Preparation for Regulatory Inspection

- Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates

Extra-Departmental Liaison & Co-ordination

Clinical Operations Support

- Contribute to the preparations for weekly clinical operations team meetings

Commercial / marketing support

- Contribution to development of differentiation of Celgene products
- Provide training guidance to marketing training materials
- Review and contribute to marketing materials

Quarterly Product Memo

- Support the creation of a quarterly product memo for defined products

Internal Global Safety Department Development

Interfaces

- Support GDS product co-ordination

Pharmacovigilance(approved products, incl further studies)

Safety PV processes

- Support safety PV process definition for Celgene and competitor products
- Contribute to weekly SAE report review

Signal Detection and Analysis

- Support proactive, ongoing analysis of SAE’s by system, compound, and TA to detect significant correlation/causation

Internal Review

- Review materials as part of the quarterly review meeting

Pharmacovigilance(approved products, incl further studies) (contd)

Maintain Product Safety Profile

- Support the development & maintenance of product safety profiles and definition of events of Interest

Quarterly Product Safety Reviews

- Support data presentations at quarterly and ad hoc product safety reviews
- Support closure on recommendations

Product PV Plan / Program

- Support the development and updating of Product PV program/plans
- PSURs/PSRs
- Provide PSUR/PSR support
- Review PSURs/PSRs

Response to Regulatory feedback to PSUR and PSR

- Review PSUR/PSR responses

Risk Management Plan Development

- Contribute to the definition of RMP drivers & content
- Review RMPs

Execution of Risk Management Plan

- Contribute to the execution of RMP elements
- Support the evaluate potential risks for evidence of risk confirmation

Post Approval Commitments

- Contribute to the development of safety PAC proposals

Events of Interest management

- Support the definition of events of interest
- Contribute to the definition of case follow-up needs

Product Launch Plan

- Contribute to product launch plans

Publications

- Contribute to draft papers

Pharmacoepidemiology

Global PE strategy

- Contribute to the development of a Global PE strategy

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Director%2C-Drug-Safety-Physician-Job-NJ-07922/1812222/181222218122222012-06-14Celgene CorporationDrug Safetyfull-timeUSDstarting0BSBerkeley Heights, NJ, USClinical Operations
Neuchatel, Switzerland

PREREQUISITES

Minimum 1 - 2 years of relevant industry experience, preferably related to Contracts/Finance

Valid Swiss working permission or EU Citizenship required

Position summary:

- Under the direction of Outsourcing and Contract Management personnel, this individual will be responsible for coordinating contract documentation workflow. He/she will also assist in generating agreements including but not limited to Confidentiality Agreements, Consulting Agreements and Clinical Study Agreements. The Contracts Administrator will have frequent contact with all departments of the corporation as well as investigators and vendors and will keep track of requests and completed agreements. High volume of contracts requires the ability to meet deadlines and to manage priorities. Must be willing to work in an environment where individual initiative and accountability to the team are required.

Responsibilities include, but are not limited to:

Generate, edit and version control of specified documents (including but not limited to Confidentiality Agreements, Consulting Agreements & Clinical Study Agreements) capturing all changes to original templates using compare and merge and track change tools

Proactive Coordination and Facilitation of the Contract execution process, by ensuring:

- Each contract has appropriately detailed approval documentation according to Celgene procedures, including SOP’s & signature policies
- Internal and External communication is delivered diligently and in a professional manner
- Ensure contracts are tracked and archived with all contracts information within required timeframes

Maintenance of contracts & archive files and related databases proactively, accurately to ensure real time information

Assist in various other matters or initiatives as relevant to contract coordination and generation.

Screening and handling contracts requests received at internationaloutsourcing@celgene.com as appropriate

Contribute to continuous improvement

Skills/Knowledge Required:

- Preferred experience in some aspect of pharmaceutical clinical trials
- Understanding of basic concepts with respect to Confidentiality, Consulting and Service/Vendor Agreements (preferably, with a pharmaceutical company)
- Strong PC experience and Microsoft Office experience required.
- Excellent written and verbal communication skills and interpersonal skills. Must be able to work in a multicultural team environment and interact with a wide variety of customers
- Must be a team player and be willing to work in an environment where individual initiative and accountability to the team are required
- Proven ability to multi-task
- Sense of urgency
- Must possess good organizational skills with the ability to prioritize as well as great attention to detail
- Excellent English language skills absolutely required, additional languages are advantageous
- Minimum of 1-2 years of work experience required]]>http://jobs.celgene.com/job/Neuchatel-Contracts-Coordinator-Job/1816433/181643318164332012-06-14Celgene CorporationClinical Operationsfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Senior Manager, Corporate Financial Planning & Analysis
Job ID: 13035
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Finance
Department: Corporate Accounting - 4121


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

Education: BA or BS in Finance/ Accounting. MBA and/or CPA strongly preferred (or equivalent work experience).

Experience: 7+ years of Finance/ Accounting with a minimum of 3 years of industry experience.

Purpose of the function

The primary focus of the function is the direction and management of the financial planning for Celgene worldwide and the reporting of actual and forecasted financial performance to Finance Business Partner(s) to allow pro-active and timely decision making.

Specifically this position shall assist in developing , implementing and monitoring the Budget and Planning process for the assigned Finance Business Partner(s) as well as provide support to the Corporate FP&A function

Responsibilities will include, but are not limited to, the following:

- Assist with the preparation of financial and highlight reports for Senior Management. Reports include summarized financial statements, qualitative business insights and financial and operating metrics
- Assist the central function with the support for the Strategy and Business Development functions
- Provide finance consulting and advice to the responsible Function Head(s)as well as assist with the strategic planning for the assigned function
- Coordinate and collate periodic forecasts of actual versus budget performance for the assigned function(s), validate submitted forecasts and submit forecasts to the central FP&A team
- Manage and coordinate the local purchase order process in collaboration with Strategic Sourcing and Shared Services teams
- Manage, coordinate and validate headcount information in collaboration with HR
- Work closely with the Finance Shared Service Center to ensure complete and accurate accounting
- Work on ad-hoc projects assigned by Function Head


Skills/Knowledge Required:

- MBA/CPA and degree in Finance/Accounting or Business Administration
- At least 7 years experience in Finance/Accounting, thereof at least 3 years in the Pharmaceutical industry
- Excellent skills and proficiency with Microsoft Office products e.g.Excel and PowerPoint and a good knowledge of Business Intelligence software e.g. Business Objects and Hyperion
- Solid experience in a rapidly expanding multinational environment
- Ability to tailor work approach from detail oriented to strategic overview with strong process development skills.
- Ability to identify existing or potential deficiencies in operating processes or procedures, recommend solutions, and proactively seek continuous economic and operating efficiencies primarily through leveraging financial systems
- Strong communication skills and the ability to interact with all levels of management and the ability to influence processes across multiple functions and geographies

Behavioral Competencies:

- High sense of urgency and ability to identify creative solutions to advanced, time sensitive problems by balancing achievement of process objectives with practical considerations
- Flexible personality who easily adapts to the fast moving business environment

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Senior-Manager%2C-Corporate-Financial-Planning-&-Analysis-Job-NJ-07922/1816435/181643518164352012-06-14Celgene CorporationFinancefull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Senior Director, Financial Planning & Analysis for Research & Development
Job ID: 13036
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Finance
Department: Corporate Accounting - 4121


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

Education: BA or BS in Finance/ Accounting. MBA and/or CPA strongly preferred (or equivalent work experience).

Experience: 12+ years of Finance/ Accounting with a minimum 6 years of both supervisory and industry experience.

Purpose of the function

The primary focus of the function is to act as Finance Business Partner to the Research and Development Function Heads, providing financial guidance and support to manage expenses to meet annual business plans and the long-term objectives of the organization. Additionally, the position shall oversee and manage all finance and finance related processes of the supported function. This includes the monitoring, measurement, analysis and interpretation of the financial performance and the coordination of forecasts and budgets.

Responsibilities will include, but are not limited to, the following:

1. Assist in developing and implementing an integrated financial model to support the function and to monitor R&D collaboration activities
2. Provide finance consulting and advice to the responsible Function Heads
3. Oversee the accounting/relationship for collaborations and acquisition-related assets and liabilities, including the daily operations and true up payments, as well as the contingent payments
4. Assist in creating a process to aggregate multi-functional Project costs to provide key management with reporting and analysis in order to support operational and strategic decisions with respect to clinical trials
5. Supervise a team of professionals responsible for the financial support of the R&D functions
6. Coordinate and collate periodic forecasts of actual versus budget performance for the assigned function, validate submitted forecasts and submit forecasts to the central FP&A team
7. Coordinate the budget process for the assigned functions
8. Manage/coordinate the local Purchase Order process in collaboration with Strategic Sourcing and Shared Services teams
9. Manage, coordinate and validate headcount information in collaboration with HR
10. In conjunction with the Function Head, assist with the strategic planning for the assigned function
11. Work closely with the Finance Shared Service Center to ensure complete and accurate accounting
12. Work on ad-hoc projects assigned by Function Head


Skills/Knowledge Required:

- MBA/CPA and degree in Finance/Accounting or Business Administration
- At least 12 to 15 years experience in Finance/Accounting, thereof at least 6 years in the Pharmaceutical industry
- Exceptional managerial skills and ability to create vision and strategy to drive team objectives and performance.
- Solid experience in a multinational environment
- Detail oriented with strong analytical and problem solving skills. Ability to identify existing or potential deficiencies in operating processes or procedures, recommend solutions, and proactively seek continuous economic and operating efficiencies
- Strong written and verbal communication skills and the ability to interact with all levels of management and the ability to influence management across multiple functions and geographies
- Proficiency with MS Office tools, experience with Oracle EBS, Business Objects and Hyperion

Behavioral Competencies:

- High sense of urgency and ability to identify creative solutions to advanced, time sensitive problems by balancing achievement of process objectives with practical considerations
- Excellent collaboration skills
- Strong customer service focus, with a drive to ensure that we exceed the expectations of our customers

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Senior-Director%2C-Financial-Planning-&-Analysis-for-Research-&-Development-Job-NJ-07922/1816436/181643618164362012-06-14Celgene CorporationFinancefull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Director, Corporate Financial Planning & Analysis
Job ID: 13034
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Finance
Department: Corporate Accounting - 4121


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

Education: BA or BS in Finance/ Accounting. MBA and/or CPA strongly preferred (or equivalent work experience).

Experience: 12+ years of Finance/ Accounting with a minimum of 4 years of industry experience.

Purpose of the function

The primary focus of the function is the direction and management of the financial planning for Celgene worldwide and the reporting of actual and forecasted financial performance to Senior Management to allow pro-active and timely decision making. Specifically this position shall assist in developing , implementing and monitoring the Corporate Budget and Planning process for Celgene, as well as provide strategic analysis and support for growth opportunities.

Responsibilities will include, but are not limited to, the following:

- Assist the Executive Director of FP&A in developing and implementing an integrated financial budget and planning process for the organization
- Provide assistance in the development and/or consolidation of forecasts, budgets, long-term plans, and fluctuation analysis and the global coordination of financial planning
- Partner with the Strategic Planning and Business Development teams to develop , integrate and operate a financial modeling process in order to support long term growth opportunities as well as new licensing and collaborations initiatives
- Responsible for long term balance sheet and cash flow projections in connection with the financial modeling initiative
- Provide finance support on an as needed basis (including forecasting and budgeting) for the business functions that are not supported by a decentralized Finance Business partner
- Work on ad-hoc projects assigned by the Function Head


Skills/Knowledge Required:

- MBA/CPA and degree in Finance/Accounting or Business Administration
- At least 12 years experience in Finance/Accounting, thereof at least 4 years in the Pharmaceutical industry
- Proven system knowledge in developing strategic process (with a particular emphasis on Oracle EBS, Business Objects and Hyperion)
- Exceptional managerial skills and ability to create vision and strategy to drive team objectives and performance.
- Solid experience in a rapidly expanding multinational environment
- Detail oriented with strong process development skills. Ability to identify existing or potential deficiencies in operating processes or procedures, recommend solutions, and proactively seek continuous economic and operating efficiencies primarily through leveraging financial systems
- Strong communication skills and the ability to interact with all levels of management and the ability to influence processes across multiple functions and geographies

Behavioral Competencies:

- High sense of urgency and ability to identify creative solutions to advanced, time sensitive problems by balancing achievement of process objectives with practical considerations
- Excellent collaboration skills

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Director%2C-Corporate-Financial-Planning-&-Analysis-Job-NJ-07922/1816438/181643818164382012-06-14Celgene CorporationFinancefull-timeUSDstarting0BSBerkeley Heights, NJ, USMedical Operations
Neuchatel, Switzerland

PREREQUISITES

See below for specific PREREQUISITES depending on Outsourcing Specialist/Manager level

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

- Vendor selection leadership: Lead cross-functional teams. Manage and influence the vendor selection process including project priorities and timelines by preparing RFP packages including detailed specifications for contract activities, reflecting country-specific issues, reviewing and providing cost comparisons for all received proposals, organizing and chairing CRO presentations, and driving the project team decision-making process.
- Contract preparation and negotiations: Prepare the contract document, using the appropriate template and incorporate updated project information. Ensure that the final contract covers CRO activities necessary to fully support the project and that Celgene interests are safeguarded as well as country-specific requirements are reflected. Manage the contract execution process according to Celgene requirements. Negotiate contract terms in liaison with legal department. Lead competitive bidding and budget negotiations, perform benchmarking as appropriate. Advise and assist affiliates and other departments on appropriate type of agreement addressing their need. Maintain contract archive.
- Change Orders: Manage all changes to service scope ensuring timely change order finalization and implementation.
- Contract Performance: Monitor contract performance and provide issue escalation support. Maintain contracts in a database. Review project metrics and take appropriate action. Review vendor invoices.
- Vendor relationship management: Manage vendor relationships, organize and chair Project Review Meetings.
- Study Team Involvement: Participate in study teams as representative of outsourcing function. Support study managers in budget planning and forecasting.
- Process and Template Development: Support development and up-dating of department processes and tools, including contract templates. Participate in corporate initiatives.
- Business intelligence: Monitor outsourcing environment to keep current on providers and industry trends.

During all stages of activities, interact with internal customers, legal and finance departments and other functions as appropriate.

Skills/Knowledge Required:

- Degree in scientific, economic, or legal discipline, or equivalent
- 4+ yrs. as a Manager and 6+ years Pharma or 8+ years pharma-related experience or equivalent, to include at least 5 years multinational pharma outsourcing experience
- Experience with clinical research / clinical research organizations.
- Good understanding of project management principles as well as sound knowledge of contract terms and conditions, benchmarking and market analysis.
- Ability to work in a multicultural team environment and interact with a wide variety of customers. Must be able to relate effectively to people at all levels of the organization.
- Active driver, delivery-oriented.
- Proven ability to multitask
- Commercial awareness.
- Excellent English language skills, additional languages are advantageous
- Master knowledge of contract T&C and contract applicability
- Master level skills/knowledge in financial terms, budgets benchmarking, market analyses and financial negotiations
- Expert in all major outsourced service types
- Advance knowledge of drug development process
- Expert knowledge of GCP/ICH and guidelines, regulations and directives
- Computer skills, oral & written communication & multi-tasking and can identify new technologies]]>http://jobs.celgene.com/job/Neuchatel-Outsourcing-SpecialistManager-Job/1816440/181644018164402012-06-14Celgene CorporationMedical Operationsfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Senior Research Associate, DMPK
Job ID: 13041
Location: San Diego, CA
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Research
Department: DMPK - 3257


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BS degree in a biology, chemistry, or scientific discipline with at least 4 years of industrial DMPK experience or MS degree with at least 2 years of industrial DMPK experience.

Summary/Scope

We are seeking a highly motivated Senior Research Associate with strong interpersonal communication skills to conduct in vivo pharmacokinetics studies in rodents and assist in quantification of small molecules in biological matrices using LC/MS/MS in support of multiple drug discovery projects. Initially, the job responsibilities will be split 60%:30% between these two main functions. The remaining 10% will be distributed among general activities such as animal ordering, updating protocols and templates, maintaining inventories, etc.

Responsibilities will include, but are not limited to, the following:

This individual will need to have strong interpersonal communication skills and work ethics and be highly organized in order to function effectively in a fast paced drug discovery team. This person has to be proficient in handling rodents and able to prepare formulations, administer compounds via various routes, collect blood and various tissue samples, and process/extract them for analysis. Also, this candidate should be proficient in the use of software such as MS Office and graphics software and have excellent presentation and writing skills. While not expected to be an expert in the use of LC/MS/MS for quantification of small molecules in biological matrices, this person is expected to have some hands-on experience with such techniques. Experience with automatic blood sampling systems would be beneficial, but not necessary. Familiarity with pharmacokinetic concepts is a plus

Education:

BS degree in a biology, chemistry, or pharmaceutically-related discipline with at least 4 years of industrial DMPK experience or MS degree with at least 2 years of industrial DMPK experience.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/San-Diego-Senior-Research-Associate%2C-DMPK-Job-CA-92101/1818141/181814118181412012-06-14Celgene CorporationResearchfull-timeUSDstarting0BSSan Diego, CA, USJob Title: Hematology Oncology Consultant, Hematology - Phoenix
Job ID: 13040
Location: OffSite
Offsite Territory: Phoenix, AZ
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Sales
Department: Salesforce - 2502


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Bachelor’s degree in Business or Science; minimum of 5 years’ sales experience in the pharmaceutical/biotechnology industry with two years Oncology experience preferred.

The Hematology Oncology Consultant is responsible for achieving all territory sales goals through the promotion, sale and support of company products or services in his/her geographic territory. This territory encompasses Scottsdale, Phoenix and parts of northern Arizona. Major accounts include Mayo Clinic & Hospital and community hem/onc clinics.

Responsibilities will include, but are not limited to, the following:

- Direct one-to-one communication with physicians and health care professionals in support of approved product indications.
- Providing customers with assistance in the best application of products: answers all questions concerning products, with appropriate referrals where required.
- Preparing and implementing a comprehensive business plan for territory.
- Contacting prospects and explaining features and benefits of products offered, utilizing persuasive sales techniques all within the boundaries of the Celgene Promotional Policy.
- Effective collaboration with a variety of internal cross functional partners to include clinical nurse consultants, patient support specialists, marketers, account managers, advocate development managers and clinical liaisons.
- Planning and organizing promotional speakers programs in territory in partnership with Speakers Bureau vendor and advocate development managers.
- Providing support to customers in the implementation of STEPS and Rev Assist programs.
- Communicating competitive market intelligence to brand teams and management.
- Timely and accurate completion of all administrative expectations.


Skills/Knowledge Required:

- BS in Business or Science; 5+ years sales experience in pharmaceutical/biotechnology industry with at least two years of oncology sales or specialty sales preferred or proven success in medical or business field.
- Prefer individuals with the desire/ability to relocate for roles of different scope or responsibility.
- Proven track record that demonstrates top sales accomplishments.
- Demonstrated ability to understand and communicate technical clinical material clearly and effectively.
- Ability to develop critical relationships with physicians, nurses and ancillary staff within academic hospitals, clinics, and private practice facilities.
- Demonstrated understanding of oncology therapeutic area, products and marketplace.
- Demonstrated knowledge of healthcare system processes including reimbursement.
- Possesses a strong work ethic, ability to develop priorities and manage time appropriately.
- Works with all members of a team effectively.
- Integrates innovative ideas in order to accomplish corporate and individual objectives.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120406
]]>http://jobs.celgene.com/job/Phoenix-Hematology-Oncology-Consultant%2C-Hematology-Phoenix-Job-AZ-85001/1818142/181814218181422012-06-14Celgene CorporationSalesfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Maintenance Mechanic - (4 of 5) Varying Shifts
Job ID: 12836
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Plant Maintenance - 1114


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a High School Diploma or equivalent with a minimum of 2 years related experience in a regulated setting, preferably in a manufacturing environment.
- Must have a working knowledge of power transfer technology including mechanics, pneumatics and hydraulics.
- Must be familiar with machine controls including Programmable Logic Controllers, relay logic, and operator interfaces.
- Must be familiar with plant utility systems including high pressure steam, heating, ventilating and air conditioning.
- Must be familiar with metal working including machining and welding.
- Must have a clear understanding of analytical troubleshooting.

POSITION SUMMARY

The Maintenance Mechanic supports all maintenance efforts including repairs, troubleshooting, and new installations in a compliant, efficient, and effective manner. This is a rotating 2nd shift position. The hours are from 5:30pm-5:30am.

ESSENTIAL FUNCTIONS

- Responsible for maintaining all manufacturing equipment including formulation, filling and packaging equipment, and plant utility systems including, steam boilers, air compressors, heating, ventilating and air conditioning systems (HVAC), water for injection and general upkeep of the physical plant including clean rooms and building roofing.
- Responsible for implementing improvements to improve efficiency and prevent equipment obsolescence. Included are capital improvement projects like installing heating, ventilating and air conditioning systems, upgrading the water for injection system, rebuilding/upgrading filling and packaging equipment, and installing and start-up of new manufacturing and support equipment.
- Responsible for insuring the validated state of all equipment systems and facilities and compliance with all applicable cGMP, OSHA, DEC, EPA and local government regulations.
- Responsible for developing relationships with key vendors for technical support and for assistance in hardware applications.
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120409
]]>http://jobs.celgene.com/job/Phoenix-Maintenance-Mechanic-Rotating-2nd-Shift-%284-of-5%29-Job-AZ-85001/1818143/181814318181432012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Commercial Director - Mexico
Job ID: 13032
Location: OffSite
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Marketing
Department: Product Marketing - 2231


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

- BA/BS required; MBA/graduate degree strongly preferred
- 10 to 15 years of experience in the Pharmaceutical Industry (Multinational)
- Fluent in English (oral and written) is required
- Business Unit Franchise experience is required, Hematology/Oncology is preferred; Specialty Products required
- Partnership management experience is preferred

General Description:

The Commercial Director will have full responsibility for this newly created position, reporting to the Regional General Manager, Latin America and the position will be located in Mexico City, Mexico. The individual will oversee the development and implementation of the strategic business plan. The Commercial Director will manage a small but dedicated team of experts, and act as the point of contact with our local distribution partners, customers and government agencies.

Major Responsibilities:

- Ensure effective financial planning. Continually review financial performance to identify both positive and negative variances; develop action plans to address opportunities and challenges. Manage expenses to budget and deliver targeted sales and profit contribution
- Hire and manage a team of experts. Establish appropriate performance metrics. Coach, develop and retain the team. Set clear expectations, give appropriate autonomy and measure performance
- Serve as point person responsible for managing and optimizing local partnerships
- Maximize the commercial potential of our assets through the development and implementation of strategic marketing plans in collaboration with Regional Marketing and our partners
- Establish market sales and resource forecasts, initiate relevant market research projects to support the strategic brand planning process
- Lead market opportunity assessments and make recommendations on products with the most significant commercial or strategic importance for Celgene
- Oversee and lead the execution of new product and lifecycle launches
- Partner with Regional Marketing on key projects, meetings and congresses
- Establish strong relationships with customers, payers, NGOs, and government agencies
- Provide commercial input for business development opportunities
- Ensure that all business activities are in line with company policies and procedures

Ideal Experience:

- A seasoned and well-rounded pharmaceutical executive with 10 to 15 years of experience in a variety of marketing and sales roles of progressively greater scope and responsibility. The executive must have extensive commercial experience with specialty products (Hematology/Oncology preferred). The individual should have 3+ years of managing a Business Unit Franchise (Hematology/Oncology preferred)
- Successful management experience with direct responsibility for a team and a demonstrated track record of delivering top line growth and bottom line performance
- Led cross functional teams and managed partnerships
- Proven command of classic marketing disciplines and techniques. Demonstrated success in commercial planning, launching products and product life cycle management

Leadership Competencies Required:

- Demonstrates ability to lead strategically and cross functionally to drive performance
- Experience in delivering complex messages to various internal and external customers with a track record of effective presentations
- Demonstrates initiative, creativity, strategic capabilities and ability to work effectively in complex, rapidly changing environments
- Proven team player with the ability to navigate cross functionally
- Develops strategies that support Celgene’s vision, values and long-range business plans
- Communicates the company’s vision and strategies in a way that builds the understanding and commitment of others, both internally and externally
- Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics or strategies
- Pursues new initiatives and opportunities based on their fit with Celgene’s broader strategies
- Builds a culture of energy and commitment that challenges people to excel
- Attracts and selects highly talented people, based on a clear understanding of the competencies required
- Anticipates future organizational needs when selecting and developing talent
- Supports direct reports in developing effective working relationships throughout the organization
- Motivates and inspires direct reports to achieve goals; holds direct reports accountable for achieving goals
]]>http://jobs.celgene.com/job/Commercial-Director-Mexico-Job/1820823/182082318208232012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSJob Title: Senior IT Administrator (Hyperion)
Job ID: 13043
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: IT - Applications - 4162


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Summary: This newly created position will be responsible for maintaining the Hyperion applications from a technical perspective. This position will be directly reporting to the Associate Director of IT for Financial Applications.

Responsibilities will include, but are not limited to, the following:

- Technical support of Hyperion applications: EPM 11.1.2.1, Essbase, FDM, ODI
- Manage future possible implementations of HFM, HCM, HDM,
- Provide technical expertise on Hyperion application infrastructure
- Work with other teams on project delivery and support – DBAs, functional support teams, project teams, application owners, etc.
- Ensure Hyperion is fully supported by outside services vendor and prioritize workloads as necessary
- Oversee migrations using the LCM tool from one instance to another
- Diagnosis and resolution of any technical Hyperion application issues
- Work with vendor on resolution of technical issues in the Hyperion environments
- Ensure Hyperion technical documentation is in place and kept up to date
- Make recommendations on process improvement opportunities and manage approved process changes through to implementations
- Ensure daily and monthly interfaces are reviewed and issues are resolved promptly

Scope:

- Interacts with Hyperion Functional Administrator, Oracle EBS Support team, and external Hyperion managed services vendor.


Skills/Knowledge Required:

- At least 5 years experience working in a technical capacity with Hyperion Planning Systems, Essbase
- Experienced with Hyperion Technologies: ODI, FDM, HFR, EPMA and LCM
- Must have Hyperion Planning/Essbase administration skills (security, performance tuning and training)
- In addition, candidate must have knowledge of SQL and ETL methods and tools
- Experience working in a Linux/ Windows environment, shell scripting, batch scripting
- Involvement in full life cycle of project development, including requirements, design, development, testing, rollout, implementation and training
- Involvement in the installation and configuration of the Hyperion servers (web, database and report)
- Backup and recovery experience of Hyperion environments
- Ability to research, evaluate and recommend technical solutions
- Excellent time management, multi-tasking, problem resolution skills in a demanding environment supporting production systems
- Proven ability to work effectively and collaboratively with internal business and technical teams as well as vendors and consultants
- Experience working with a finance or accounting department a strong plus

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Senior-IT-Administrator-%28Hyperion%29-Job-NJ-07922/1822795/182279518227952012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Manager, Scientific Communications - Multiple Myeloma
Job ID: 13044
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Medical Affairs
Department: Scientific Communication - 3654


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- Scientific or Medical Degree (OCN, BS, MS, Pharm D, PhD, MD) required
- Publication/medical writing experience required
- Relevant therapeutic background/clinical experience preferred

Position Summary

Provides input and drives the globalscientific communications plan for company products within specified therapeutic area. Supports the efficient planning, tracking and timely dissemination of key data and demonstrates the ability to manage multiple projects. Establishes strong partnerships with medical thought leaders, investigators/authors, and internal cross-functional stakeholders. Accountable for the timelines and working closely with all key stakeholders to ensure expert input and overall quality of written, global communications, including but not limited to publications, abstracts, oral presentations, and publication summaries.

Provides appropriate direction on all projects to medical communication agencies and consultants to support their timely and cost-effective development and demonstrates ability to provide clear, concise status updates to management and internal partners. Writes a significant amount of time and demonstrates the ability to interpret scientific/clinical data and develop quality publications. Applies disease-area and product expertise to a wide variety of cross-functional projects. Contributes significantly to publication planning process, in support of the Director, Scientific Communications.

Responsibilities will include, but are not limited to, the following:

1. Provides scientific/clinical direction, manages and delivers on global scientific communications plan.
2. Manages relationships with both internal and external stakeholders and ensures expert input during development of team deliverables.
3. Establishes strong partnership with global medical thought leaders, patient advocacy groups, and professional societies to drive current and future collaborations,
4. Develops and reviews manuscripts, abstracts, posters, slide presentations, and other documents to ensure appropriate evaluation and presentation of data, methodology, interpretation, and alliance with business objectives.
5. Demonstrates ability to effectively manage multiple projects simultaneously in a timely and cost-efficient manner and demonstrates ability to provide clear, concise status updates to management and internal partners.
6. Develops content and reviews slides for clarity, accuracy, and interpretation.
7. Demonstrates disease state expertise and knowledge of current medical and/or regulatory issues related to company products.
8. Serves as internal resource on molecule and/or disease state publications to support cross-functional strategies.
9. Manages funds and resources appropriately.

Other Responsibilities

1. Conducts business in accordance with Celgene Values. Completes all assigned SOPs and training within designated timeframe and adheres to job-specific SOPs and work instructions.
2. Identifies and reports any adverse events (AEs) in accordance with Corporate policy and procedures.
3. Assists in the overall training of new Scientific Communications personnel and ensures key activities are incorporated as part of the training.
4. Attends external meetings and educational seminars to enhance therapeutic area knowledge and broaden pharmaceutical industry experience.


Skills/Knowledge Required:

- Ability to conceptually organize and analyze data, interpret, and synthesize complex clinical and non-clinical statistical reports to derive key outcomes and messages; ability to translate scientific and technical issues for diverse audiences,
- Experience or background in working within the pharmaceutical industry, awareness of compliance issues and guidelines around medical education and publications,
- Ability to work with multidisciplinary teams to ensure execution of deliverable successfully
- Excellent written, verbal and interpersonal communication skills
- Flexible, with positive attitude, strong ability to multi task, prioritize projects effectively and communicate at all levels within the company
- Some travel required to represent company at medical conferences, presentations, and other meetings

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Manager%2C-Scientific-Communications-Multiple-Myeloma-Job-NJ-07922/1822798/182279818227982012-06-14Celgene CorporationMedical Affairsfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Associate Director, Global Business Planning and Analysis
Job ID: 13046
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Marketing
Department: Product Marketing - 2231


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BS/ BA Required; MBA or advanced degree preferred

- Provide the Global Commercial Leadership team with validated global revenue forecasts and business analytics
- Provide Global Commercial Leadership team with greater visibility and transparency into performance of Celgene’s commercial operations
- Lead and facilitate information and best practice sharing within the global Commercial team and between regions and countries
- Serve as a central point of contact between Commercial sub-team leaders, Project team leaders, regional Sales Forecasting, Corporate Strategy, Business Development and Finance
- Enable seamless transfer of commercial information to Finance and Project Management

Responsibilities will include, but not limited to, the following:

- Support Global Marketing disease team leads through the development of financial models for in-line and pipeline products. Construct NPV-based models to facilitate decision making.
- Lead and manage the alignment between global revenue forecasts, clinical development plans, and product strategic plans
- Ensure country and regional in-line and pipeline product forecasts are validated, consolidated, and approved by senior management for:
- Portfolio Review
- PRC meetings
- Cross-functional long-range financial planning

- Advise on development of regional and global five-year Strategic Forecasts and ensure alignment between regions; consolidate regional assumptions and forecasts into an integrated Global five-year forecast
- Serve as a Commercial Lead on Business Development transactions and assessments
- Collaborate with Clinical, Finance, and Project Management to improve Portfolio Analysis (including the use of ROI, NPV, and other financial measures)

Skills/ Knowledge Required:

- BS/ BA required; MBA or advanced degree preferred
- Strong analytical and financial background
- Minimum five years financial analysis experience
- Minimum two years hematology or oncology marketing experience
- Outstanding communication skills (written, oral, presentations)
- Accomplished cross-functional team leader
- Ability to work well under pressure; produce high quality work with short-term deliverables

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Associate-Director%2C-Global-Business-Planning-and-Analysis-Job-NJ-07901/1825486/182548618254862012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSSummit, NJ, USJob Title: Marketing, Project Manager
Job ID: 13047
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Marketing
Department: Product Marketing - 2231


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

MBA and one of the following backgrounds required: Consulting, relevant Pharma experience, Project management experience. Fluency in English. Minimum 3 years of experience.

Main areas of responsibility of Global Disease Team Project are:

1) Project Management Office (PMO)

- Support Global Disease Teams (GDT, Hematology and Oncology) in developing and operationalizing their strategies
- Proactively communicate with relevant stakeholders to ensure timely delivery of milestones including but not limited to:
- Disease Plan
- Brand Indication Plan & Launch Plans
- Tactical Plan

- Develop and maintain a cross Global Disease Team planning calendar. Facilitate GDT meetings by setting agendas/attendee lists in cooperation with the GDT Co-Chairs, tracking outcomes and follow up action items.
- Support key GDT operations including but not limited to GDT goal setting and alignment of brand related goals across disease and with GPT’s.

- Develop an annual plan for Project Management (PM) supported projects identified in cooperation with GDT Co-Chairs, Mkt. Excellence and Global Mkt. Leadership
- Prioritize projects based on pre-set criteria, communicate PM plan to GDT’s and regions globally.
- On request provide updates to GDT Steering Committee (GDT SC) about high priority projects

- Implement, maintain and further develop suitable tools to support PM and GDT’s in delivering
- Implement and maintain project management tool to support and track agreed PM projects
- Develop roll-out plans and train relevant staff in leveraging the tool for non PM supported projects
- Further develop the tool in alignment with needs of our growing organization.

2) Facilitate Vertical and Horizontal Communications

- Support the establishment of the GDT Portal as the central source of information for GDT deliverables, material and general information. Manage content of the portal and ensure information is being communicated to appropriate stakeholders.
- Enhance cross GDT communication by supporting the organization and facilitation of regular GDT Co-chair meetings.
- Ensure regular and pro-active communication with Global Project Teams (GPT’s)

3) Tracking and measuring GDT outcomes

- Track GDT deliverables status
- Develop dashboard, track GDT tactical objectives and link to strategic imperatives
- Partner with Business Planning & Analysis on tracking strategic KPI’s in relation to forecasts

The role of the Project Manager includes, but is not limited to:

- Coordinate with GDT Co-chairs to develop strategic plans and execute tactical plans:
- Facilitate cross-functional, cross-regional communication between GDT members and other relevant stakeholders at all levels in the organization
- Maintains high-level timelines, and assures consistency and detailed timelines with input from the functional departments
- Coordinate compilation of project scope documents and plans
- Prepare monthly progress reports and ad hoc reports as required and regularly update Senior management on project status
- Ensure clarity for follow-up of GDT meetings when appropriate
- Development and support in any required Project Management tools to allow a more efficient and transparent follow up of project status
- Establish templates, processes and dashboard that allow regular reporting to senior management.
- Full accountability for the assigned project budget
- Assure that the Celgene values are demonstrated in all aspects of the team work.

Competencies required:

- Self starter, team player and strong communicator
- Strong customer focus and ability to manage client expectations
- Exceptional project management skills with ability to multitask and manage multiple small to large projects in a cross-functional, cross-regional, and cross-franchise environment and good understanding of project budgeting process.
- Strong ability to influence outcomes without direct authority and ability to hold oneself and others accountable for commitments
- Ability to balance of strategic thinking and detail focused follow up in execution in Marketing planning
- Capability to conceptualizing creative solutions by documenting them and presenting/selling them to senior management
- Exceptional problem solving, analytical and strategic planning skills
- Ability to establish rapport, persuade others and foster open communication
- Ability to adapt behavioral style to situation and customer type and to adapt approach and content depending on context and counterpart seniority
- Manage execution by tenacious follow-up and driving results
- Exceptional computer skills (MS Project, Excel, PowerPoint etc.) and familiarity with managing web-based applications
- Ability to dive deep into scientific and medical background of a disease to enable tailored PM support for different GDT needs
- Capable of managing meetings within a multicultural environment

Skills Required:

- Basic understanding of marketing planning tools and processes
- Basic understanding of marketing support functions like Market research, Business Intelligence, Congress Planning
- Medical or bio-science background enabling quick assimilation of required disease knowledge.
- Strong presentation skills

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120426
]]>http://jobs.celgene.com/job/Summit-Project-Manager%2C-Marketing-Excellence-Job-NJ-07901/1825487/182548718254872012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSSummit, NJ, USQuality Assurance
Neuchatel, Switzerland

PREREQUISITES

BS/BA in life science or relevant discipline

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

- Responsible for the review of executed batch records and ensures that all changes to the process are captured through proper change control practices.
- Responsible for the review of executed validation of drug product / API processes and ensures that all changes are captured through proper change control practices.
- Responsible for the review and archiving of the stability and release raw data, analytical documentation and reports for compliance to GMP, as appropriate.
- Responsible for the review and archiving of the method development and validation raw data, analytical documentation and reports for compliance to GMP as appropriate.
- Responsible of handling external executed batch records and documents to allow the review in the lead-time allowed
- Assists in managing the change control for equipment, methods and specifications.
- Writes new and/or revises Standard Operating Procedures and quality documents
- Circulation (to supervisor) of approval, or rejection of, any necessary or related OOS and deviation reports.
- Preparation of the Release dossier, printing the release documentation
- Participates in recommendations for continuous improvements in Quality activities
- Supports QA activities in various project Tech ops and Quality operations
- Responsible for training other QA members and instilling the awareness of quality aspects

Skills/Knowledge Required:

- BS/BA in life science or relevant discipline.
- Well Knowledge of the cGMP and their practical application in a pharmaceutical company.
- Understanding of manufacturing process and test method development requirements, both scientific and regulatory.
- Good investigational skills and QA problem solving skills with a keen eye to identify quality.
- Ability to work independently, yet effectively in a team oriented environment.
- Strong written and verbal communication skills, organizational and computer skills, and attention to detail are essential.
- Capability to pay attention to detail.
- Ability to work independently and within a multicultural team.
- Sense of responsibility, reliability.
- Ability to handle multiple tasks while working against pressures of deadlines.
- Sense of team spirit, initiative and service.]]>http://jobs.celgene.com/job/Neuchatel-Associate-QA-Analyst-Job/1825488/182548818254882012-06-14Celgene CorporationQuality Assurancefull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Associate Buyer/Planner
Job ID: 13048
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Technical Operations - 1105


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- 2+ years experience as a purchasing/planning professional
- Associate’s degree in Business Management/Business Administration or a related field preferred with two to four years relative experience.
- Prefer experience with enterprise ERP systems, SAP and Oracle specifically.
- Must be able to present data and analyses in an organized, clear, and concise manner.
- Must possess excellent oral, written, and interpersonal skills.
- MS Excel knowledge is a must.
- APICS (American Production and Inventory Control Society) or ISM (Institute for Supply Management) certification preferred.
- An equivalent combination of education and experience may substitute.

POSITION SUMMARY

The Associate Buyer/Planner is responsible for assisting in interpreting and analyzing demand requirements and assisting in planning and procuring one or more of the following: API, Raw Material, Components, Operating Supplies, Equipment, and Maintenance supplies to support the manufacturing facility located in Phoenix.

ESSENTIAL FUNCTIONS

- Works with planner to determine optimal inventory levels and allocations needed to achieve manufacturing goals.
- Assist in Resolving material shortages before they affect production.
- Assist in order discrepancies to facilitate the receipt of goods (I.e. missing certificates, packing slips).
- Help Facilitate the return of merchandise to supplier due to quality issues, delivery terms, etc.
- Analyzes functional activities and processes and recommends actions for continuous improvement and cost effectiveness (e.g., revisions to a SOP, documentation of a materials procedure, enhance internal demand requirement procedure to assure proper notification to internal staff).
- Manage and monitor uniform program - Sterile and non-sterile garments (i.e. Invoice discrepancies, return of damaged garments, fittings for new hires).
- Responsible for filing and maintaining departmental documents (MCS’s, Vendor Files, W-9’s, etc…)
- Responsible for assisting in new vendor activities (Vendor set-up in ERP systems).
- Performs other duties, ad hoc analyses, and special projects as assigned by manager from time to time.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Associate-BuyerPlanner-Job-AZ-85001/1828038/182803818280382012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Senior Controls Engineer
Job ID: 13049
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Plant Engineering - 1113


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a Bachelors degree in Engineering or related science from an accredited college or university with a minimum of 5-7 years related experience in a pharmaceutical or engineering environment.
- An equivalent combination of education, experience, and training may substitute.
- Must have a working knowledge of The National Electric Code, High voltage up to 460 volts, machine controls including Programmable Logic Controllers (PLC’s), relay logic, motor controls (VFD’s and servo), temperature and pressure controls including PID, thermocouples, RTD’s and transducers and operator interfaces.
- Must be proficient in reading electrical schematics, ladder logic, and P&ID drawings.
- Must have a clear understanding of analytical troubleshooting/problem solving and excellent communication skills.
- Proficiency in MS Office, MS Project, and AutoCAD.

POSITION SUMMARY

Provide engineering (design) and technical support for multiple aseptic production lines and production support functions to ensure the efficient production of a quality product. Responsible for acting as a technical resource to the engineering, maintenance, and validation departments. This position will be responsible for controls systems design, specification, programming, simulation and testing, troubleshooting, repairs, start-up assistance, and project documentation as required. Must have proven experience in PLC logic and programming.

ESSENTIAL FUNCTIONS

- Maintain all manufacturing/packaging equipment, plant utility systems, and the physical plant including all equipment controls and electrical distribution systems.
- Research the development, design, layout, building, testing, troubleshooting, repairs, and improvement of all manufacturing equipment and plant utility systems.
- PLClogic and programming with any of the following PLCs: Allen Bradley, Modicon, GE Fanuc, Siemens, AutomationDirect, Mitsubishi, Omron, Aromat, Toshiba, etc.; and HMI or SCADA programming and configuration of any of the following software packages Wonderware, Rockwell, Intellution, GE Cimplicity, Ci-Tech, Iconics, Siemens, US Data, etc…
- Panel design and layout, bill of materials generation, and wiring schematic development.
- Ability to develop and implement standard engineering practices.
- Provide detailed documentation upon project completion.
- Implement improvements to improve efficiency and prevent equipment obsolescence.
- Ensure individual compliance with the EU, FDA, JP, and DEA regulations, cGMPs and applicable department programs, including training, documentation, and standard operating procedures.
- Ensure the validated state of all equipment, systems and facilities and compliance with all applicable cGMP, FDA, EU, JP, OSHA, DEA, EPA and local government regulations.
- Supervise the daily activities of up to 5 plant electricians and mechanics.
- Develop relationships with key vendors for technical support and for assistance in hardware applications.
- This person will be the project technical lead and may be responsible for some project management activities.
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Senior-Controls-Engineer-Job-AZ-85001/1828039/182803918280392012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USLegal
Neuchatel, Switzerland

PREREQUISITES

A minimum of 5years experience in the legal field as a qualified lawyer.

Pharmaceutical law work experience with a pharmaceutical company or law firm.

Fluent English written and spoken

Valid Swiss working permission or EU Citizenship required

Job Description:

- Preparing, reviewing and negotiating R&D agreements of all types (Research Collaborations, Phase I- III clinical trials and Phase IV post-marketing studies, Cooperative Group Studies, IITs), including drafting and evaluating non-standard contractual provisions.
- Providing legal advice on R&D and clinical compliance regulations.
- Providing legal support on legal compliance, including providing training presentations and legal advice related to interactions with HCPs, educational and promotional materials and events, procedures and policies governing HCP relationships, grants, and collaborations with patient organizations.
- Working with cross functional clinical development and disease teams on matters relating to regulatory requirements for investigational and approved products, clinical trials, drug safety issues, labeling and life cycle management.
- Participate in special projects of the corporation and affiliates in the region, working with internal and external stakeholders (including third parties and outside counsel as necessary). The candidate will be part of the centralized Legal Department of a multinational pharmaceutical company, serving the legal needs of the international (ex-US) regions of the company to a broad variety of stakeholders, including medical, clinical, drug safety, compliance, regulatory and commercial marketing departments both at the affiliate and central levels.

Skills/Knowledge Required:

- Broad based knowledge of general corporate law and regulatory law. Knowledge of EU and Member State laws and regulations impacting the pharmaceutical industry. Asia-Pacific experience a plus.
- Work experience with laws and regulations related to biopharmaceutical research and development and Healthcare Codes of Conduct, including the Clinical Trials Directive, Data Privacy legislations, Good Clinical Practices, guidelines related to safety reporting, compassionate use and human subject protection.
- Strong contract drafting and negotiation skills and experience with various agreements within the assigned area of responsibility (including, but not limited to, Laboratory Services Agreements, Material Transfer Agreements, Research Agreements, Research Grants, Phase I-III Clinical Trials and post-marketing studies, IITs and other R&D collaborations)
- Familiarity with matters such as intellectual property, access to data, ownership of data and specimens, patient privacy, liability, indemnification, confidentiality.
- Ability to identify and analyze issues and take initiative.
- Ability to prioritize obligations and adapt to a fast-changing multinational environment.
- Strong communication and interpersonal skills.
- Ability to work as a team player both within the legal department and within the corporation.
- Strong identification with Celgene’s values.

Qualification and experience:

- A minimum of 5years experience as a qualified lawyer.
- Work experience in a multinational pharmaceutical or healthcare company or in the life sciences department of a law firm.
- A degree in biological sciences is a plus.
- Ability to work with different cultures and different types of projects.
- Excellent written and oral communication skills in English. Other languages a plus.]]>http://jobs.celgene.com/job/Neuchatel-Legal-Advisor-Job/1828040/182804018280402012-06-14Celgene CorporationLegalfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Director, State/Government Relations - Central U.S.
Job ID: 13053
Location: OffSite
Offsite Territory: Chicago, IL
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Other
Department: Corp Affairs&Strategic Mkt Acc - 4111


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Required: Bachelor’s Degree; minimum ten years in Government Relations (pharma industry preferred) or equivalent lobbying experience. Ability to travel as required (50%-70%).

The State Government Relations Director position is a field based position. This position will cover the Central Region, which includes: IL, TX, MO, NM, OK, KS, IA, MN, ND, SD, NE and LA. (THE INCUMBENT MAY RESIDE IN ANY OF THESE STATES.)

Responsibilities include:

- Directing activities with state legislators, regulators and health agency personnel in a multi-state geographic area of the US to ensure patients’ needed access to therapies, optimize Celgene’s business environment and earnings potential, and secure reimbursement for Celgene products,
- Analyzing and monitoring proposed state legislation and/or regulations in his/her multi-state territory that would impact Celgene’s business interests
- Communicating directly with company stakeholders on state government affairs and legislative issues relating to Celgene’s business interests.
- Developing and maintaining strategic relationships with elected state officials, legislators, regulators and state agency officials.
- Recommending and developing prudent courses of action based on his/her complete analysis of legislative proposals that are of major consequence to Celgene and, as appropriate, execute direct lobbying activities with legislators and health agency staff.
- Securing and protecting access for Celgene products via State Medicaid.
- Being an active member and representing Celgene on relevant regional/state legislative and other trade association task forces that are organized under the auspices of PhRMA and BIO and maintaining strong working relationships with these trade association partners.
- Promoting Celgene as a leading biopharmaceutical company specializing in oncology products that can be a first-tier resource with elected public officials, patient advocacy groups, medical and business organizations that have major influence in the development of prudent healthcare policy.
- Ability to travel as required (50%-70%).

Experience & Knowledge

- Bachelor’s Degree (Master’s Degree or other post-graduate degree preferred)
- Minimum ten years in Government Relations (pharmaceutical industry preferred) or equivalent lobbying experience
- Understanding of states’ political environment
- Understanding of government payers, particularly Medicaid
- Ability to assess situations and recommend plans of action positively impacting our patients and Celgene stakeholders
- Knowledge of the impact of the newly-enacted health care reform law on state governments
- Understanding of role and impact of local and national trade associations
- Strong relationship-building skills
- Proven political skills and aptitude
- Strong attention to detail
- Strong financial acumen
- Strong written and oral communications
- Excellent organizational skills
- Effective negotiation skills

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Chicago-Director%2C-StateGovernment-Relations-Central-U_S_-Job-IL-60290/1830413/183041318304132012-06-14Celgene CorporationOtherfull-timeUSDstarting0BSChicago, IL, USJob Title: Director, State/Government Relations - Northeast U.S.
Job ID: 13052
Location: OffSite
Offsite Territory: Boston, MA
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Other
Department: Corp Affairs&Strategic Mkt Acc - 4111


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Required: Bachelor’s Degree; minimum ten years in Government Relations (pharma industry preferred) or equivalent lobbying experience. Ability to travel as required (50%-70%).

The State Government Relations Director position is a field based position. This position will cover the Northeast Region, which includes: NJ, NY, MA, PA, WV, ME, NH, CT, VT, RI and DC. (THE INCUMBENT MAY RESIDE IN ANY OF THESE STATES.)

Responsibilities include:

- Directing activities with state legislators, regulators and health agency personnel in a multi-state geographic area of the US to ensure patients’ needed access to therapies, optimize Celgene’s business environment and earnings potential, and secure reimbursement for Celgene products,
- Analyzing and monitoring proposed state legislation and/or regulations in his/her multi-state territory that would impact Celgene’s business interests
- Communicating directly with company stakeholders on state government affairs and legislative issues relating to Celgene’s business interests.
- Developing and maintaining strategic relationships with elected state officials, legislators, regulators and state agency officials.
- Recommending and developing prudent courses of action based on his/her complete analysis of legislative proposals that are of major consequence to Celgene and, as appropriate, execute direct lobbying activities with legislators and health agency staff.
- Securing and protecting access for Celgene products via State Medicaid.
- Being an active member and representing Celgene on relevant regional/state legislative and other trade association task forces that are organized under the auspices of PhRMA and BIO and maintaining strong working relationships with these trade association partners.
- Promoting Celgene as a leading biopharmaceutical company specializing in oncology products that can be a first-tier resource with elected public officials, patient advocacy groups, medical and business organizations that have major influence in the development of prudent healthcare policy.
- Ability to travel as required (50%-70%).

Experience & Knowledge

- Bachelor’s Degree (Master’s Degree or other post-graduate degree preferred)
- Minimum ten years in Government Relations (pharmaceutical industry preferred) or equivalent lobbying experience
- Understanding of states’ political environment
- Understanding of government payers, particularly Medicaid
- Ability to assess situations and recommend plans of action positively impacting our patients and Celgene stakeholders
- Knowledge of the impact of the newly-enacted health care reform law on state governments
- Understanding of role and impact of local and national trade associations
- Strong relationship-building skills
- Proven political skills and aptitude
- Strong attention to detail
- Strong financial acumen
- Strong written and oral communications
- Excellent organizational skills
- Effective negotiation skills

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Boston-Director%2C-StateGovernment-Relations-Northeast-U_S_-Job-MA-02108/1830414/183041418304142012-06-14Celgene CorporationOtherfull-timeUSDstarting0BSBoston, MA, USJob Title: Senior Quality Systems Analyst, Investigational Materials Supply Chain
Job ID: 13051
Location: Basking Ridge, NJ -110
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Investigator Mat. Supply Chain - 3611


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BA/BS Life sciences / computer science / Management Information
Systems PLUS 7+ years clinical technologies validation experience OR Equivalent. Preferred experience with IVRS and electronic management of clinical supplies distribution.

Scope

This position is mainly responsible for the development and implementation of the Quality Assurance (QA) and User acceptance Program (UAR) for IVR and IMSC systems in support of clinical trials. The incumbent will provide leadership and have final responsibility for all QA and test activities within assigned application areas that support key business processes and initiatives. This will require managing multiple concurrent projects on different application systems.

Responsibilities include, but are not limited to, the following:

- Develop the Quality Management Plans and Test Strategies for all IMSC projects assigned
- Responsible for User Acceptance Test (UAT) approach, documentation and management
- Responsible for determining acceptance criteria of systems
- Define the UAT structure for developing, organizing and maintaining test cases
- Maintain all Test Assets generated by a project. Assist the IMSC IVRS Central management Team in developing and coordinating UAT plan for each system
- Review and Approve all project Test Deliverables and design specs
- Collect, analyze and report on quality metrics for all projects, and vendors
- Establish and maintain a quality monitoring plan for live systems
- Participate as needed on the IMSC IVRS Central management Team to ensure that members understand the quality management plan, test strategy, and quality processes
- Provide training on UAT processes and associated tools when necessary
- Gain sponsorship buy-in for quality initiatives such as promoting ongoing training and implementing best practices throughout the project
- Ensure sufficient infrastructure to support quality initiatives
- Assist with the development of Quality Assurance and UAT Standards, Processes, Procedures, Methodologies, and Practices to support IMSC areas of responsibility
- Collaborate and assist in management of vendor activities.
- Independently makes decision to ensure the effective resolution of issues as they develop


Skills/Knowledge Required:

- BA/BS Life Sciences / Computer Science or related technical area / Management Information Systems PLUS 7 + years clinical technologies experience with direct experience with IVRS validation OR Equivalent. Preferred experience with IVRS (validation and design) and clinical supplies chain management
- Demonstrated skills in management of multiple projects simultaneously.
- Familiarity with legislative and regulatory requirements with respect to investigational drugs.
- Knowledge of use case methodology
- Demonstrated excellent teamwork and collaboration skills
- Ability to lead and motivate employees
- Knowledge of the software validation process in an FDA regulated environment
- Knowledge and ability to apply FDA 21 CFR Part 11requirements

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Basking-Ridge-Senior-Quality-Systems-Analyst%2C-Investigational-Materials-Supply-Chain-Job-NJ-07920/1830415/183041518304152012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSBasking Ridge, NJ, USJob Title: Order Management Specialist
Job ID: 13064
Location: Basking Ridge, NJ -110
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Logistics - 1201


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Must have High School diploma, college degree preferred

Responsibilities will include, but are not limited to, the following:

- Creation of phone, email, and faxed product orders in the appropriate database
- Perform the release of all product orders to the appropriate distribution center for shipping upon completed verification of shipment eligibility
- Verify pharmacy product eligibility for risk managed product orders using the risk management system
- Verification of valid ship-to licensing (inclusive of name, address and license expiration) for every product order
- Documenting and submitting orders that require outbound follow up
- Creating Return Material Authorizations for direct and third party returns
- Creation and mailing of patient return authorizations and outbound packages
- Weekly rotation of duties – Order Verification, Phone Orders, and OM Mailbox/Fax management
- Processing and appropriate inter-departmental notification / escalation of product complaints
- Identify inaccurate and/or incomplete orders and follow up with the wholesaler/pharmacy to resolve
- Complete product pedigree requests
- Required to maintain knowledge of company products
- Responsible for a general understanding and proficiency in all database functionality
- Assist with special projects as needed
- Attend assigned training as scheduled and complete quizzes as required
- Ability to effectively communicate with both internal and external customers
- Maintain daily quality standards of 99% error free data entry


Skills/Knowledge Required:

- Must have a high school diploma
- Excellent attention to detail
- Ability to work independently
- Must complete all job responsibilities in an accurate and timely manner
- Excellent verbal and written communication skills
- Proficiency in Microsoft Office Suite (Excel, Outlook, Power Point, Word)
- Prior Oracle experience preferred

Data entry experience in a telecommunications environment preferred

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Basking-Ridge-Order-Management-Specialist-Job-NJ-07920/1842518/184251818425182012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSBasking Ridge, NJ, USJob Title: Director of US Health Policy and Reimbursement
Job ID: 13066
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Pricing & Market Access
Department: Pricing & Market Access - 4105


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Required Education & Experience

- Bachelors' degree health economics, health policy or related field required. Advanced degree preferred (Public Policy or related discipline a plus).
- 8-10 years experience in health policy, government affairs, reimbursement, or health economics/outcomes research in Medical Device, Pharmaceutical or Healthcare Industry.
- Prior experience representing a company to the CMS or other government health agencies is desired.
- Successful candidate must demonstrate excellent communication and collaboration skills, and a high level of competence in reimbursement and health economics of pharmaceuticals.
- Experience in developing corporate positions on policy issues and policy work plans and communicating these to senior management.
- Experience in dealing with US federal and state government agencies, such as Centers for Medicare and Medicaid Services, including their regulatory processes and finance issues and processes.
- Experience with reimbursement and market access conditions and health policy trends in international markets a plus.

This position will report to VP, Strategic Market Access and Policy

Overview of position
This position will analyze, assess, and communicate key U.S. health care policies that may impact Celgene in both the short and long-term. The position will focus on the impact of public and private sector trends on Celgene with respect to patient access and reimbursement. The Director of U.S. Health Policy will play an integral role in helping internal and external customers understand the dynamic health care environment, while developing strategies to assess, impact and shape policies impacting Celgene and the patients we serve.

Responsibilities will include, but are not limited to, the following:

- Monitor and assess U.S. public policy environment, including specific policies that impact coverage and reimbursement for Celgene products within all payer environments (Medicaid, Medicare and private payers)
- Effectively manage internal cross-functional teams to facilitate information flow throughout the organization on all U.S. public policy issues.
- Closely collaborate with Celgene Federal Government Relations, State Government Relations, Patient Advocacy, as well as Celgene therapeutic area franchises, U.S. Medical Affairs and Clinical, Regulatory Affairs, Market Access and other internal customers.
- Coordinate development of policy positions and appropriate policy materials to ensure successful implementation of work plans on all priority U.S. policy issues.
- Develop strategy and educational materials on key U.S. public policy issues and communicate on public policy positioning and priorities to internal and external audiences.
- Develop and articulate effective reimbursement policy and strategies which integrate and support business objectives that are impactful, executable, easily communicated, and clinically/financially supported.
- Develop and implement policies to drive optimal coverage and payment for products/indications in our portfolio and pipeline.
- Drive health policy initiatives which facilitate effective use of our products.
- Assist in the development and execution of comparative effectiveness research/outcome studies to reinforce product value for economic stakeholders.
- Build relationships with both internal and external stakeholders to support the company’s policy positions and priorities.
- Develop written materials (e.g. Policy Issue Briefs) and presentations on health policy and reimbursement issues.
- Ability to travel (about 20%).

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Director-of-US-Health-Policy-and-Reimbursement-Job-NJ-07901/1844385/184438518443852012-06-14Celgene CorporationPricing & Market Accessfull-timeUSDstarting0BSSummit, NJ, USJob Title: Technician, QC Lab Services - 1st Shift
Job ID: 13067
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Quality Ops
Department: Quality Control - 1103


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires an Associates degree in life Sciences from an accredited college or university with a minimum of 0-1 year related experience in a regulated laboratory, preferably in a pharmaceutical laboratory environment.
- An equivalent combination of education, experience and training may substitute.

POSITION SUMMARY

The Laboratory Technician performs cleaning of laboratory glassware, general housekeeping of the laboratory, receiving and stocking of laboratory reagents and provides basic support in the QC Control Center. The incumbent assures individual compliance with the DEA and FDA regulations, cGMP’s and applicable department programs, including training, documentation, standard operating procedures, and Abraxis policies and procedures. Performs shift work as assigned. Approximate shift hours - 1st Shift: 6:00 am – 2:30 pm; 2nd Shift: 2:00 pm – 10:30 pm; 3rd Shift 10:00 pm – 6:30 am. Daily work hours may occasionally extend to up to 12 hrs. on an as-needed basis.

ESSENTIAL FUNCTIONS

- Perform responsibilities in accordance with organization’s policies and procedures.
- Cleans laboratory glassware per departmental procedures.
- Receives and stocks laboratory reagents per departmental procedures.
- Performs periodic audits of reagents and standards per departmental procedures.
- Maintains appropriate documentation as required by laboratory SOPs.
- Complies with good housekeeping and safety practices.
- Performs basic QC control center duties as assigned.
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Technician%2C-QC-Lab-Services-1st-Shift-Job-AZ-85001/1849306/184930618493062012-06-14Celgene CorporationQuality Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Associate Director / Director, Scientific Lead, Medical Affairs - MDS & AML
Job ID: 13069
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Medical Affairs
Department: Medical Affairs Leadership - 3609


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Summary:

The Scientific Lead, Solid Tumors will support Medical Affairs Global Disease Leadership in Heme/Solid Tumors. This function will assist the Global Medical Affairs Disease Lead-Heme/Solid Tumors to effectively lead and implement the Global Medical Affairs Disease Strategy. This function will be accountable for working closely with Disease Lead, Heme/Solid Tumors to deliver enhanced efficiencies and quality around tactical deliverables, decision making, as well as internal and external meetings with customers.

Responsibilities will include, but are not limited to, the following:

Leadership responsibilities: strategic and tactical

- Assist GMADL/GDT co-chair with all GDT responsibilities
- Represent US MADL on GDT
- Represent Medical Affairs in cross functional teams/meetings, eg Project Teams, Clinical Subteams, Global Congress Steering Cmt,
- Collaborate with all Disease representatives in Medical Affairs on Disease strategy and tactics
- Support/lead Medical affairs cross-functional working groups
- Perform, as needed, research and analytics and provide recommendations to support quality medical decisions regarding clinical research, consultancy, and internal planning.
- Conduct research and provide directed analytics and valuable backgrounders, as well as provide recommendations to guide Medical Leadership IIT decisions.
- Represent company at professional meetings, congresses, and local symposia.

Deliverable responsibilities: strategic and tactical

- Assist with Global and US Disease Strategy and Plans
- Track priority Med Affairs tactics in Disease Plans
- Partner with Sci Comm on developing Disease publication strategy, gap analysis, key messages
- High quality scientific/clinical input and review of:
- Disease strategy/plans,
- Abstracts, posters, slides, manuscripts in disease area
- Educational materials in disease area including slides, webcasts, etc
- LOIs/ IIT protocols in disease area
- KOL Steering cmt meeting objectives, materials
- CTB, booth panels
- Med info letters
- CDPs, Commercial Brand plans, Integrated Disease Plans
- ORQs in disease area
- Scientific educational grant requests
- Patient advocacy grant requests
- Assist with scientific searches, data summaries, preparation for site visits/corporate visits/payor presentations

Actively engage/interact with key stakeholders including:

Internal:

- Med Aff partners in disease area
- Global Medical Affairs Leadership
- Marketing
- Market Access
- Clinical
- BioStats
- Translational
- Regulatory
- Project Leadership

External:

- PIs, KOLs
- Global steering Cmt
- Scientific Advisory Boards (Regsitries)
- Advocacy groups
- Coop groups


Skills/Knowledge Required:

- RN/PhD/PharmD preferred.
- Minimum 5 years pharma/biotech industry or related experience.
- Experience in Medical Affairs and/or Clinical Development preferred.
- Proficient in critical data review and interpretation
- Strong Leadership skills.
- Able to lead in matrix organization.
- Excellent written and oral communication skills.
- Travel required

Competencies Required

- Leadership, Technical / Professional Knowledge, Planning and Organizing, Building Positive Working Relationships, Decision Making, Negotiation, Communication, Initiating Action, Customer Focus, Follow up, and Ongoing Listening and Learning
- Data handling/analysis-clinical trials and publications

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Associate-Director-Director%2C-Scientific-Lead%2C-Medical-Affairs-MDS-&-AML-Job-NJ-07901/1852232/185223218522322012-06-14Celgene CorporationMedical Affairsfull-timeUSDstarting0BSSummit, NJ, USJob Title: Sr. Director, Statistics
Job ID: 13063
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: BioStats
Department: BioStats - 3605


About Celgene

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

- Completed Ph.D. or MS in statistics.
- Experience in clinical drug development required - 15 years for Ph.D., 17 years for MS.
- At least 8 years direct employee management experience required.
- Thorough understanding of regulatory guidance and statistical methodology as applied to pharmaceutical development.
- Ability to identify, evaluate and implement innovative statistical methods, which will improve the company drug development process.
- Direct experience of regulatory submissions and follow-up support during the approval process.
- Experience in immunology and inflammation is preferred.


Summary

Reporting to the VP, Biostatistics and Programming, this individual will lead the Biostatistics function within the Immunology and Inflammation franchise of Celgene Corporation. The individual will be responsible for statistical input to development strategies, and effective implementation plans to support product development objectives in a rapidly growing, global organization. The successful candidate will provide expertise and guidance in collaboration with other groups broadly across the organization in clinical study design and institute best practices with regard to planning, execution, and interpretation of clinical projects and studies.

Responsibilities will include, but are not limited to, the following:

1. Strategic and managerial responsibilities for Biostatistics within the Immunology and Inflammation franchise of Celgene.
2. Oversee the statistical support for the development of multiple compounds and/or therapeutic areas.
3. Provide representation, as needed, on cross-functional clinical development teams in support of product development and registration.
4. Supervise statisticians responsible for individual program and trial support. Ensure quality study designs, preparation of statistical analysis plans, analyses, and clinical study reports.
5. Interact and manage KOLs/CROs and represent the company in external scientific forums including communication with worldwide regulatory agencies.
6. Provide administrative support including resource planning, managing, performance review, SOPs development and training. Contribute to the vision, strategy, and planning towards the development of statistical functional capabilities.
7. Represent the company in interfaces with regulatory agencies globally
8. Responsibility for the creation of optimal work processes including the creation/maintenance of SOPs, process flows, templates, and working practices.

Minimum
Skills/Knowledge Required:

- Completed Ph.D. or MS in statistics.
- Experience in clinical drug development required - 15 years for Ph.D., 17 years for MS.
- At least 8 years direct employee management experience required.
- Thorough understanding of regulatory guidance and statistical methodology as applied to pharmaceutical development.
- Ability to identify, evaluate and implement innovative statistical methods, which will improve the company drug development process.
- Direct experience of regulatory submissions and follow-up support during the approval process.
- Demonstrated skills and experience in statistical functional management within global R&D organizations.
- Extensive experience in clinical operations and interaction with regulatory agencies for NDAs, FDA Advisory Committee, and European equivalents.
- Excellent skills in Power Point, Microsoft Excel, Microsoft Project Management; and various statistical software.
- Excellent interpersonal, communication, writing and organizational skills.
- Demonstrated ability to work in a team environment and with other departments.


Preferred Skills/Knowledge:

- Experience in immunology and inflammation is preferred.


Equal Employment Opportunity

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Sr_-Director%2C-Statistics-Job-NJ-07901/1852234/185223418522342012-06-14Celgene CorporationBioStatsfull-timeUSDstarting0BSSummit, NJ, USJob Title: Director, Public Relations
Job ID: 13073
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Communications / PR
Department: Corporate Communications - 4126


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- BA/BS required, preferably in public relations, journalism, communications or healthcare.

The Director of Public Relations is responsible for cultivating and maintaining positive perception of Celgene and its initiatives across a broad range of stakeholders including media, legislators, advocates, investors and the general public. As part of the Corporate Affairs team, the Director of Public Relations will work with executive staff, government affairs, advocacy relations, disease and product teams and market access to define and execute our overall global public relations strategy. The PR Director will be a key information source for media contacts requesting data and insights, and will manage the development, implementation and coordination of public relations initiatives, with the goal of gaining recognition in the market for our products and establishing our thought leadership throughout industry, government, public and financial venues.

Primary Responsibilities:

- Serve as main information source for all media contacts requesting data and insights
- Scan global environment for key issues affecting the company’s image, products and plans, alerting management to emerging issues and potential impact to the brands and products in development, executing PR plans to effectively address and manage such issues
- Work closely with global disease and product teams to develop creative and integrated programs to support product introduction, disease awareness, as well as scientific and thought leadership
- Writes and/or edits such information media as: Press releases, bulletins, flyers, ad copy, speeches, reports, brochures, position papers, feature articles and related publicity materials, and website management
- Establish processes to manage and analyze information flow – both as communications from the company and coverage across multiple targets
- Work with partners and public relations agencies to develop, solicit and place targeted communications to secure key mentions
- Help to promote key public initiatives internally
- Arrange, facilitate and manage external relations campaigns around major medical meetings
- Help shape public perception around government affairs initiatives that have the potential to affect Celgene business
- Work closely with key stakeholders globally, including advocates, KOLs, COEs and patients to expand important medical information to patient networks
- Provide support to investor relations around key financial initiatives, including quarterly earnings reports
- Direct program to facilitate media briefings with key company spokespeople and provide appropriate interview training (including key messages) in advance
- Develop and implement short-and long-term global strategies for proactive media relations programs to favorably position opportunities within the trade, business and financial press, as well as social media and other channels.
- Manage an effective global crisis and issues management program that identifies early warning scenarios that could be distracting or disruptive to the business.
- Develop and cultivate relationships with internal business leaders to maintain and ensure consistency of messaging among all audiences.
- Leverage and improve existing communication channels to create a shared understanding of priorities, strategies and goals.

Requirements:

- At least 10 years public relations experience, preferably in the healthcare/biopharmaceutical space with an emphasis on corporate versus agency side experience – Pharma/Biotech experience beneficial
- Understanding of the general healthcare and biopharma products landscape and issues (i.e. reimbursement, safety)
- Demonstrated ability to manage multiple high-profile projects (agency experience helpful)
- Significant experience in media relations and issues management, spokesperson training, special events and strong journalistic writing skills
- Possess well-developed relationships with members of the media
- Success representing public relations on cross-functional teams developing strategies and tactics for integrated plans
- Experience translating advanced scientific concepts to relatable examples for varying audiences
- Experience working with and managing public relations and other agencies/vendors
- Experience developing and managing charitable giving, volunteerism, community relations and/or corporate social responsibility programs

Personal Attributes:

- Entrepreneurial and passionate about their work and opportunity to contribute to the growth and success of the company;
- Disciplined in ongoing reading, monitoring, research and analysis of biopharma industry news and happenings;
- Excellent presentation skills, both verbal and written, including the ability to effectively and succinctly communicate complex concepts;
- Team player with strong interpersonal skills;
- Ability to work with a high degree of independence;
- Able to work well with international cultures and diversity;
- Strategic orientation; and possess sound judgment.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120424
]]>http://jobs.celgene.com/job/Summit-Director%2C-Public-Relations-Job-NJ-07901/1854731/185473118547312012-06-14Celgene CorporationCommunications / PRfull-timeUSDstarting0BSSummit, NJ, USJob Title: Director, Shared Services Americas Lead
Job ID: 13074
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Other
Department: Corporate Controller - 4130


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Education: BA or BS in Accounting / Finance. CPA and/or MBA strongly preferred.

Experience: 15+ years of Accounting / Finance experience, with at least 5 years managing Shared Services functions. Experience with a biotechnology and/or pharmaceutical company strongly preferred.

Responsibilities will include, but are not limited to, the following:

Shared Services Operational Oversight

- Overall responsibility for Shared Services Americas and leading team in all processes included within the US Shared Services Center (SSC) as well as practical hands on experience to perform key tasks as necessary.
- Liaise with International SSC personnel and continue to globalize processes and leverage best practices in the Shared Services space.
- Develops and implements annual operating plans, with financial objectives consistent with the long-range strategic plans and initiatives to support efficiency and cost reduction.
- Work closely with cross functional teams to identify and implement opportunities for efficiencies (including the ERP project team).
- Provides directional guidance to management team for all process areas included in the scope of Shared Services Americas. Current process scope includes Accounts Payable (AP), Purchasing Operations, ravel & Entertainment (T&E), Accounts Receivable (AR), Record to Report, Payroll, Travel Management, Aggregate Spend Finance support, and Contract Compliance.
- Continues to establish goals and performance metrics for Shared Service Americas.
- Continues to establish Global Key Performance Indicators (KPIs) to align with delivery of desired service level to the business (in conjunction with Shared Services International). Provides Senior Management in Finance and supported units with regular communication of performance against desired service levels.
- Partners with Senior Management for the various business functions to understand desired service levels, metrics, establish processes and procedures to deliver this service level, and provide input and guidance on process optimization and remediation.
- Creates and maintains Global Shared Services service delivery model, operating model, process framework, leadership, and governance (in conjunction with Shared Services International).
- Responsible for policies, standard operating procedures (SOPs) and controls for all Shared Services Americas process areas. These policies have broad-based impacts across the company including how vendor payments are initiated and approved, how employees manage their travel and entertainment expenditures, and how salary and wages are delivered to employees.
- Represents Finance team on key committees as designated by the Corporate Controller.
- Implements, directs, and oversees service center operations, including the seamless integration of day-to-day delivery from multiple service functions, coordinating large scale issue resolution, driving strategic improvement, managing and developing leadership, ensuring a motivated, customer-oriented organization, maintaining relationships with customers, and expanding services as appropriate.
- Creates a culture of performance excellence for the ~ 40 team members within Shared Services Americas.

Shared Services Vision, Strategy & Leadership

- Responsible for the design and implementation of the company’s shared services strategy and ensuring that it is in alignment with the overall company strategy.
- Continue to establish strategy, organization structure, and governance for identified processes incorporated into the Shared Services Americas scope.
- Continue to design, develop, and execute a business strategy for expanding the Shared Services to appropriate other areas of service.
- Exercises fiscal oversight for the shared services organization.
- Provides thought leadership to influence corporate strategy relative to shared service capabilities and trends. Establishes the vision and mission for shared services in support of the company strategy.

Behavioral Competencies:

- High sense of urgency and ability to identify creative solutions to advanced, time sensitive problems by balancing achievement of process objectives with practical considerations.
- High degree of integrity with courage and commitment to do the right thing no matter what the situation
- Excellent negotiation and collaboration skills
- Strong customer service focus, with a drive to ensure that we exceed the expectations of our customers
- High degree of organizational agility, able to handle sensitive issues with prudent discretion across all levels of the organization
- Strong ability to implement best practices in back office operations; commitment to driving competitive advantage while managing costs, improving quality, and managing risks
- Commitment to delivering quality results and overcoming obstacles and challenges in a time-sensitive environment
- Ability to juggle and prioritize multiple work streams while remaining calm and effective under pressure

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120424
]]>http://jobs.celgene.com/job/Berkeley-Heights-Director%2C-Shared-Services-Americas-Lead-Job-NJ-07922/1854732/185473218547322012-06-14Celgene CorporationOtherfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Senior CRA, Atlanta, GA or Tampa, FL
Job ID: 13072
Location: OffSite
Offsite Territory: Atlanta, GA
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Clinical Operations - 3603


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

- BS / BA / RN; scientific degree preferred
- 8+ yrs experience in the pharmaceutical/medical industry

OR

- 3+ yrs at Level II or Equivalent

Summary/Scope: Manage all aspects of Investigative Sites to ensure patient safety and timely high quality data in compliance with regulations.

Responsibilities will include, but are not limited to, the following:

1. Investigative Site Monitoring - Demonstrate a commitment to quality in all aspects of monitoring, adhere to study monitoring plans, conduct Pre-study Visits at Investigative Sites, conduct Study Initiation Visits at Investigative Sites, conduct Interim Monitoring Visits at Investigative Sites, review investigator study file and reconcile versus trial master file, perform investigational product accountability, conduct Close-out Visits at Investigative Sites
2. Data Integrity -Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of the subjects during their participation in a study, evaluate data query trends and interact with study team in order to improve data quality, ensure issues of data quality are escalated and resolved with study team and CQA
3. Subject Safety - Perform safety reviews/SAE reconciliations, monitor the informed consent process, ensure investigative sites’ adherence to GCP, ICH guidelines, and local regulations
4. Train and Assist Investigative Sites- Attend Investigator Meetings, train investigative site personnel in GCP and ensure sites are conducting Celgene clinical research according to the protocol, local regulatory requirements, and other appropriate regulations, serve as the liaison between Celgene and assigned sites; build relationships with site staff at assigned sites
5. Communication - Identify site issues, ensure proper escalation, if necessary, and ensure resolution, create trip reports, confirmation/follow-up correspondence and telephone contacts for assigned sites, respond to audit findings, adhere to proper lines of communication within Celgene, attend and participate in study team meetings, keep information in the CTMS current; maintain calendar
6. Development - Maintain up-to-date medical and clinical knowledge for assigned therapeutic areas, mentor/coach new CRAs, maintain annual training records
7. Corporate Goals- Identify/evaluate potential investigators for future Celgene studies, build effective and positive relationships with Principal Investigators, ensure timely submission and review of CRF data and query resolution according with timelines set forth in the SMP, schedule travel following Celgene’s travel policy and submit expense reports in an accurate and timely manner
8. Regulatory Documentation - Prepare ethics submissions and local regulatory documents at the country level, as needed, maintain local document files at a country level, as needed, review translations for ICD and other study documents, as needed, oversee to assure SOPs are followed in obtaining translations on necessary study documents
9. Monitoring Lead (As assigned)- Serve on study team as monitoring manager, review RFPs regarding monitoring specifications, develop study monitoring plan and subsequent revisions, review, track and acknowledge monitoring visit reports, manage and track monitoring site visits to ensure quality monitoring, ensure adequate monitoring resources, ensure monitors are trained properly in the study requirements, track and report critical issues to study team, participate in CRF and protocol review process, attend, participate and present at Investigator Meetings, perform field assessments of Celgene and CRO FMs, as required, develop study-specific tools for Investigative sites and Field Monitors, conduct FM meetings, oversee CRO monitoring, as required


Skills/Knowledge Required:

- Significant medical and scientific knowledge
- Knowledge of investigational products under study
- Ability to comprehend protocols and supportive information
- Knowledge of Clinical Development Process
- Knowledge of regulatory environment and guidelines (ICH, GCP and CFR)
- Excellent written and oral communication skills including presentations
- Excellent relationship-building skills
- Ability to work in a cross-functional team environment
- Ability to work independently
- Working knowledge of SOPs relevant to position
- Demonstrated problem-solving skills
- Ability to resolve routine issues effectively and independently
- Organizational and time management skills
- Knowledge of software (EDC, CTMS, MS Office, etc.)
- Ability to travel extensively within North America including overnight stays
- Ability to drive an automobile and have a valid driver’s license

Key (PDI) Competencies:

- Works Efficiently
- Prepares Written Communications
- Builds Relationships
- Fosters Teamwork
- Shows Work Commitment
- Uses Scientific/Technical/ Functional Expertise
- Commitment to Quality
- Acts with Integrity
- Demonstrates Adaptability
- Develops Oneself
- Uses Sound Judgment

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Atlanta-Senior-CRA%2C-Atlanta%2C-GA-or-Tampa%2C-FL-Job-GA-30301/1854733/185473318547332012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSAtlanta, GA, USProduction
Neuchatel, Switzerland

PREREQUISITES

Bachelors Science degree +5 years of experience in management of team in pharmaceutical industry

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

- In charge of the daily management of the packaging team ( planning communication, team organization , control, checking of the defined targets)
- Adapt and manage the packaging planning compared to the logistic requests, in order to ensure delivery on time.
- Ensure training conformity of packaging team for secondary and manual activities.
- Conduct investigations into packaging failures, develop and implement remediation plan.
- Ensure participation of health authorities audit (i.e. FDA, Swiss medic, EMEA...), and internal audit
- Control , and complete all pre-establish documentation to ensure traceability of operations carried out ( packaging batch record)
- Drafting of Standard Operating Procedure, and also working procedure linked to the area of responsibility.
- Conform to the directives and instructions defined in the pharmaceutical site quality system
- Support and Participate to any development project executed on the secondary packaging area.( ie new validation process , )
- Coordinate improvement or development process linked to secondary packaging area
- Apply risk management techniques and/or participate to risk assessment/analysis group linked to packaging process.

Skills/Knowledge Required:

- Bachelors Science degree
- 5 years of previous supervisory experience in pharmaceutical industry, ideally in packaging activities
- Strong working knowledge to ensure compliance with applicable regulations i.e cGMP, FDA. Fluent in French and English
- Organized and rigorous, able to provide leadership and coaching to the packaging team in order to maintain an environment of trust and personal accountable.
- Demonstrated ability to effectively communicate with his team but also at all levels of the organizations
- Autonomous and aptitude to work on the ground
- Quality and integrity oriented
- High level of computer literacy ( MS office, Exel, )]]>http://jobs.celgene.com/job/Neuchatel-Associate-Manager-Packaging-Job/1855381/185538118553812012-06-14Celgene CorporationProductionfull-timeUSDstarting0BSNeuchatel, SwitzerlandCommercial Operations
Neuchatel, Switzerland

PREREQUISITES

5 years experience in business planning, experience within the pharmaceutical industry

Master degree in Business with specialization in Finance

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

General:

- Support the Director Business Planning & Analysis in providing ongoing analyzes, recommendations and presentations President of EMEA
- Act as a bridge between non-commercial and commercial functions
- Provide analysis and business support during business review process
- Assist in the execution of the 18-month quarterly forecasts for EMEA commercial
- Assist in the execution of the Annual Long Range Plan

Director support:

- 1. Support the Director Business Planning & Analysis in preparing and presenting the EMEA weekly commercial update to the EMEA Commercial Management (rotating responsibility with leading the LE and LRP) by:
- Preparing quantitative and qualitative analysis of affiliate’s performances
- Digest affiliate information into Executive Management relevant information
- 2. Support EMEA Disease Team(s) through:
- Providing financial and business planning support in analyzing M&A, in-licensing new technology, co-promotion and co-marketing activities
- Provide decision-making support in developing and communicating assumptions in the execution of the Annual Long-Range Plan
- 3. Oversee the Daily Sales reporting process through:
- Partnering with IT and HQ Accounting to ensure reports and business rules are updated
- Partner with IT in the development of new reports and analysis
- 4. Provide Financial and Business Planning support to the VP of EMEA Medical Affaris through:
- Affairs functional management
- Financial and data analysis to support key decision making
- 5. Prepare forecast of Commercial supply used in Clinical Trials in conjunction with Director of Transaction Management & Distribution

Skills/Knowledge Required:

- > 5 years experience in business planning, experience within the pharmaceutical industry a plus
- Master degree in Business with specialization in Finance
- Outstanding analytical skills combined with excellent written, verbal and interpersonal skills
- Proficiency in English, proficiency in another European language a plus
- Proficiency with Microsoft Office with excellent Excel & PowerPoint skills
- Extensive acumen in problem solving, managing priorities and a commitment to quality
- Self-starter with high flexibility and proactivity
- High resistance to stress in a very fast-paced environment.
- Ability to switch between detail orientation and helicopter view

Please send your letter of application and CV by Friday 4th May 12.00 NOON.]]>http://jobs.celgene.com/job/Neuchatel-Manager-Business-Planning-&-Analysis-EMEA-Job/1859773/185977318597732012-06-14Celgene CorporationCommercial Operationsfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Associate Director, Manufacturing Operations
Job ID: 13076
Location: Basking Ridge, NJ -110
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Manufacturing Development API - 3259


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

10 -15 years relevant experience in a related field, including 4 years of leading role in chemical synthesis, biologics or API manufacturing, planning, and outsourcing in the pharmaceutical industry.

PhD degree in advanced science (chemical or biochemical engineering, biology or chemistry)

A PhD degree may be substituted for 5years of related experience.

This position is responsible for the procurement of custom synthesis of APIs for preclinical and clinical development of new pharmaceutical products and commercial products.

Responsibilities will include, but are not limited to, the following:

The primary role of the Associate Director of Active Pharmaceutical Development (API) Development will be to lead and coordinate internal and outsourced development of API manufacturing processes for Celgene pipeline products. This position will supervise and/or play a central role in the planning and execution of projects to advance the development of the Company’s product candidates. Products may be for Pre-Clinical, investigational use, clinical supplies, or commercial sale. The responsibilities include:

1. Define, develop and implement API processes and development strategies based on scientific, technical, regulatory, and market place needs.
2. Lead transfer of new technology from Process R&D to Manufacturing Facilities for commercial and development compounds. Develop project plans which define timing, resources and overall project costs.Responsible for production schedules based on clinical API requirements.
3. Evaluate, recommend and oversee contract manufacturing organizations capable of providing the technical services required. Ensures suitable quality, optimal economics, and adequate supply chain security for commercial and clinical products.
4. Direct, coordinate, and execute product, process optimization, and validation studies using Quality by Design principles. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
5. Act as the primary contact/representative to internal and external clients for dosage form development on specified projects. Responsible of API supplies to support safety, development and clinical studies for multiple projects.
6. Lead multifunctional technical development teams on specified projects. Lead the resolution of technical issues related to development and commercialized products. Confers with contract vendors and analyzes vendors' operations to determine factors that affect prices and determines lowest cost consistent with quality, reliability, and ability to meet required schedules.
7. Coordination of project activities with other internal functions such as Regulatory Affairs, Quality Assurance, Analytical R&D, Preclinical and Clinical functions, Sales/Marketing, etc.
8. Author, review and approve CMC related documentation as required for the market application. Interact with FDA/EMA regulatory authorities pre- and post-submission as required. Ensures all regulatory requirements are met in the Technical Operations and Contract Manufacturing Facilities
9. Collaborate with Process R&D and Pharmaceutical Product Development and AR&D with a primary focus on final drug product dosage form/delivery systems while providing input into requirements for drug substance, and analytical methods.
10. Assure timely delivery of adequate supplies of APIs and precursors to meet project needs and identify and qualify sources of starting materials, intermediates, and APIs
11. Establish suitable agreements covering confidentiality, supply terms & conditions, and quality agreements
12. Monitor and troubleshoot key manufacturing activities, approve batch records and site visits
timely communicate risks and delays to project teams.


Skills/Knowledge Required:

1. Broad based knowledge of API chemical and API development and manufacturing.

2. Solid experience in API development with demonstrated expertise in small molecule development.

3. Understanding of drug substance characterization and impact on drug product development.

4. Ability to evaluate, and share data across functions for evidence based decision making.

5. Proven ability in chemical synthesis development and process improvements.

6. Development and validation of manufacturing processes.

7. Lead, and participate in technology transfer activities.

8. Strong communications skills with a team oriented approach.

9. Project Management skills including the ability to prioritize, schedule and manage multiple projects and resources simultaneously. Sound organizational and time management skills.
10. Working knowledge of international GMP requirements and quality systems.

11. Working knowledge of current regulatory guidelines (EMA and FDA).

12. Able to develop solutions to moderately complex problems, which require the regular use of ingenuity and innovation.

13. PhD in Chemistry, Biochemistry, or Biochemical/Chemical Engineering. A PhD degree may be substituted for 5years of related experience.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

J2W:20120503
]]>http://jobs.celgene.com/job/Basking-Ridge-Associate-Director%2C-Manufacturing-Operations-Job-NJ-07920/1859775/185977518597752012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSBasking Ridge, NJ, USJob Title: Associate Director, Commercial Regulatory Affairs
Job ID: 13080
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Regulatory
Department: Regulatory Affairs - 3691


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

BS or MS in scientific discipline or equivalent; 5-9 years pharmaceutical industry with 3-5 years in regulatory. Advanced degree preferred.

Responsibilities will include, but are not limited to, the following:

- Manage regulatory aspects of Post-Marketing regulatory submissions and communications with Food and Drug Administration (FDA) and Division of Drug Marketing, Advertising and Communications (DDMAC).
- Develop regulatory, strategic, and compliance plans for maximizing the commercial aspects for the marketing of Celgene’s products. Manage timelines and resources to achieve stated goals.
- Advise the Corporation on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales & Marketing and other product-related teams and the Copy Review Committee (CRC). Foster and facilitate teamwork between GRA and these allied functions.
- Contribute to the development and implementation of Corporate and Department procedures and policies for regulation of marketed promotional materials and press releases.
- Provide leadership for and manage regulatory aspects of the copy review / approval process for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to DDMAC in a timely fashion.
- Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Celgene’s pharmaceutical products. Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape. Provide colleagues in GRA and allied functions with cutting edge guidance on requirements and changes.
- Foster collaborative, efficient, and effective working relations with FDA in order to further build the cordial working relationship between Celgene and FDA
- Work closely with the GRA rep on Project Teams to support A&P Activities.


Skills/Knowledge Required:

- BS or MS in scientific discipline or equivalent. Advertising and Promotional experience is a must.
- At least 5-9 years of pharmaceutical industry experience, including 3-5 years in regulatory affairs. Preference for at least 3 years experience in post-marketing regulatory affairs, specifically pharmaceutical promotional activity.
- Knowledge of Advertising and Promotional FDA regulations and experience with FDA communication and contact is necessary.
- Excellent interpersonal skills and written and oral communications skills.
- Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze, and solve problems with minimal supervisory input.
- Able to accommodate modest amount of domestic travel.
- Ability to manage multiple responsibilities with high degree of self-motivation.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Associate-Director%2C-Commercial-Regulatory-Affairs-Job-NJ-07922/1862935/186293518629352012-06-14Celgene CorporationRegulatoryfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Vice President, Patient Advocacy
Job ID: 13084
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Other
Department: Advocacy - 3621


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

- Advanced degree with minimum of 10 years work experience in patient advocacy, the pharmaceutical industry or life sciences.

As a member of the senior management team, this position is responsible for development and implementation of a comprehensive patient advocacy strategy across therapeutic areas and throughout the product lifecycle, from research and development to launch and patient access. Develops and sustains valued partnership relationships with organizations advocating on behalf of patients. Engages patient advocates in policy issues of joint interest to support patient access to care and innovation in treatment. Manages governance and administration of patient advocacy grants, patient education grants and support for patient assistance. As a member of the Corporate Affairs Leadership Team, collaborates with government relations, market access policy and communications colleagues to advance initiatives that support patient access and health care innovation. Develops and leads a community of practice in patient advocacy partnerships across the company and around the world that demonstrates Passion for the Patient.

Responsibilities will include, but are not limited to, the following:

- Implement a comprehensive patient advocacy strategy that supports organizational strategic objectives and ensures alignment across a matrix environment.
- Develop annual and ongoing engagement plans for work with patient advocacy partners across therapeutic areas and geographies. These plans will be informed by colleagues on disease teams and at the regional/country level. This position will ensure implementation is consistent and coordinated.
- Ensure relevant and high priority initiatives , expected outcomes, stakeholders and potential partners are clearly identified and that extensive consultation and collaboration with others throughout the organization, and most importantly with external advocacy partners, is emphasized.
- Work with key medical and marketing colleagues to develop the patient advocacy strategy and coordinate outreach to and relationships with patient advocacy groups and others to develop alliances that will advance organizational goals.
- Work to further patient advocacy goals, including establishing and maintaining partnerships with key patient advocacy and global health leaders across the world.
- Build patient advocacy capabilities across Celgene. Establish internal forum for best practices in patient advocacy relations. Develop and lead a Celgene patient advocacy community of practice that is patient centered and demonstrates Passion for the Patient.
- Enhance Celgene’s standing as a patient centric company and seek input and feedback via benchmarking within the patient advocacy community.
- Optimize patient advocacy structure to align with Celgene therapeutic areas and geographic organization.
- Responsible for staff management and overall operations of patient advocacy function.
- Develop metrics and implement scorecard to measure and monitor progress against objectives.
- Serve as the principal spokesperson for the patient advocacy function.
- Partner with the US/EU commercial organizations to develop patient advocacy plans that are consistent with overall patient advocacy strategy and aligned with local priorities. Support local execution of specific patient advocacy plans.


Skills/Knowledge Required:

- Minimum 10 years executive management experience in patient advocacy, with a biopharmaceutical company or in the life sciences field
- Product lifecycle management experience highly preferred
- Advanced knowledge and understanding of patient advocacy in the US and Europe
- Ability to create and lead successful cross-functional and multi-disciplinary teams
- Excellent analytical and organization skills.
- Demonstrated customer focus orientation & credibility with customers and partners
- Ability to effectively lead teams of peers
- Must be able to manage a diverse work group, motivate them and maximize productivity
- Excellent communication and presentation skills
- Possess strong business acumen and financial skills. P&L experience or budget experience
- Regular travel will be required.
- Work experience in an international environment (is a plus)

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Vice-President%2C-Patient-Advocacy-Job-NJ-07901/1866129/186612918661292012-06-14Celgene CorporationOtherfull-timeUSDstarting0BSSummit, NJ, USJob Title: Analyst, QC Chemistry - 2nd Shift
Job ID: 13085
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Quality Ops
Department: Quality Control - 1103


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a Bachelors degree in Chemistry or related science from an accredited college or university with a minimum of 0-4 years related experience in a regulated laboratory, preferably in a pharmaceutical laboratory environment.
- An equivalent combination of education, experience and training may substitute.

POSITION SUMMARY

The Analyst performs and documents testing to support routine analysis of utility, raw material, in-process, finished product and stability samples. The incumbent assures individual compliance with the DEA and FDA regulations, cGMP’s and applicable department programs, including training, documentation, standard operating procedures, and Abraxis policies and procedures. Performs shift work as assigned. Approximate shift hours - 1st Shift: 6:00 am – 2:30 pm; 2nd Shift: 2:00 pm – 10:30 pm; 3rd Shift 10:00 pm – 6:30 am. Daily work hours may occasionally extend to up to 12 hrs. on an as-needed basis.

ESSENTIAL FUNCTIONS

- Perform responsibilities in accordance with organization’s policies and procedures.
- Prepare standard and sample solutions as required by test methods.
- Operate general analytical instruments during testing, (i.e. HPLC, GC, UV-VIS and IR spectrophotometers)
- Perform wet chemistry tests (i.e. LOD, pH, and titration).
- Maintain appropriate documentation as required by laboratory SOPs.
- Comply with good housekeeping and safety practices.
- Perform other duties as assigned.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Analyst%2C-QC-Chemistry-2nd-Shift-Job-AZ-85001/1866130/186613018661302012-06-14Celgene CorporationQuality Opsfull-timeUSDstarting0BSPhoenix, AZ, USIT
Neuchatel, Switzerland

PREREQUISITES

A high school degree (ETS/HES, Bachelor) in Computer Science, Information Systems, Telecommunications or equivalent experience

10+ years of relevant experience

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

- Coordinate, plan and deliver IT Infrastructure in line with global team
- Manage delivery of Windows 2008 and Linux systems as part of global IT projects
- Participate in Disaster Recovery solution architecture and related activities
- Configure new physical and virtual servers while documenting the implementation
- Administer the company’s Windows 2003/2008 Systems and Active Directory Infrastructure
- Administer the SAN attached Blade and Stand-Alone server infrastructure
- Responding to problem tickets for issues reported by clients and provides customer second and third level IT Infrastructure support via telephone, e-mail, and other tools
- Writing formal postmortems for production problems and providing feedback to architecture and development teams
- Follow standard operating procedures while maintaining validated servers
- Assist with the installation of off-the-shelf applications and document the installation procedures
- Oversee the maintenance / monitoring of systems within the environment to ensure optimal performance, to determine system upgrade/replacement schedules, and to meet established Service Level Agreement (SLA) commitments
- Learn to operate system management and monitoring tools to identify and assist in resolving potential security, reliability, and capacity and performance issues
- Participate in evaluation of server hardware and software. Research solutions and formulate recommendations
- Provide timely status updates to IT management
- Administer MS Exchange 2007/2010 & BES (Blackberry Enterprise Service)

Skills/Knowledge Required:

- Thorough knowledge of Microsoft Windows 2003/2008 operating systems, Active Directory, Exchange and related technologies in a multi-domain environment
- IBM Blade server and System x administration experience strongly desired
- Hands-on experience with IBM storage environments (SAN,NAS)
- Working knowledge of Linux
- Knowledge of Project Management Principles
- Working knowledge of virtualization and VMware environments
- General understanding of Networking and Network Security
- Solid communication and Project Management skills
- Current Microsoft Certifications a plus
- Organizational "Fit" Considerations: The candidate must be flexible to take on different tasks at short notice and have the ability to function in cross-functional team setup that consists of different disciplines
- Understanding and experience in working in a multinational environment
- Ability to take ownership of an issue, problem, or project and see it through to completion
- Strong written, oral and interpersonal communication skills in English are needed]]>http://jobs.celgene.com/job/Neuchatel-Senior-IT-Systems-Specialist%2C-Delivery-Job/1867449/186744918674492012-06-14Celgene CorporationITfull-timeUSDstarting0BSNeuchatel, SwitzerlandIT
Neuchatel, Switzerland

PREREQUISITES

A high school degree (ETS/HES, Bachelor) in Computer Science, Information Systems, Telecommunications or equivalent experience

5+ years of relevant experience

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

- Manage Linux Servers in an enterprise environment
- Administration of Linux-Based server operating system
- Configure new physical and virtual servers while documenting the implementation
- Administer the company’s Windows 2003/2008 Systems and Active Directory Infrastructure
- Operational Management of datacenter infrastructure including SAN, Servers, Virtualization and other Infrastructure related systems
- Responding to problem tickets for issues reported by clients and provides customer second and third level IT Infrastructure support via telephone, e-mail, and other tools
- Writing formal postmortems for production problems and providing feedback to architecture and development teams
- Follow standard operating procedures while maintaining validated servers
- Assist with the installation of off-the-shelf applications and document the installation procedures
- Oversee the maintenance / monitoring of systems within the environment to ensure optimal performance, to determine system upgrade/replacement schedules, and to meet established Service Level Agreement (SLA) commitments
- Learn to operate system management and monitoring tools to identify and assist in resolving potential security, reliability, and capacity and performance issues
- Participate in evaluation of server hardware and software. Research solutions and formulate recommendations
- Provide timely status updates to IT management
- Administer MS Exchange 2007/2010 & BES (Blackberry Enterprise Service)

Skills/Knowledge Required:

- Strong working knowledge of Linux Operating system and VMWare virtualization technology
- Thorough knowledge of Microsoft Windows 2003/2008 operating systems, Active Directory, Exchange and related technologies in a multi-domain environment
- IBM Blade server and System x administration experience strongly desired
- Hands-on experience with IBM storage environments (SAN,NAS)
- General understanding of Networking and Network Security
- Solid communication and Project Management skills
- Organizational "Fit" Considerations: The candidate must be flexible to take on different tasks at short notice and have the ability to function in cross-functional team setup that consists of different disciplines
- Understanding of Avaya Telephony architecture
- Understanding and experience in working in a multinational environment
- Ability to take ownership of an issue, problem, or project and see it through to completion
- Strong written, oral and interpersonal communication skills in English are needed]]>http://jobs.celgene.com/job/Neuchatel-IT-Systems-Specialist%2C-Delivery-Job/1867450/186745018674502012-06-14Celgene CorporationITfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Attorney - Corporate Counsel
Job ID: 13088
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Legal
Department: Legal - 4104


About Celgene

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

- Completed JD and current admission to the New Jersey State Bar are required.
- Must have at least 6 years law experience as an attorney with a healthcare-related law firm, regulatory agency, or pharmaceutical company.
- Awareness of laws and regulations impacting pharmaceutical manufacturers, including Food, Drug, Medicare, and product liability laws, as well as relevant state laws and regulations required.


Summary

Responsibilities will include, but are not limited to, the following:

- Provide strategic legal support for a wide variety of company operations involving the FDA, CMS, and FTC. For example, responsibilities will include:
- Providing advice and risk analysis on pricing, price reporting, and CMS issues.
- Providing operational guidance for spend transparency consistent with “Sunshine” provisions of PPACA and implementing regulations.
- Advising various business units on regulatory issues, including product exclusivity and lifecycle management.
- Providing Legal support and guidance for the development of product registration and supplemental submissions. Review all product labeling and labeling supplements prior to submission.
- Provide advice and risk analysis on Healthcare Compliance issues, especially promotion and advertising compliance. Review and approve promotional material prior to use.
- Provide legal support for the review of internal governance documents (policies, SOPs, etc.) and external legal documents with policy and compliance implications.

Minimum
Skills/Knowledge Required:

- Completed JD and current admission to the New Jersey State Bar are required.
- At least five years of experience as an attorney in contract law and technology transfer is required, including experience representing biotechnology or pharmaceutical companies, either as outside counsel or as an in-house attorney.
- Experience drafting and reviewing written policies.
- The Candidate should be admitted to practice the New Jersey State Bar should have outstanding academic credentials.
- Excellent communication skills (both verbal and written).
- History of self-motivation, sound judgment and excellent interpersonal relations.
- The position requires intelligence, initiative, responsibility, creativity, motivation, flexibility, and the ability to work independently with minimal supervision.


Preferred Skills/Knowledge:

- Background in biological sciences preferred.


Equal Employment Opportunity

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Attorney-Corporate-Counsel-Job-NJ-07901/1867451/186745118674512012-06-14Celgene CorporationLegalfull-timeUSDstarting0BSSummit, NJ, USJob Title: Sr. Manager, Labeling Regulatory Affairs - Overland Park, KS or Berkeley Heights, NJ
Job ID: 13091
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Regulatory
Department: Regulatory Affairs - 3691


About Celgene

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

- Completed Bachelor’s degree in pharmacy or other scientific discipline with at least 4 years experience in the pharmaceutical industry required.
- Regulatory labeling experience or equivalent required.
- Completed advanced degree preferred.
- Position location can be either Berkeley Heights, NJ or Overland Park, KS.


Summary

Responsibilities will include, but are not limited to, the following:

- Partner with Global Regulatory Strategy Leads and CCDS Teams in the development and maintenance of Company Core Data Sheets for assigned products.
- Partner with Global Drug Safety in the development and maintenance of Development Core Safety Information (DCSI) for assigned products.
- Partner with Regional Regulatory Strategy Leads in the development and maintenance of US prescribing information.
- Participate in development of labeling strategy, including contingency strategy for negotiation with FDA.
- Work with cross-functional teams to ensure that desired label statements will be adequately supported by submission documents.
- Provide global and US regulatory labeling expertise to teams.
- Ensure that draft labeling complies with all applicable regulations and guidelines.
- Ensure compliance of labeling with Company Core Data Sheet; manage deviations.
- Research regulatory precedent for the labeling of related products.
- Train Regulatory Affairs staff and other functions on labeling regulations, guidances, and processes.
- Work in close cooperation and coordination with EU Labeling Senior Manager for optimal efficiency.
- Assist Senior Director with management of CCDS process for assigned products, including management of deviations.
- Assist Senior Director with management of DCSI process for assigned products.
- Track implementation of revisions to CCDS into country labeling.
- Interface with Affiliate Regulatory Affairs personnel to obtain information and documentation.
- Update CCDS records and databases.
- Conduct labeling audits.
- Assess impact of regulatory initiatives related to labeling; develop and implement systems to comply with these initiatives.

Minimum
Skills/Knowledge Required:

- Completed Bachelor’s degree in pharmacy or other scientific discipline with at least 4 years experience in the pharmaceutical industry required.
- Regulatory labeling experience or equivalent required.
- Thorough understanding of US labeling regulations and good understanding of the drug development process required.
- Must have familiarity with global labeling regulations.
- Excellent communication (oral, written) and presentation skills are necessary for interaction with cross-functional product labeling teams .
- Must have excellent editing skills, planning and organizational skills and strong interpersonal skills.
- Position location can either be Berkeley Heights, NJ or Overland Park, KS.


Preferred Skills/Knowledge:

- Completed advanced degree preferred.


Equal Employment Opportunity

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Sr_-Manager%2C-Labeling-Regulatory-Affairs-Job-NJ-07922/1867453/186745318674532012-06-14Celgene CorporationRegulatoryfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Senior Director/Executive Director of Operations, Inflammation and Immunology Clinical R&D
Job ID: 13090
Location: Warren Township, NJ - 33
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Inflammation - 3608


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

Minimum of Bachelor Degree; advanced degree preferred (e.g., MBA, MS, PhD, PharmD)

Minimum of 10 years progressive work experience in the pharmaceutical industry or equivalent with at least 5 years of management experience.

The Senior Director/ Executive Director of Operations, Inflammation and Immunology Clinical Research / Development and Medical Affairs will lead the organizational activities that support and optimize the functioning of the CR/D &MA Department and assist the VP, Head I&I CR/D and MA with the management of departmental operations. S/He will drive forward activities that are essential for achievement of the I&I Objectives and Goals.

Responsibilities will include, but are not limited to, the following:

- Lead development and realization of long-term, mid-term and short-term strategic and operational planning for the Clinical R/D and MA groups as well as ensuring effective execution of the day to day tasks.
- Work with VP of I & I CR/D and MA, and VPs of MA and Early Development to facilitate operational aspects of the group.
- Partner with finance, Human Resources, Research, Business Developnment, Translational Medicine, Commercial to plan, track, and manage overall CR/D and MA budget, portfolio, workforce planning, and reporting on behalf of the CR/D and MA groups.
- Lead work process improvement / redesign teams for Clinical R/D and MA.
- Organize departmental meetings; identify and implement procedures to maintain optimal communication of strategic, portfolio and project activities within the Clinical R/D and MA Departments and between relevant functions.
- Support creation and management of presentations for internal and external audiences
- Manage contracts with outside consultants and vendors.


Skills/Knowledge Required:

- Ability to anticipate changes and deficiencies and address them to minimize negative outcomes.
- Experience in aspects of the pharmaceutical industry needs.
- Highly proficient at developing budgets and forecasts and presenting these to management for approval.
- Experience managing across functions in a matrixed environment.
- Knowledge of GXP and ICH Guidelines.
- Experience presenting technical materials.
- Detail-oriented, well organized.
- Ability to assimilate technical, financial, strategic, operational, pharma-centric and commercial information quickly.
- Proficient in Microsoft Word, Excel, PowerPoint, Microsoft Project a plus.
- Demonstrated ability to work as part of a team.
- High level of interpersonal and communications skills, (written and verbal).

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Warren-Township-Senior-DirectorExecutive-Director-of-Operations%2C-Inflammation-and-Immunology-Clinica-Job-NJ/1867454/186745418674542012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSWarren Township, NJ, USJob Title: Associate Director Pricing and Market Access
Job ID: 13092
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Marketing
Department: Product Marketing - 2231


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

10 years experience in health care, with significant experience in Pricing, Reimbursement, Health Economics or Outcomes Research (7 years); Post-graduate training in health economics, outcomes research, strategic marketing or related fields; Experience with complex pharmaceutical treatments, in particularly oncology or immunology, and hand-on experience support product launches (ideally both US and ex-US markets)

The Assoc Dir. Global Pricing & Market Access, will support Celgene’s marketed products as well as future disease indications. He/she will be a key strategic marketing representative providing support to the appropriate indication teams as needed to ensure optimal clinical development strategies, adequate representation of outcomes research parameters, provide price forecasts & expectations, & proactively find ways to optimize lifecycle plans. The primary focus of the role will be Celgene’s mid and early stage pipeline opportunities, and he/she will be expected to provide advanced input on demand expectations, payer strategy, health outcomes differentiators, & general market access viability. At the same time, the individual is expected to support regional/local teams in their execution of launch & access strategies for in-line marketed products.

Responsibilities will include, but are not limited to, the following:

- Identification of payer needs (unmet medical need, suitable comparators and competitive space) and anticipation of their reaction to Celgene products.
- Conduct of a gap analysis between payer expectations and what the product can deliver.
- Development of a plan to address identified gaps through studies, publications, messaging and influencing.
- Protocol design for health economic studies and integration of payer relevant endpoints in the clinical development plan.
- Development of the product’s value proposition and steering the development/updating of the product value repositories (Health Economic model, value story, commercial toolkit).
- Identification of relevant and commercially attractive assets in the product pipeline in terms of a value proposition as well as the medical need compared to existing or upcoming therapeutic alternatives in the respective indications.
- Commissioning and preparation of health economic & outcomes research analyses necessary for reimbursement submissions & competitive messaging.
- Market research and provision of regular updates on the competitor landscape for Celgene’s individual product indications.
- Significant participation with advanced strategic contribution, in Celgene’s Global indication teams
- Participation as a key member of Celgene’s Global Marketing organization.

Skills/Knowledge/Experience Required:

- Has an in-depth understanding of payers and their perspective in the key worldwide markets, as well as trends in Pricing & Reimbursement.
- Has a solid scientific background enabling the assessment of trial design impact on payer strategies and the ability to challenge clinical development or medical affairs departments.
- Has an ability to interpret and critique clinical study protocols, as well as identifying relevant clinical endpoints and conducting outcomes research in the early phases of clinical trial development.
- Has a solid commercial background, gained through graduate training or prior experience
- Has an established and extensive network of payer contacts (pricing, reimbursement, policy, insurance) and KOLs.
- Has competitive intelligence, identifies early opportunities and threats in the market and creates solutions to benefit from opportunities and to disarm threats.
- Has ability to identify key product advantages in the context of market requirements and provides key ideas for developing individual value stories around Celgene’s products.
- Can develop a clear understanding of the company’s financial goals, with a clear ability to prioritize, setting up timelines on an international level.
- Can effectively liaise with Celgene Medical Affairs and Marketing teams, Celgene’s indication teams as well as Celgene’s local and regional teams, creating an efficient working style within a diverse organizational matrix.
- Possesses a commercial drive that leans toward strategic marketing, while at the same time is comfortable with technical or academic topics.
- Preferably has multi-year experience with health authorities, governmental economists and reimbursement agencies, hospital administrators and health care insurance companies’ general management, acquired at pharmaceutical companies, sickness funds, physician associations or health care consultancy companies.

Competencies Required:

- Ideally has 10+ years experience in the health care field, including significant experience in pricing, reimbursement, outcomes research or health economics, in the pharmaceutical areas of Oncology, Immunology or other innovative and complex treatments.
- Has graduate level (Master or higher) training in economics or an analytical commercial discipline.
- Displays excellent business English skills, with first-rate communication abilities.
- As a representative of a function, good social / economic skills and a representative appearance is absolutely essential.
- Has strong influencing/negotiation skills and the ability to work at peer-level with experienced technical and commercial experts in other departments
- Displays business confidence to constructively challenge marketing and clinical colleagues
- Has excellent written, verbal and interpersonal communication skills, with the ability to communicate complex or technical content in a convincing way to non-technical audiences.
- Is a flexible team member with a positive attitude and the ability to prioritize projects.
- Is experienced and adept at navigating international, multi-lingual, and cross-functional organizational matrices within a diverse and cross-cultural work environment

Performance measurement:

- Timeliness, accuracy, completeness and quality of work team milestones, accomplishment of financial company targets and execution of Global objectives.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Associate-Director-Pricing-and-Market-Access-Job-NJ-07901/1870461/187046118704612012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSSummit, NJ, USJob Title: Associate Director Pricing and Market Access
Job ID: 13093
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Marketing
Department: Product Marketing - 2231


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

10 years experience in health care, with significant experience in Pricing, Reimbursement, Health Economics or Outcomes Research (7 years); Post-graduate training in health economics, outcomes research, strategic marketing or related fields; Experience with complex pharmaceutical treatments, in particularly oncology or immunology, and hand-on experience support product launches (ideally both US and ex-US markets)

The Assoc Dir. Global Pricing & Market Access, will support Celgene’s marketed products as well as future disease indications. He/she will be a key strategic marketing representative providing support to the appropriate indication teams as needed to ensure optimal clinical development strategies, adequate representation of outcomes research parameters, provide price forecasts & expectations, & proactively find ways to optimize lifecycle plans. The primary focus of the role will be Celgene’s mid and early stage pipeline opportunities, and he/she will be expected to provide advanced input on demand expectations, payer strategy, health outcomes differentiators, & general market access viability. At the same time, the individual is expected to support regional/local teams in their execution of launch & access strategies for in-line marketed products.

Responsibilities will include, but are not limited to, the following:

- Identification of payer needs (unmet medical need, suitable comparators and competitive space) and anticipation of their reaction to Celgene products.
- Conduct of a gap analysis between payer expectations and what the product can deliver.
- Development of a plan to address identified gaps through studies, publications, messaging and influencing.
- Protocol design for health economic studies and integration of payer relevant endpoints in the clinical development plan.
- Development of the product’s value proposition and steering the development/updating of the product value repositories (Health Economic model, value story, commercial toolkit).
- Identification of relevant and commercially attractive assets in the product pipeline in terms of a value proposition as well as the medical need compared to existing or upcoming therapeutic alternatives in the respective indications.
- Commissioning and preparation of health economic & outcomes research analyses necessary for reimbursement submissions & competitive messaging.
- Market research and provision of regular updates on the competitor landscape for Celgene’s individual product indications.
- Significant participation with advanced strategic contribution, in Celgene’s Global indication teams
- Participation as a key member of Celgene’s Global Marketing organization.

Skills/Knowledge/Experience Required:

- Has an in-depth understanding of payers and their perspective in the key worldwide markets, as well as trends in Pricing & Reimbursement.
- Has a solid scientific background enabling the assessment of trial design impact on payer strategies and the ability to challenge clinical development or medical affairs departments.
- Has an ability to interpret and critique clinical study protocols, as well as identifying relevant clinical endpoints and conducting outcomes research in the early phases of clinical trial development.
- Has a solid commercial background, gained through graduate training or prior experience
- Has an established and extensive network of payer contacts (pricing, reimbursement, policy, insurance) and KOLs.
- Has competitive intelligence, identifies early opportunities and threats in the market and creates solutions to benefit from opportunities and to disarm threats.
- Has ability to identify key product advantages in the context of market requirements and provides key ideas for developing individual value stories around Celgene’s products.
- Can develop a clear understanding of the company’s financial goals, with a clear ability to prioritize, setting up timelines on an international level.
- Can effectively liaise with Celgene Medical Affairs and Marketing teams, Celgene’s indication teams as well as Celgene’s local and regional teams, creating an efficient working style within a diverse organizational matrix.
- Possesses a commercial drive that leans toward strategic marketing, while at the same time is comfortable with technical or academic topics.
- Preferably has multi-year experience with health authorities, governmental economists and reimbursement agencies, hospital administrators and health care insurance companies’ general management, acquired at pharmaceutical companies, sickness funds, physician associations or health care consultancy companies.

Competencies Required:

- Ideally has 10+ years experience in the health care field, including significant experience in pricing, reimbursement, outcomes research or health economics, in the pharmaceutical areas of Oncology, Immunology or other innovative and complex treatments.
- Has graduate level (Master or higher) training in economics or an analytical commercial discipline.
- Displays excellent business English skills, with first-rate communication abilities.
- As a representative of a function, good social / economic skills and a representative appearance is absolutely essential.
- Has strong influencing/negotiation skills and the ability to work at peer-level with experienced technical and commercial experts in other departments
- Displays business confidence to constructively challenge marketing and clinical colleagues
- Has excellent written, verbal and interpersonal communication skills, with the ability to communicate complex or technical content in a convincing way to non-technical audiences.
- Is a flexible team member with a positive attitude and the ability to prioritize projects.
- Is experienced and adept at navigating international, multi-lingual, and cross-functional organizational matrices within a diverse and cross-cultural work environment

Performance measurement:

- Timeliness, accuracy, completeness and quality of work team milestones, accomplishment of financial company targets and execution of Global objectives.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Associate-Director-Pricing-and-Market-Access-Job-NJ-07922/1870463/187046318704632012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Associate Director Pricing and Market Access
Job ID: 13094
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Marketing
Department: Product Marketing - 2231


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

10 years experience in health care, with significant experience in Pricing, Reimbursement, Health Economics or Outcomes Research (7 years); Post-graduate training in health economics, outcomes research, strategic marketing or related fields; Experience with complex pharmaceutical treatments, in particularly oncology or immunology, and hand-on experience support product launches (ideally both US and ex-US markets)

The Assoc Dir. Global Pricing & Market Access, will support Celgene’s marketed products as well as future disease indications. He/she will be a key strategic marketing representative providing support to the appropriate indication teams as needed to ensure optimal clinical development strategies, adequate representation of outcomes research parameters, provide price forecasts & expectations, & proactively find ways to optimize lifecycle plans. The primary focus of the role will be Celgene’s mid and early stage pipeline opportunities, and he/she will be expected to provide advanced input on demand expectations, payer strategy, health outcomes differentiators, & general market access viability. At the same time, the individual is expected to support regional/local teams in their execution of launch & access strategies for in-line marketed products.

Responsibilities will include, but are not limited to, the following:

- Identification of payer needs (unmet medical need, suitable comparators and competitive space) and anticipation of their reaction to Celgene products.
- Conduct of a gap analysis between payer expectations and what the product can deliver.
- Development of a plan to address identified gaps through studies, publications, messaging and influencing.
- Protocol design for health economic studies and integration of payer relevant endpoints in the clinical development plan.
- Development of the product’s value proposition and steering the development/updating of the product value repositories (Health Economic model, value story, commercial toolkit).
- Identification of relevant and commercially attractive assets in the product pipeline in terms of a value proposition as well as the medical need compared to existing or upcoming therapeutic alternatives in the respective indications.
- Commissioning and preparation of health economic & outcomes research analyses necessary for reimbursement submissions & competitive messaging.
- Market research and provision of regular updates on the competitor landscape for Celgene’s individual product indications.
- Significant participation with advanced strategic contribution, in Celgene’s Global indication teams
- Participation as a key member of Celgene’s Global Marketing organization.

Skills/Knowledge/Experience Required:

- Has an in-depth understanding of payers and their perspective in the key worldwide markets, as well as trends in Pricing & Reimbursement.
- Has a solid scientific background enabling the assessment of trial design impact on payer strategies and the ability to challenge clinical development or medical affairs departments.
- Has an ability to interpret and critique clinical study protocols, as well as identifying relevant clinical endpoints and conducting outcomes research in the early phases of clinical trial development.
- Has a solid commercial background, gained through graduate training or prior experience
- Has an established and extensive network of payer contacts (pricing, reimbursement, policy, insurance) and KOLs.
- Has competitive intelligence, identifies early opportunities and threats in the market and creates solutions to benefit from opportunities and to disarm threats.
- Has ability to identify key product advantages in the context of market requirements and provides key ideas for developing individual value stories around Celgene’s products.
- Can develop a clear understanding of the company’s financial goals, with a clear ability to prioritize, setting up timelines on an international level.
- Can effectively liaise with Celgene Medical Affairs and Marketing teams, Celgene’s indication teams as well as Celgene’s local and regional teams, creating an efficient working style within a diverse organizational matrix.
- Possesses a commercial drive that leans toward strategic marketing, while at the same time is comfortable with technical or academic topics.
- Preferably has multi-year experience with health authorities, governmental economists and reimbursement agencies, hospital administrators and health care insurance companies’ general management, acquired at pharmaceutical companies, sickness funds, physician associations or health care consultancy companies.

Competencies Required:

- Ideally has 10+ years experience in the health care field, including significant experience in pricing, reimbursement, outcomes research or health economics, in the pharmaceutical areas of Oncology, Immunology or other innovative and complex treatments.
- Has graduate level (Master or higher) training in economics or an analytical commercial discipline.
- Displays excellent business English skills, with first-rate communication abilities.
- As a representative of a function, good social / economic skills and a representative appearance is absolutely essential.
- Has strong influencing/negotiation skills and the ability to work at peer-level with experienced technical and commercial experts in other departments
- Displays business confidence to constructively challenge marketing and clinical colleagues
- Has excellent written, verbal and interpersonal communication skills, with the ability to communicate complex or technical content in a convincing way to non-technical audiences.
- Is a flexible team member with a positive attitude and the ability to prioritize projects.
- Is experienced and adept at navigating international, multi-lingual, and cross-functional organizational matrices within a diverse and cross-cultural work environment

Performance measurement:

- Timeliness, accuracy, completeness and quality of work team milestones, accomplishment of financial company targets and execution of Global objectives.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Associate-Director-Pricing-and-Market-Access-Job-NJ-07901/1870464/187046418704642012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSSummit, NJ, USJob Title: Project Manager II, IT PMO
Job ID: 13100
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: IT - Program Management Office - 4166


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

Demonstrated project management responsibility for global planning, directing and coordinating activities pertaining to ITIL and ITSM projects and activities. Bachelor’s degree or equivalent experience. PMP and ITIL certifications (such as ITIL V3) will be a plus.

Summary:

The successful candidate will ensure that objectives, goals and milestones are accomplished and in line with IT program objectives as outlined to develop and manage the overall project management plan, project schedule, scope and change management process, risk matrix, communications plan, and stakeholder engagement strategy.

Responsibilities will include, but are not limited to, the following:

- Report to project sponsors, project team leads, and other stakeholders on overall project delivery.
- Collaborate with the appropriate existing project team on all aspects of project delivery, including dependencies, schedules, issues, budgets, etc.
- Facilitate decision process, manage conflicts and resolve issues, escalating critical problems to Sponsors or key Stakeholders as necessary, ensuring major decisions are in harmony with goals.
- Facilitate and support business process redesign efforts across multiple business units as necessary.
- Build and maintain detailed project plans, including resource assignments, due dates, etc, in collaboration with program leadership team. Facilitate project team and status meetings as necessary.

Scope:

- Span of Control – enterprise-wide change management project for ITIL; delivery to Global IT GDS and IT GOS, others as required.
- Direct Reports – None
- Indirect Reports – None
- Budgetary Responsibility - Limited
- Interacts w/ - IT GOS, IT Directors, IT GOS, Business Executives and Directors, External Business Partners


Skills/Knowledge Required:

Strong knowledge of ITIL, including successful global implementation. In depth knowledge of relevant processes, technologies and capabilities is a must along with the ability to develop, plan and execute the program roadmap. Service-Now experience is required.

- Strong ITIL and ITSM background and knowledge and experience with proven success leading implementations and change initiatives. Ability to support related internal projects.
- Strong organizational, project management and analytical skills. Strong business acumen with the ability to plan and manage a global project budget.
- Expertise in setting and managing team expectations. Skill in conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management.
- Ability to communicate needs and schedules to clients, as well as ensure that plans are in place and standards are adhered to.
- Solid project management skills (includes MS Office and MS Project) with ability to multitask and manage multiple small to large projects in a cross-functional environment.
- Demonstrated abilities to lead and motivate staff, to apply skills and techniques to solve dynamic problems, to identify problem areas and opportunities and makes recommendations, to provide thought leadership, and to think strategically.
- Excellent oral and written communication skills, as well as ability to present and explain technical information in a way that establishes rapport, persuade others and gain understanding.
- Solid technical background to understand issues and obstacles in order to make accurate technical recommendations.
- Demonstrated capability in managing organization change management initiatives.
- PMP and ITIL certifications (such as ITIL V3) will be a plus.
- Minimum 8 years of experience.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Project-Manager-II%2C-IT-PMO-Job-NJ-07901/1875492/187549218754922012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSSummit, NJ, USJob Title: Senior Engineer, Project
Job ID: 13103
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Plant Engineering - 1113


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Bachelors degree in Engineering or related science from an accredited college or university with 5-7 years related experience in a pharmaceutical or engineering environment.
- Solid knowledge of facility and construction processes and project management.
- Familiarity with the Pharmaceutical Industry as related to cGMP, regulatory standards, quality systems and Biotech processes.
- An equivalent combination of education, experience and training may substitute.
- This position requires excellent problem solving and communications skills.
- Proficient in MS Office, MS Project, and AutoCAD.

POSITION SUMMARY

Responsibilities include the management of multidiscipline projects. Work includes management of engineers and/or architects as required by each assignment. Projects will range from the performing investigations and developing reports, to capital projects. The Senior Project Engineer is responsible for running cross-functional internal project teams of customer processes from initiation through project closeout and will be the primary internal and external contact regarding the day-to-day execution of the project.

ESSENTIAL FUNCTIONS

- Primary interface with the Customer for issues regarding the day to day running of the project
- Responsible for the internal running of customer projects. Accountable for project initiation, planning and for overseeing project execution, implementation, and closeout.
- Develop the project scope, define project guidelines, prepare project funding requests, obtain cross-functional sponsor approvals, and coordinate the resources necessary to successfully complete the project.
- Direct a multi-disciplinary project team to ensure delivery of the project on time, on budget and to the level of quality expected by the Customer.
- Expected to communicate major milestones both internally and externally.
- Identify potential project risks, provide continuing direction to the project team and conduct regular status meetings to review project activities.
- Responsible for prioritizing procedures for changing scope and project acceptance procedures.
- Responsible for the generation and issue of Project Team Meeting Minutes.
- Manage internal conflicting resource demands with the objective of keeping the project on track.
- Responsible for resolving internal project team issues and for coordinating decision making within the team.
- Organize internal pre meetings prior to customer interactions to ensure the suitability of presentations and to ensure everyone is in agreement with any results and conclusions.
- Nearing project completion, the Project Engineer is expected to obtain feedback to assure that project efforts meet the customers' expectations for agreed upon schedule, cost and objectives.
- Ensure the successful completion of owned projects and resolve any issues that may hinder project success. In addition, effectively lead the project team while maintaining good morale.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Senior-Engineer%2C-Project-Job-AZ-85001/1875493/187549318754932012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Operator, Aseptic - 2nd Shift
Job ID: 13102
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Manufacturing/Tech Ops
Department: Aseptic Operations - 1117


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- High School Degree required, BS degree preferred.
- Must have good understanding of cGMP requirements.
- Must have a proven technical understanding of processes system operations, equipment and problem solving.

POSITION SUMMARY

Responsible for the precise manufacturing of nab (nanotechnology albumin bound) and cytotoxic/antineoplastic products in accordance with batch record specifications. Ensures proper systems, equipment, materials, and other resources are in place to meet production demands through hands-on involvement and liaison with supervision. Ensures products are manufactured to specifications and in complete accordance with all cGMP, SOP, and Batch Records. Effectively manages resources to maintain production goals and efficiencies, assists with process improvements projects and programs. Performs area cleaning, equipment cleaning, and ensures proper operation and functionality of all equipment, hardware, tanks, and tools within the facility.

ESSENTIAL FUNCTIONS

- Ensures proper systems, equipment, materials, and other resources are in place to meet production demands.
- Manufactures products according to specifications and in complete accordance with all cGMP, SOPs, and Batch Records.
- Ensures area/facility cleanliness, equipment cleanliness, and proper operation and functionality of all equipment, hardware, tanks, and tools within the facility.
- Ensures all documentation is correct and addresses procedural /documentation errors expeditiously and effectively.
- Works closely with material and warehouse personnel to ensure batch materials and equipment are available to meet production timelines.
- Works with maintenance to minimize downtime, coordinate work scheduling, and ensure equipment is maintained in proper operating and validated conditions.
- Ensure proper operational supplies and consumables are on hand to meet production requirements.
- Complies with and enforces all hazardous material handling and safety requirements.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Operator%2C-Aseptic-2nd-Shift-Job-AZ-85001/1875494/187549418754942012-06-14Celgene CorporationManufacturing/Tech Opsfull-timeUSDstarting0BSPhoenix, AZ, USLegal
Neuchatel, Switzerland

PREREQUISITES

Strong administrative experience

Valid Swiss working permission or EU Citizenship required

Position summary

Under the supervision of the Manager Legal Contracts, the successful candidate will play a key role in supporting the efficient management of contracts as an integral member of the Contracts Team in the Legal Department. He/she will be responsible for coordinating the contracting activities and supporting the Contracts Specialist in the process of drafting and reviewing routine contracts (such as Confidentiality Agreements, Service Agreements and Consultancy Agreements). Must possess the ability to meet deadlines and to manage priorities, clients’ needs and expectations and be willing to work in an international environment where individual initiative and accountability to the team are required.

Responsibilities include, but are not limited to:

- Pre screening all contracts requests received by the Legal Contracts Team
- Dispatching all contract requests as appropriate to the Contracts Specialists
- Liaise with clients where required to request any additional information needed, clarify any areas omitted from the contract request form and ensure that all required information is available prior to dispatching to the Contracts Specialists
- Initiate the contract tracking process, ensuring all routing sheets are followed and other documentation are stored and archived as appropriate
- Under the guidance of the Contract Specialists, support the drafting of standard agreements and other basic templates
- Manage the signature process of certain contracts and archive them appropriately
- Provide general administrative support to the Legal Contracts Team
- Appropriately referring legal and process issues to manager and/or other lawyers in the Legal Department for review and direction.
- Ensuring compliance with policies and procedures, ethical practices, company values, and adherence to relevant laws and regulations.

Skills/Knowledge Required:

- Strong administrative experience, ideally gained within a Legal environment
- Excellent writing and editing abilities.
- Excellent planning & organizational skills and an ability to work with minimum supervision.
- Interpersonal skills to work as a team-player and to effectively work with people of diverse rank and culture across a variety of business disciplines
- Ability to quickly grasp business objectives, prioritize and organize work and handle multiple matters simultaneously.
- Ability to work under tight deadlines.
- Ability to identify, define and prioritize risks and communicate those to appropriate internal decision-makers for discussion and resolution.
- Experience working with a contract management and archiving system or other database document management system is desirable.
- A strong service orientation and positive “can-do” attitude.
- Fully committed to the job and to deliver in a timely manner outstanding work product.
- Accurate
- Logical and organized
- Flexible and receptive to change
- A natural and effective consultative style.
- Strong verbal and communication skills
- Proficiency in Microsoft Word, Excel and Power Point software programs.
- An interest in the life sciences field.
- Excellent English language skills required, additional languages are advantageous
- Experience in the pharmaceutical sector and exposure to healthcare compliance matters is a plus]]>http://jobs.celgene.com/job/Neuchatel-Legal-Coordinator-1-year-Maximum-Duration-Contract-Job/1877439/187743918774392012-06-14Celgene CorporationLegalfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Senior Manager, Accounts Payable / Accounts Receivable
Job ID: 13104
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Other
Department: Corporate Controller - 4130


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

Education: BA or BS in Accounting / Finance or equivalent work experience. MBA preferred.

Experience: 10+ years of Accounting / Finance experience with at least three direct managing the AP function. Minimum five years supervisory experience. Experience with a biotechnology and/or pharmaceutical company strongly preferred.

Responsibilities will include, but are not limited to, the following:

- Accountable for the overall success of the Accounts Payable (AP) and Accounts Receivable (AR) analysis, processes and related teams
- Direct management of AP manager, AR operations supervisor and AP customer service representatives
- Responsible for business process support in deploying key enabling technologies, including invoice imaging and workflow solutions for the AP area and the EDI functionality for the AR area
- Leverages AP system(s) and reporting to minimize administrative burden to the customer and streamline and automate auditing activities
- Establishes monitors, analyzes and reports on key performance metrics for AP and AR area. Adjust the steam and structure as needed in order to gain efficiencies and optimal processing for the AP and AR areas.
- Oversees functional management of AP including development and deployment of end-user training and ongoing customer support
- Responsible for AP and AR controls to ensure key risks are mitigated and team standard operating procedures are maintained and followed
- Project lead for significant AP and AR process improvements, compliance, and other ad hoc initiatives
- Collaborates with Corporate Compliance to ensure AP systems and processes comply with requirements for reporting of expense related to aggregate spend
- Oversees the total invoice to cash process, including receipts processing, and period end closing process for the Americas (all US and Canadian operations)
- Manages billings, collections, reconciliation, general ledger and month-end-closings with a main focus on accounts receivable functions.
- Develops AR policies and procedures and ensure compliance
- Leads identification of opportunities for continuous process improvement and innovate solutions and system enhancements so the team can operate in an efficient and cost effective manner
- Coordinates resolution of AR issues with key stakeholders including Order Management, Revenue Accounting, Contract Administration and Sales Operations


Skills/Knowledge Required:

- Excellent managerial skills and ability to create vision and strategy to drive team objectives and performance
- Strong interpersonal skills with all levels of management
- Excellent project management skills of small and large projects in cross-functional environment
- Expertise in AP and AR functional requirements.
- Able to understand and develop solutions for complex process / system driven problems
- Experience in a multi-site, multi-function shared services environment
- Strong understanding of end-to-end close to reporting cycle, ability to understand accounting flows related to AP and AR to ensure appropriate posting and reporting of expense in our financial reporting
- Ability to optimize business process through the strategic deployment and utilization of key technologies
- Robust understanding of financial systems, preferably direct experience with Oracle EBS and Concur. Direct experience with invoicing imaging and workflow type solution required.
- Demonstrated ability to manage and drive projects within a dynamic environment, maximizing the use of internal and external resources
- Outstanding oral, written and presentation skills; ability to influence management across multiple teams, and liaise with a large number of vendors
- Exceptional problem solving ability, balance of common sense and creativity
- Ability to juggle and prioritize multiple work streams

Behavioral Competencies:

- High degree of integrity with courage and commitment to do the right thing no matter what the situation
- Excellent negotiation and collaboration skills
- High sense of urgency and ability to identify creative solutions to time sensitive problems
- Strong customer service focus, with a drive to ensure that we exceed the expectations of our customers
- Outstanding oral, written and presentation skills; ability to influence management across multiple functions and geographies
- High degree of organizational agility, able to handle sensitive issues with prudent discretion across all levels of the organization
- Ability to implement best practices in back office operations; commitment to driving competitive advantage while managing costs, improving quality, and managing risks
- Commitment to delivering quality results and overcoming obstacles and challenges in a time-sensitive environment
- Good problem solving ability, balance of common sense and creativity
- Ability to juggle and prioritize multiple work streams, remains calm and effective under pressure

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Senior-Manager%2C-Accounts-Payable-Accounts-Receivable-Job-NJ-07922/1882452/188245218824522012-06-14Celgene CorporationOtherfull-timeUSDstarting0BSBerkeley Heights, NJ, USDrug Safety
Mississauga Ontario, Canada

• To manage safety data reported to Celgene Canada in accordance with corporate and regulatory requirements Responsibilities include, but are not limited to: 1. Management of Adverse Event (AE) case data through the receipt and triage of local AE reports received from Health Care Professionals or consumers. Reporting of such to Global Safety via the global safety database. 2. Initiation and conduct of follow-up activities related to local AE reports including direct telephone follow-up as required. 3. Assessment of local and global clinical trial and post marketed serious AE reports for submission to Health Canada in accordance with federal requirements. Provision of support to the Submissions Associate for all submission activities. 4. Support senior team members in training activities related to Drug Safety & AE reporting both internally and externally. 5. Assist senior team members in the management and maintenance of good customer relationships both internally with the Celgene Affiliate office and externally with key customers. 6. Assist in responding to safety inquiries received from Health Care Professionals or Health Canada. 7. Maintenance of high compliance standards with respect to reporting timeliness and quality of local AE data. Ensuring all standard operating documents are followed and that the department is inspection/audit ready at all times. 8. Champion Celgene Values. Skills/Knowledge Required: • BS degree, RN or Pharmacist qualification • Two years clinical experience • Good clinical knowledge of therapeutic area, patient populations and drug class • Excellent computer skills with full proficiency of MS-Office Applications • French language skills preferable • Knowledge of Health Canada requirements with respect top ADR Reporting and Pharmacovigilance activities. • Self-starter with superior time management skills, and ability to work independently or in teams • Very strong attention to detail.]]>http://jobs.celgene.com/job/Mississauga-Senior-Drug-Safety-Specialist-Job-ON/1884715/188471518847152012-06-14Celgene CorporationDrug Safetyfull-timeUSDstarting0BSMississauga Ontario, CanadaMedical Affairs
Neuchatel, Switzerland

PREREQUISITES

A business/administrative school graduate or equivalent in industry experience

Fluent in English and good knowledge of French

Valid Swiss working permission or EU Citizenship required

Competences :

- Responsible for administrative support for the Medical Affairs Department with a focus on meeting and travel arrangements and congress coordination. Strong organisational, prioritisation, interpersonal and communication skills are required.

Responsibilities include, but are not limited to:

- Provide administrative support to Medical Affairs team members as needed for day to day operations as well as individual projects as needed.
- Calendar and meeting organization, document formatting, arrange travel itinerary and related activities, congress coordination (follow up on deadlines for registrations, close cooperation with congress team members).
- Responsible for scheduling and organising various events and other meetings.
- Organize administrative systems to support department members including filing/records retention and other functions as required.
- Prepare documentation/materials for events upon needs.
- Telephone coverage as assigned.
- Other duties related to the above within Celgene as a whole, as assigned.
- Replacement of administrative colleagues in case of absence (Oracle, contracts and budget follow up, support for the Head of Medical Affairs, travel expenses, etc).

Skills/Knowledge Required:

- A business/administrative school graduate or equivalent in industry experience.
- Minimum 3 years administrative assistant experience.
- Must have strong interpersonal skills, be a team player and be willing to work in an environment where individual initiative and accountability to the team are required.
- Must be able to work with limited day to day supervision.
- Strong PC experience and Microsoft programmes experience.
- Excellent written and oral communication skills.
- Fluent in English and good knowledge of French.
- Must be able to appropriately handle confidential information.
- Ability to function productively in a fast paced and rapidly changing environment.]]>http://jobs.celgene.com/job/Neuchatel-Administrative-Assistant-Max-Duration-Contract-1-Year-Job/1884716/188471618847162012-06-14Celgene CorporationMedical Affairsfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Analyst II, IT
Job ID: 13109
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Information Technology
Department: IT - Program Management Office - 4166


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

Bachelor’s degree required. Minimum 7 years of relevant purchasing experience, accounting, experience strongly preferred, Associates degree with progressive relevant experience for a minimum of 7 years may be considered.

Summary:

The Analyst role functions as a PMO business specialist within the Information Technology Department. The role acts as a liaison between the Business functions (Procurement, Accounting Payable, Finance and Business Partners) and Information Technology. This position teams with IT partners and functional management and facilitates the relationships to deliver operational business capabilities through the coordination of business activities, collaborative planning, progress reporting, and the measurement of business results.


Responsibilities will include, but are not limited to the following:

- Assume liaison role with Business functions (Procurement, Accounting Payable, Finance, Legal, and Business Partners) and Information Technology. Primary liaison with A/P to help resolve payment processing issues.
- Analyze the implementation of new systems and procedures.
- Support PMO for assigned projects with budget maintenance reports and reviews.
- Preparation of Business Plans and forecasts for these functions.
- Prepare monthly Departmental Expense Analysis reports and provide business partners with explanations of key variances.
- Develop, Implement and manage assigned activities associated with the processing and execution of requisitions per department procedures for IT and all associated tracking.
- Managing the process of departmental invoices review and processing.
- Supports people/groups as needed with projects, analysis.
- Solve problems via troubleshooting the system and analyzing processes.
- Demonstrate Business/process knowledge and develop business acumen of core areas supported.
- Manage projects, including planning, organizing priorities, and providing status reporting.
- Identify gaps and implement process improvements to meet the dynamic needs of the business community.
- Act as liaison to Business by developing business requirements, supporting prioritization, proposing potential solutions.


Skills/Knowledge Required:

- Bachelor’s degree required.
- Minimum 7 years of relevant purchasing experience, accounting, experience strongly preferred, progressive relevant experience for a minimum of 7 years may be considered.
- Demonstrated experience with Oracle EBS, Livelink, Excel
- Project based business process experience preferred but not required.
- Regulated industries experience a plus.
- Exceptional verbal and written communication skills.
- Highly organized self-starter with an eye for detail who can maintain multiple ongoing projects simultaneously.
- Entrepreneurial, flexible attitude with ability to work well in ambiguous, changing situations and reprioritize work accordingly.
- Ability to effectively translate business requirements into system requirements required..
- Must be client-service driven with excellent analytical skills.
- Highly adaptable with hands on approach required.
- Must have strong interpersonal skills to work effectively in a team environment.
- Self motivated with independent functioning required
- Experience working on SDLC process is a plus

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Analyst-II%2C-IT-Job-NJ-07922/1887579/188757918875792012-06-14Celgene CorporationInformation Technologyfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Clinical Research Scientist
Job ID: 13108
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Hematology/Oncology - 3606


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Advanced Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), minimum 7 years experience in clinical research development or equivalent

Responsibilities will include, but are not limited to, the following:

1. Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
2. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.
3. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
4. Clinical study report preparation
5. Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
6. Participate in Development Planning for assigned compounds.
7. Oversee and challenge the adequacy of planning for study implementation
8. In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals
9. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects
10. Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety)
11. Collaborates and supports operational activities as needed
12. Assist in establishing project budgets
13. Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.
14. Participate and present at investigator meetings
15. Participate in adhoc meetings (e.g. marketing)
16. Assist in document template design and SOP writing
17. Participate on various corporate committees
18. Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required
19. Effectively manage conflicts/issues with internal/external partners and customers
20. Lead team meetings as required


Skills/Knowledge Required:

- Minimum 2 yrs. experience in medical or technical writing
- Clinical monitoring experience preferred
- Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.
- Extensive medical/scientific and clinical research knowledge
- Knowledge of Medical Terminology
- Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
- Proficient at data interpretation
- Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
- Experience in all aspects of the drug development process
- Knowledge of GCP and ICH Guidelines
- Experience in presenting at Investigator Meetings
- Detail-oriented, well-organized
- Limited travel required
- Ability to assimilate technical and scientific information quickly
- Clinical project management skills
- Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus
- Demonstrated ability to work as part of a team
- High level of interpersonal and communication skills (written and verbal)

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Clinical-Research-Scientist-Job-NJ-07901/1887580/188758018875802012-06-14Celgene CorporationClinicalfull-timeUSDstarting0BSSummit, NJ, USJob Title: Hematology Oncology Consultant, Hematology - Los Angeles & Hawaii
Job ID: 13110
Location: OffSite
Offsite Territory: Long Beach, CA
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Sales
Department: Salesforce - 2502


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Bachelor’s degree in Business or Science; minimum of 5 years’ sales experience in the pharmaceutical/biotechnology industry with two years Oncology experience preferred.

The Hematology Oncology Consultant is responsible for achieving all territory sales goals through the promotion, sale and support of company products or services in his/her geographic territory. This territory encompasses the "South Bay" area of LA, Western LA, and Hawaii (approximately 20% travel to Hawaii). The incumbent may live in either Los Angeles or Hawaii.

Responsibilities will include, but are not limited to, the following:

- Direct one-to-one communication with physicians and health care professionals in support of approved product indications.
- Providing customers with assistance in the best application of products: answers all questions concerning products, with appropriate referrals where required.
- Preparing and implementing a comprehensive business plan for territory.
- Contacting prospects and explaining features and benefits of products offered, utilizing persuasive sales techniques all within the boundaries of the Celgene Promotional Policy.
- Effective collaboration with a variety of internal cross functional partners to include clinical nurse consultants, patient support specialists, marketers, account managers, advocate development managers and clinical liaisons.
- Planning and organizing promotional speakers programs in territory in partnership with Speakers Bureau vendor and advocate development managers.
- Providing support to customers in the implementation of STEPS and Rev Assist programs.
- Communicating competitive market intelligence to brand teams and management.
- Timely and accurate completion of all administrative expectations.


Skills/Knowledge Required:

- BS in Business or Science; 5+ years sales experience in pharmaceutical/biotechnology industry with at least two years of oncology sales or specialty sales preferred or proven success in medical or business field.
- Prefer individuals with the desire/ability to relocate for roles of different scope or responsibility.
- Proven track record that demonstrates top sales accomplishments.
- Demonstrated ability to understand and communicate technical clinical material clearly and effectively.
- Ability to develop critical relationships with physicians, nurses and ancillary staff within academic hospitals, clinics, and private practice facilities.
- Demonstrated understanding of oncology therapeutic area, products and marketplace.
- Demonstrated knowledge of healthcare system processes including reimbursement.
- Possesses a strong work ethic, ability to develop priorities and manage time appropriately.
- Works with all members of a team effectively.
- Integrates innovative ideas in order to accomplish corporate and individual objectives.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Long-Beach-Hematology-Oncology-Consultant%2C-Hematology-Los-Angeles-&-Hawaii-Job-CA-90745/1887581/188758118875812012-06-14Celgene CorporationSalesfull-timeUSDstarting0BSLong Beach, CA, USJob Title: Hematology Oncology Consultant, Hematology - Queens
Job ID: 13111
Location: OffSite
Offsite Territory: Queens, NY
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Sales
Department: Salesforce - 2502


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Bachelor’s degree in Business or Science; minimum of 5 years’ sales experience in the pharmaceutical/biotechnology industry with two years Oncology experience preferred.

The Hematology Oncology Consultant is responsible for achieving all territory sales goals through the promotion, sale and support of company products or services in his/her geographic territory. This territory encompasses all of the Queens burrough and small portions of Manhattan and Brooklyn.

Responsibilities will include, but are not limited to, the following:

- Direct one-to-one communication with physicians and health care professionals in support of approved product indications.
- Providing customers with assistance in the best application of products: answers all questions concerning products, with appropriate referrals where required.
- Preparing and implementing a comprehensive business plan for territory.
- Contacting prospects and explaining features and benefits of products offered, utilizing persuasive sales techniques all within the boundaries of the Celgene Promotional Policy.
- Effective collaboration with a variety of internal cross functional partners to include clinical nurse consultants, patient support specialists, marketers, account managers, advocate development managers and clinical liaisons.
- Planning and organizing promotional speakers programs in territory in partnership with Speakers Bureau vendor and advocate development managers.
- Providing support to customers in the implementation of STEPS and Rev Assist programs.
- Communicating competitive market intelligence to brand teams and management.
- Timely and accurate completion of all administrative expectations.


Skills/Knowledge Required:

- BS in Business or Science; 5+ years sales experience in pharmaceutical/biotechnology industry with at least two years of oncology sales or specialty sales preferred or proven success in medical or business field.
- Prefer individuals with the desire/ability to relocate for roles of different scope or responsibility.
- Proven track record that demonstrates top sales accomplishments.
- Demonstrated ability to understand and communicate technical clinical material clearly and effectively.
- Ability to develop critical relationships with physicians, nurses and ancillary staff within academic hospitals, clinics, and private practice facilities.
- Demonstrated understanding of oncology therapeutic area, products and marketplace.
- Demonstrated knowledge of healthcare system processes including reimbursement.
- Possesses a strong work ethic, ability to develop priorities and manage time appropriately.
- Works with all members of a team effectively.
- Integrates innovative ideas in order to accomplish corporate and individual objectives.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Queens-Court-Hematology-Oncology-Consultant%2C-Hematology-Queens-Job-NY/1887582/188758218875822012-06-14Celgene CorporationSalesfull-timeUSDstarting0BSQueens, NY, USJob Title: Associate Director, IT
Job ID: 13112
Location: Berkeley Heights, NJ - 400
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Other
Department: ITGOS End User Informatics - 4174


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

- 7-10 years full-time managerial experience in a corporate and international environment managing a group of specialists in the area of IT process improvement
- Demonstrated leadership pertaining to ITIL and ITSM process planning, strategy, design, transition and operations activities
- Demonstrated leadership pertaining to process maturity assessments, skills capability mapping to roles, risk assessments, gap analysis and creating process implementation roadmaps.
- Employing COBIT, Capability Maturity Model Integration (CMMI) and/or e-Sourcing Capability Models to define, design, assess and improve ITSM processes
- Bachelor’s degree required
- ITIL advanced certification(s)

Summary:

The successful candidate will have a key leadership role in the area of process improvement in IT with a focus on ITIL/ITSM processes and tool implementation. The candidate must excel at working in a global, collaborative, diverse, complex, resource-constrained environment and be able to lead decision-making processes that involve multiple constituencies and constraints. He or she will be expected to continuously improve systems and processes that fall within the range of their responsibilities.

Responsibilities will include, but are not limited to, the following:

- Manage and oversee ITIL/ITSM process functions for the ITGOS organization.
- Provide ITIL/process architect leadership and training to personnel to enhance performance.
- Plans, develops and makes the necessary recommendations in association with the immediate reporting authority, to assist in ITIL process improvement initiatives.
- Participate in committees, meetings and make suggestions for continuously improving the quality of processes in order to satisfy demands
- Facilitate and support business process redesign efforts across multiple business units as necessary.
- Responsible for managing, coordinating, designing and executing various projects
- Ensure compliance of ITIL/process best practices, standards and procedures.


Skills/Knowledge Required:

- In depth knowledge of ITIL processes, technologies and capabilities
- Strong ITIL and ITSM background and knowledge and experience with proven success leading global implementations and change initiatives.
- Demonstrated leadership pertaining to process maturity assessments, skills capability mappingto roles, risk assessments, gap analysis and creating process implementation roadmaps
- Knowledge of COBIT, Capability Maturity Model Integration (CMMI) and/or e-Sourcing Capability Models used to define, design, asses and improve ITSM processes
- Expertise in setting and managing team expectations. Skill in conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management.
- Demonstrated abilities to lead and motivate staff, to apply skills and techniques to solve dynamic problems, to identify problem areas and opportunities and makes recommendations, to provide thought leadership, and to think strategically.
- Excellent oral and written communication skills, as well as ability to present and explain technical information in a way that establishes rapport, persuade others and gain understanding.
- Solid technical background to understand issues and obstacles in order to make accurate technical recommendations.
- Demonstrated capability in directing/managing organization change management initiatives.
- Advanced ITIL certification
- Minimum 7 - 10 years of managerial experience.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Associate-Director%2C-IT-Job-NJ-07922/1887583/188758318875832012-06-14Celgene CorporationOtherfull-timeUSDstarting0BSBerkeley Heights, NJ, USIT
Neuchatel, Switzerland

Responsibilities include, but are not limited to:

- Main point contact towards Quality and Compliance in EMEA&APAC
- Management and coordination of Sarbanes Oxley related activities, including internal assessment, controls and external audit
- Management and coordination of all EMEA&APAC CxP based audits/inspections liaising directly with business Functional leader
- Management compliance related activities for EMEA&APAC initiatives and internally developed systems supporting GxP-regulated operations
- Review of policies, guidelines, and procedures governing of GxP compliant computer systems
- Coordinate training of Celgene staff regarding electronic records management, and other Quality Assurance topics
- Provide collaborative support to Celgene computer system owners and Celgene IT stakeholders regarding IT Quality and Compliance overall
- Perform compliance assessments of computerized systems
- Represent the IT EMEA&APAC Organization in the Computer Validation Governance Committee and in other appropriate Celgene project teams
- Advise IT EMEA&APAC regarding IT Quality and Compliance while focusing on process improvement
- Potentially manager pool of resources (contractors or employees) in a matrix environment

Skills/Knowledge Required

- University degree in Computer Science, Chemistry, Life Sciences or Engineering
- 5-8 years experience in Information Technology
- Knowledge of computer network and system security principles
- Familiarity with 21 CFR 11, GxP, SOX and PIC/s (Swiss and European standards) requirements.
- Knowledge of ITIL practices a definite plus
- Experience creating and executing computer systems validation documents]]>http://jobs.celgene.com/job/Neuchatel-Manager%2C-EMEA&APAC-Quality-&-Compliance-Job/1887584/188758418875842012-06-14Celgene CorporationITfull-timeUSDstarting0BSNeuchatel, SwitzerlandAdministration
Neuchatel, Switzerland

Responsibilities include, but are not limited to, the following:

- Provide administrative support to the VP HR EMEA for day-to-day operations as well as individual projects as needed
- Provide general administrative support to the HR leadership and other members of the HR team as and when required
- Responsible for making travel arrangements and handling the expense process for the VP HR and other members of the HR team as and when required
- Assist with the management of the departmental budget
- Open, sort and distribute mail, fax documents, keep files, order office supplies and maintain supplies.
- Responsible for scheduling, organizing and recording all HR meetings
- Organize administrative systems to support department members including filing/records retention and other functions as required
- Assist with the benefits administration of the Swiss based population
- Responsible for projects as and when required
- Schedule conference room usage
- Prepare presentation materials
- Other duties related to the above within Celgene as a whole, as assigned

Skills/Knowledge Required

- Must have strong interpersonal skills, be a team player and be willing to work in an environment where individual initiative and accountability to the team are required
- Must be able to work with limited day-to-day supervision
- Strong administrative assistant experience
- Strong PC experience and Microsoft Word experience required.
- Strong PowerPoint skills desirable
- Excellent written and oral communication skills]]>http://jobs.celgene.com/job/Neuchatel-Human-Resources-Administrative-Assistant-Max-Duration-Contract-1-Year-Job/1887585/188758518875852012-06-14Celgene CorporationAdministrationfull-timeUSDstarting0BSNeuchatel, SwitzerlandJob Title: Engineer / Developer II, IT
Job ID: 13115
Location: Berkeley Heights, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Other
Department: ITGOS End User Informatics - 4174


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

- Bachelor's Degree in Information Technology or comparable experience..
- Minimum 4 years of experience administrating Microsoft Windows desktop and/or server operating systems in a large scale enterprise environment.
- Minimum two years’ experience with scripting tools including shell scripting, VBScript, WISE Package Studio, MSI.


Summary

Desktop Engineer will be responsible for desktop and mobile device hardware & image engineering for a global enterprise environment.

Responsibilities will include, but are not limited to, the following:

- Desktop Engineer will provide technical design and support for global images and system management infrastructure.
- Ensure current process such as patch deployment and software / image deployment are properly designed in addition to providing 3rd level support to resolver teams
- Provide technical assistance in the construction and maintenance of a corporate standard desktop, laptop and mobile image
- Oversee the maintenance of the corporate images as hardware changes occur ensuring no incompatibilities
- Provide technical assistance based on the research of current software and operating system service packs, patches, updates and fixes for desktops. Make recommendations based upon the severity, critical need and implications to the environment and supported applications
- Assist in the planning and implementation of remote software deployment to customer's desktop computers via Altiris and/or SCCM deployment services client management tools with minimal disruption to the customer
- Utilize scripting, batch files and Wyse studio to create software packages for unattended installation
- Investigate and propose new technologies and techniques for both hardware and software to improve customer efficiency, security and productivity
- Ensure all new and proposed software is tested with existing images & hardware prior to deployment
- Assist with design definitions and platform integration
- Provide technical assistance within global engineering including requirements, design, development, and testing
- Work with project managers on global projects with a focus on technical design, risk assessment, costs, timing and benefits
- Work with business subject matter experts and key stakeholders to successfully integrate their solutions and objectives
- Provide desktop management automation through scripting to provide consistent and predictable services
- Install, customize, maintain, test, and troubleshoot operating systems and other systems software
- Perform root cause analysis to quickly recover from service interruptions, and to prevent recurring problems
- Unified Communication/ collaboration deployment and solution management

Skills/Knowledge Required

- Bachelor's Degree in Information Technology or comparable experience..
- Minimum 4 years of experience administrating Microsoft Windows desktop and/or server operating systems in a large scale enterprise environment.
- Minimum two years’ experience with scripting tools must include shell scripting, VBScript,, WISE Package Studio, MSI, , required
- Must have experience in a Global environment.
- Knowledge of Altiris Client Management suite
- Expertise in Antivirus management
- Full device encryption solutions experience
- Must be able to act in an SME role as the lead role for various projects and initiatives.
- Excellent knowledge of Active Directory in relation to deployment methodologies required.
- Extensive desktop operating systems and application interoperability knowledge.
- Ability to create utilities and tools to assist help desk technicians and improve support.
- Must have the ability to design, deploy, and support Windows based desktops in a large enterprise.
- Must be capable of evaluating, maintaining, and documenting desktop application packages.
- Experience in Engineering and/or supporting Windows desktops in a pharmaceutical or financial services environment.
- Must have experience in certifying that applications conform to user requirements.
- Microsoft Windows 7 education and/or certifications preferred.
- Mobile Device Management experience with Mobile Iron, Air watch, Good for Enterprise
- Experience with application package creation and deployment.
- Must have excellent writing skills for documentation of test results and changes in development, maintenance, and application standards.
- Must have specialized technical expertise or business knowledge as a member of a project team in the evaluation and testing of desktop applications.
- Desired skills and knowledge of networking and supporting other operating systems.
- Strong judgment and the ability to work in a global team environment.
- Excellent communication, organizational and prioritizing skills a must, able to work effectively at all levels of the organization.
- Advanced problem solver. Sorts through complex issues and conducts comparative analysis of multiple solutions.
- Knowledge of networking standards, protocols, security, troubleshooting, and performance tuning.
- Knowledgeable about IT processes including software development life cycle

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Berkeley-Heights-Engineer-Developer-II%2C-IT-Job-NJ-07922/1891298/189129818912982012-06-14Celgene CorporationOtherfull-timeUSDstarting0BSBerkeley Heights, NJ, USJob Title: Supervisor, QC Chemistry - 3rd Shift
Job ID: 13117
Location: Phoenix, AZ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Quality Ops
Department: Quality Control - 1103


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

EDUCATION/EXPERIENCE REQUIREMENTS

- Requires a Bachelors degree in Chemistry or related science from an accredited college or university with a minimum of 5-8 years related experience in a regulated laboratory, preferably in a pharmaceutical laboratory environment.
- Requires solid knowledge of quality control systems, including FDA and DEA compliance standards, regulations, and guidelines.
- Requires excellent oral and written communication, organizational and teamwork skills.
- An equivalent combination of education, experience and training may substitute.

POSITION SUMMARY

The Supervisor, Chemistry supervises daily activities of the QC laboratory and supervises the laboratory chemists responsible for routine and non-routine analysis of utility, raw material, in process, final product, and stability samples. Performs shift work as assigned. Approximate shift hours - 1st Shift: 6:00 am – 2:30 pm; 2nd Shift: 2:00 pm – 10:30 pm; 3rd Shift 10:00 pm – 6:30 am. Daily work hours may occasionally extend to up to 12 hrs. on an as-needed basis.

ESSENTIAL FUNCTIONS

- Supervise the daily operations of the work group and schedule and assign tasks and projects.
- Ensure that the laboratory's activities are conducted in accordance with the company's policies, procedures, and cGMPs.
- Ensure that the site and department objectives are met.
- Ensure that all raw material and component samples, in process and finished products sample, stability samples are tested and documented according to departmental procedures and released in a timely manner.
- Perform secondary review and approval of laboratory test results and documentation; analyze and interpret data; recommend, review, and approve corrective actions.
- Develop, review, and revise SOPs and Methods, ensuring accuracy, completeness, and compliance with cGMPs and FDA regulations.
- Ensure that employees are properly trained, and provide training and coaching for group members.
- Ensure a safe and non-discriminatory working environment for employees.
- Participate in the hiring process, provide performance evaluations and support career development of direct reports.
- Ensure timely communication with department members and internal customers regarding activities of the QC chemistry group.
- Conduct investigations and complete follow up corrective actions in a timely manner.
- Perform other duties as required.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Phoenix-Supervisor%2C-QC-Chemistry-3rd-Shift-Job-AZ-85001/1891299/189129918912992012-06-14Celgene CorporationQuality Opsfull-timeUSDstarting0BSPhoenix, AZ, USJob Title: Principal Investigator
Job ID: 13118
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Research
Department: Translational Development - 3252


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisite: Ph.D. with up to 12 + years pharmaceutical/biotech experience


Summary

Employee will lead a group of PhD and non-PhD level scientists studying the translational medicine of rheumatological, dermatological, fibrotic, and other inflammatory and immunological diseases. Being experienced in the pre-clinical and clinical development of novel therapeutics, employee will use current translational approaches to address questions of drug mechanism of action and explore disease-relevant outcomes. In vivo studies are coordinated through a separate research facility, contract research laboratories, and academic collaborations. Will be responsible for representing the Translational Development department within product development teams; will direct the efforts of support staff in carrying out laboratory research. Responsible for experimental design, clinical trial planning for pharmacodynamic and pharmacogenetic endpoints, and interpretation of results. Will provide training to new staff and less experienced employees as necessary. Will act as scientific leader in areas of expertise, and will advocate for department goals at governance committee and other interdisciplinary venues. Will make scientific presentations both internally and externally when appropriate. Employee will assist in the writing of non-clinical pharmacology study reports, will submit invention disclosures to support the patent process, and will write and publish peer-reviewed articles when appropriate and concordant with company interests. Employee will exhibit leadership strengths, and depth of scientific understanding in inflammatory and autoimmune disease areas.

Specific Duties

1. Promote the application of the principles of translational medicine to facilitate and accelerate the development of therapeutics for inflammatory and immune-mediated diseases of unmet medical need.
2. Lead laboratory research strategy for testing lead compounds in relevant disease models in vitro and in vivo, to understand mechanism of action and optimize therapeutic usage strategies.
3. Put in place a Translational Development plan for specified compounds which includes pharmacodynamic and pharmacogenetic endpoints
4. Lead a cross-functional multidisciplinary effort to develop compounds for inflammatory and immunological diseases on Project Development Teams.
5. Supervise Scientists and Research Associates, under the direction of the Senior Principal Investigator.
6. Analyze, interpret, and report experimental results.
7. Establish and maintain working relationship with contract laboratories, academicians and consultants.
8. Responsible for the evaluation of subordinates and recommends promotions, merit increases and/or adjustments.
9. Ensure that the Translational Development Department maintains current awareness in area of expertise, enhances the scientific credibility of Celgene through contributions to the scientific literature (publications/presentations), through extramural activities and scientifically related interactions with academic authorities.
10. Assumes responsibility for writing non-clinical pharmacology study reports, invention disclosures, as well as portions of clinical study protocols, investigator brochures, and regulatory documents such as INDs and NDAs.

The position requires an individual with:

- An advance graduate degree in a field of science related to inflammatory and autoimmune disease (Ph.D.) with at least 12 years of laboratory research experience, and at least 4 years of translational medicine experience in the industrial setting.
- Excellent communication skills to effectively convey scientific concepts and data at the corporate level, with internal working groups/project teams and external academic and industrial organizations.
- Team player, mentoring ability, excellent supervisory skills.


Skills/Knowledge Required:

Organizational Judgement

The incumbent must have planning skills for scheduling activities and meeting project team deadlines. The position requires problem solving ability, people management ability and skills in resolving technical questions in a multi-disciplinary environment. The incumbent must keep abreast of current techniques within the field and the various scientific areas affecting dermatology, rheumatology, fibrosis, or respiratory disease.

Supervision

Direct & Indirect - Supervises internal research as required. Also consultants and external experts as appropriate.

Accountability

The position is responsible for planning and executing research plans in the defined area of investigation., and for applying the acquired knowledge to the clinical research setting. This position has responsibility for the quality, quantity, timeliness, and scientific acceptability of translational development activities that result in reports that are submitted to regulatory authorities worldwide to support the approval of Celgene investigational and new drug applications and for the investigations necessary for internal decision-making.

Contacts: Principal recurring contacts, including their frequency and purpose.

- Internal - Frequent contact with various levels of R&D as well as moderate contact with colleagues in other departments (drug discovery, clinical, regulatory, marketing, finance, business development) at Celgene is required.
- External - Significant contact with, external experts and contractors, CRO's and laboratories, universities and appropriate professional groups as necessary.

Working Environment

Domestic and international travel to company meetings and scientific conferences may be required.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Principal-Investigator-Job-NJ-07901/1891300/189130018913002012-06-14Celgene CorporationResearchfull-timeUSDstarting0BSSummit, NJ, USJob Title: Corporate Counsel, SEC
Job ID: 13119
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Legal
Department: Legal - 4104


About Celgene

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

- Completed J.D. and admission to at least one state bar required.
- At least 6 years of experience securities law with a law firm or pharmaceutical company required, inclusive of working experience in securities law, complex licensing transactions and mergers and acquisitions.
- Extensive experience required in SEC filings including Form 10-K, Form 10-Q, Form 8-K, Forms 3, 4 & 5 and Schedule 14A.
- Must have experience as an attorney handling various projects including M&A, equity investments, licensing matters, collaboration agreements and other contracts for a pharmaceutical company.


Summary

Celgene Corporation seeks a Corporate Counsel to join the contract/transactional/securities sub-group of its legal department. The position will be located at Celgene’s headquarters in Summit, New Jersey. This position provides candidates with an opportunity to conduct a variety of legal work for Celgene. Candidates must have significant experience in securities law, mergers and acquisitions, and contracts law. Candidates must also have a proven ability to develop and implement legal strategies that support business and financial objectives. Candidates should have outstanding academic credentials. The position requires intelligence, initiative, responsibility, creativity, motivation, flexibility, maturity, and the ability to work independently with minimal supervision.

Required Skills/Knowledge:

- Completed J.D. and admission to at least one state bar required.
- At least 6 years of experience securities law with a law firm or pharmaceutical company required, inclusive of working experience in securities law, complex licensing transactions and mergers and acquisitions.
- Extensive experience required in SEC filings including Form 10-K, Form 10-Q, Form 8-K, Forms 3, 4 & 5 and Schedule 14A.
- Must have experience as an attorney handling various projects including M&A, equity investments, licensing matters, collaboration agreements and other contracts for a pharmaceutical company.
- Must have the ability to prioritize and multi-task, processing multiple projects to satisfactory completion.
- Must have the ability to appropriately balance legal and business risks while complying with short turnaround cycles.
- Strong attention to detail required.
- Must have excellent communication skills, both verbal and written.
- History of self-motivation, sound judgment and excellent interpersonal relations required.


Preferred Skills/Knowledge:

- New Jerseyor New York State Bars are preferred. Completed Bachelor’s degree in science is preferred.
- SEC experience is highly desirable.


Equal Employment Opportunity

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Corporate-Counsel%2C-SEC-Job-NJ-07901/1892973/189297318929732012-06-14Celgene CorporationLegalfull-timeUSDstarting0BSSummit, NJ, USJob Title: Coordinator, Human Resources
Job ID: 13121
Location: Summit, NJ
Offsite Territory: Category:

Human Resources
Department: Global Human Resources - 4103


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Associate’s Degree or equivalent experience. Minimum 4-5 years experience in an administrative or technical capacity. Human Resources highly preferred

Under the supervision of the Senior Director, Global Compensation, this position will be a key member of the Global Compensation team, providing support and analysis in the areas of broad-based compensation, equity compensation and relocation & expatriate administration. This position will also have responsibilities in support of the HR Systems and Shared Services function.

General Responsibilities:

Global Compensation

- Run reports from PeopleSoft, Kenexa as needed or requested (headcount reports, merit and MIP reports during year-end processing
- Perform routine audit checks on equity data in E-Trade system and run daily, weekly and miscellaneous reports such as account reports and termination reports
- Coordinate trade clearances with organization and ensure smooth processing with external vendors.
- Ensure smooth benchmarking process through daily monitoring of Benchmark inbox.
- Create and edit job codes on behalf of the organization.
- Perform analysis on workforce analytics, market data, etc. as needed to support the team.
- Answer routine inquiries from employees regarding equity accounts (i.e. logging on, E-Trade contact information) escalate where necessary.

Global Mobility

- Draft initial expatriate documents, ensuring accuracy and appropriate approvals.
- Serve as primary interface with global mobility providers to initiate domestic and international relocations and ensure smooth processing of global mobility program.
- Proactively manage PO process, notify when funds are low and initiate addition of funds to blanket PO in Oracle.
- Process of relocation and expatriate invoices.
- Work with internal stakeholders in finance, human resources, expatriate and transferee population to ensure smooth operation of Cost management process to ensure timely submission of expenses and timely reimbursement.
- Maintain roster of expatriates and transferees on behalf of the organization, including key information, current status and other pertinent information.
- Work with employees in mobility programs to answer questions on behalf of the program.

HR Systems and Shared Services

- Update annual global holiday schedule.
- Provide back up support to data coordinators as needed.
- Act as back up for voluntary and involuntary termination processing to ensure consistency with related procedural requirements.

Administrative

- Key point person for all compensation-related invoices in Oracle: receive, review and process invoices.
- Act as key liaison between Comp group and Shared Services team in finance to identify and resolve invoice processing issues.


Skills/Knowledge Required:

- Demonstrated ability to manage confidential information with professionalism
- Strong Excel, Outlook, PowerPoint and Word skills
- PeopleSoft experience highly preferable
- Self-starter and willingness to work in a team oriented environment
- Must be able to work independently with limited day-to-day supervision
- Strong customer relations skills

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Coordinator%2C-Human-Resources-Job-NJ-07901/1892974/189297418929742012-06-14Celgene CorporationHuman Resourcesfull-timeUSDstarting0BSSummit, NJ, USJob Title: Sr. Director, Healthcare Compliance Audit
Job ID: 13122
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Audit & Compliance
Department: Compliance and Ethics Group - 4108


About Celgene

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

- Completed Bachelor’s degree from an accredited undergraduate institution required. Applicants with a completed Bachelor’s degree only will be considered based on their working experience as directly-related to the business needs of this position.
- Completed graduate degree in a field directly-related to the business needs of this position and/or an MBA preferred.
- Must have at least 5 years of forensic investigation or auditing experience relating to healthcare compliance (“HCC”) with a global life sciences company or at an accounting firm.
- Currently possessing at least one of the following Audit Certifications is required - Healthcare Compliance Certification; CIA; CPA; CFE. Currently possessing more than one of these certifications is considered a significant plus factor.
- Must have demonstrable knowledge and understanding of all applicable HCC Rules.
- Required skills are strong attention to detail, and excellent auditing and audit report writing.


Summary

This position will be responsible for developing, implementing, and performing audits of compliance with: U.S. federal and state laws and regulations related to the promotion, sale and marketing of Celgene’s products; similar healthcare compliance (“HCC”) requirements outside the United States; and Celgene’s policies relating to the foregoing (collectively “HCC Rules”).

The position will report directly to the Corporate Vice President and Chief Compliance Officer and will be located in Summit, New Jersey. Significant travel (25 percent) may be required. Applicants local to our business location preferred; no relocation offered.

Duties and Responsibilities:

- Establish and implement auditing processes to evaluate compliance with HCC Rules and ensure that the processes are executed on a regular schedule.
- Develop, implement and update written policies and procedures to audit compliance with HCC Rules.
- Identify potential areas of HCC risk and develop an HCC audit program designed to address those areas of risk.
- Implement an HCC audit tracking system.
- Remain informed of developments in applicable HCC Rules and enforcement trends.
- Communicate HCC audit results to senior management and the line of business or department under review and ensure follow-up on any areas that require corrective action.


Skills/Knowledge Required:

- Completed Bachelor’s degree from an accredited undergraduate institution required. Applicants with a completed Bachelor’s degree only will be considered based on their working experience as directly-related to the business needs of this position.
- Must have at least 5 years of forensic investigation or auditing experience relating to healthcare compliance (“HCC”) with a global life sciences company or at an accounting firm.
- Currently possessing at least one of the following Audit Certifications is required - Healthcare Compliance Certification; CIA; CPA; CFE.
- Must have demonstrable knowledge and understanding of all applicable HCC Rules.
- Required skills are strong attention to detail, and excellent auditing and audit report writing.

Preferred Skills/Experience:

- Completed graduate degree in a field directly-related to the business needs of this position and/or an MBA preferred.
- Currently possessing more than one of the following certifications - Healthcare Compliance, CIA, CPA, and CFE - is considered a significant plus factor.


Equal Employment Opportunity

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Sr_-Director%2C-Healthcare-Compliance-Audit-Job-NJ-07901/1892975/189297518929752012-06-14Celgene CorporationAudit & Compliancefull-timeUSDstarting0BSSummit, NJ, USJob Title: Regional Director, Regional Medical Liaison (Southeast)
Job ID: 13120
Location: OffSite
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Medical Affairs
Department: Clinical Sciences Research - 3652


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.


Prerequisites

- MD, DO, PharmD, MSN or PhD in a scientific discipline OR RN, BA/BS in a scientific discipline and 3 years Celgene RML experience
- 10 years of related experience which includes at least 4 years of industry experience with a minimum of 2 years working in a field-based medical capacity

Position Description

The Regional Medical Liaison (RML) is a member of a field-based team of scientists who function as an extension of the US Medical Affairs organization. RMLs are responsible for developing and enhancing professional relationships with medical thought leaders involved in various phases of product development. RMLs provide medical information through scientific exchange in a fair-balanced manner and provide clinical/scientific support for Celgene and the Medical Affairs department at the direction of Medical Affairs management.

This position will manage a regional RML team. Working with the national head of the RML organization, this position will provide strategic and operational support for executing the ongoing RML strategy and plan of action (POA). This position will involve oversight of key RML programs regionally and nationally as necessary. The strategic areas of focus include health-care decision maker education and research (investigator initiated trials; IITs and registration studies).

A position for Regional Director of the Southeast hematology team that may span from Texas, east to North Carolina and south through Florida is available.

Responsibilities will include:

- Manage and develop all RMLs within the region including hiring, field training, evaluation, motivation and disciplinary activities in alignment with Celgene corporate strategies and objectives. Provide strong leadership to motivate region to achieve excellent results and deliver per the POA.
- Ensure that all interactions and activities in the region comply with Celgene business guidances, policies, and SOPs, OIG, ACCME, FDA, and PharMA guidelines/policies
- Interpret and translate national strategies and POA into regional POA including the development and execution of a regional opinion leader development strategy and then guiding/assisting RMLs in developing and executing an opinion leader strategy in their individual territories. Opinion leader development includes apporpirately engaging opinion leaders in research, as speakers, as consultants and other activities.
- Guide and mentor RMLs in the intake of research ideas for IITs by providing regional interpretations of national boundry documents. Ensure that the guidance is aligned with strategy and up to date.
- Guide and assist the RMLs in the coordination of opinion leader interactions within and across the region and with internal stake holders as necessary
- Coordinate within in Medical Affairs to appropriately deploy RMLs in the region to respond to unsolicited questions while managing regional capacity.
- Clearly communicate the national, regional, and territory plans, objectives, and POA; define, clarify and manage the regional team priorities; actively support the regional team and their efforts by being their advocate and spokesperson; promote collaboration within the team, across work groups and with customers
- Collaborate within Medical Affairs to appropriately respond to unsolicited requests for pipeline or off-label information
- Represent the RML function on US Medical Affairs teams as necessary
- Develop and maintain productive and appropriate relationships with individuals in other Celgene regional positions from the commercial and Clinical Development organizations. Appropriately partner with the commercial field team to provide necessary and appropriate medical resources in the region and corresponding districts.


Skills/Knowledge Required:

- MD, DO, PharmD, MSN or PhD OR bachelors level scientific education and 3 years of Celgene RML experience
- Minimum 10 years related experience which includes at least 4 years of industry experience with a minimum of 2 years working in a field-based medical capacity
- Excellent communication, presentation and time management skills required; must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization.
- Able to inspire a team to excel by fostering a climate of energy, excitement and personal accountability
- Demonstrated leadership in ambiguous situations
- Current working knowledge of US legal, regulatory, and compliance regulations and guidelines
- Ability to partner with key internal stakeholders to understand Celgene’s key objectives, and to drive plans that achieve or exceed these.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Regional-Director%2C-Regional-Medical-Liaison-%28Southeast%29-Job/1892976/189297618929762012-06-14Celgene CorporationMedical Affairsfull-timeUSDstarting0BSJob Title: Associate Director, Medical Affairs Scientist
Job ID: 13125
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Medical Affairs
Department: Medical Affairs Leadership - 3609


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prequisites: RN/PharmD/PhD


Summary

The Scientific Lead, Solid Tumors will support Medical Affairs Global Disease Leadership in Heme/Solid Tumors. This function will assist the Global Medical Affairs Disease Lead-Heme/Solid Tumors to effectively lead and implement the Global Medical Affairs Disease Strategy. This function will be accountable for working closely with Disease Lead, Heme/Solid Tumors to deliver enhanced efficiencies and quality around tactical deliverables, decision making, as well as internal and external meetings with customers.

Responsibilities will include, but are not limited to, the following:

- Leadership responsibilities: strategic and tactical
- Assist GMADL/GDT co-chair with all GDT responsibilities
- Represent US MADL on GDT
- Represent Medical Affairs in cross functional teams/meetings, e.g. Project Teams, Clinical Subteams, Global Congress Steering Cmt,
- Collaborate with all Disease representatives in Medical Affairs on Disease strategy and tactics
- Support/lead Medical affairs cross-functional working groups
- Perform, as needed, research and analytics and provide recommendations to support quality medical decisions regarding clinical research, consultancy, and internal planning.
- Conduct research and provide directed analytics and valuable backgrounders, as well as provide recommendations to guide Medical Leadership IIT decisions.
- Represent company at professional meetings, congresses, and local symposia.

Deliverable responsibilities: Strategic & Tactical

- Assist with Global and US Disease Strategy and Plans
- Track priority Med Affairs tactics in Disease Plans
- Partner with Sci Comm on developing Disease publication strategy, gap analysis, key messages
- High quality scientific/clinical input and review of:
- Disease strategy/plans,
- Abstracts, posters, slides, manuscripts in disease area
- Educational materials in disease area including slides, webcasts, etc
- LOIs/ IIT protocols in disease area
- KOL Steering cmt meeting objectives, materials
- CTB, booth panels
- Med info letters
- CDPs, Commercial Brand plans, Integrated Disease Plans
- ORQs in disease area
- Scientific educational grant requests
- Patient advocacy grant requests
- Assist with scientific searches, data summaries, preparation for site visits/corporate visits/payor presentations

Actively engage/interact with key stakeholders including:

Internal:

- Med Aff partners in disease area
- Global Medical Affairs Leadership
- Marketing
- Market Access
- Clinical
- BioStats
- Translational
- Regulatory
- Project Leadership

External:

- PIs, KOLs
- Global steering Cmt
- Scientific Advisory Boards (Registries)
- Advocacy groups
- Coop groups


Skills/Knowledge Required:

- RN/PhD/PharmD preferred.
- Minimum 5 years pharma/biotech industry or related experience.
- Experience in Medical Affairs and/or Clinical Development preferred.
- Proficient in critical data review and interpretation
- Strong Leadership skills.
- Able to lead in matrix organization.
- Excellent written and oral communication skills.
- Travel required

Competencies Required

- Leadership, Technical / Professional Knowledge, Planning and Organizing, Building Positive Working Relationships, Decision Making, Negotiation, Communication, Initiating Action, Customer Focus, Follow up, and Ongoing Listening and Learning
- Data handling/analysis-clinical trials and publications

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Associate-Director%2C-Medical-Affairs-Scientist-Job-NJ-07901/1892977/189297718929772012-06-14Celgene CorporationMedical Affairsfull-timeUSDstarting0BSSummit, NJ, USJob Title: Product Manager, Channel Marketing (REMS)
Job ID: 13124
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Other
Department: Market Access - 2204


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BA/BS required; biologic science degree helpful, but not required

The Product Manager’s (PM) responsibility will be the fulfillment of marketing responsibilities for the Celgene Risk Evaluation and Mitigation Strategy (REMS) programs.

Responsibilities will include, but are not limited to, the following:

REMS:

- Marketing lead for REMS steering committees and REMS Copy Review and.
- Participate in Product Risk Management Committee
- RevAssist, STEPS and future program software ,online and integrated voice response design requirements, user acceptance testing, training and deploymentDevelop and secure approval for REMS marketing materials
- Lead the development and execution of REMS training for internal and external customers
- Manage REMS program market research initiatives with nurses, pharmacists and physicians
- Partner with Regulatory, Drug Safety, Customer Care, Legal and Medical on FDA document submissions
- Lead the development and deployment of personal and non-personal promotional efforts for all Celgene REMS programs
- Partner with Information Technology and Customer Care to troubleshoot internal and external REMS system issues


Skills/Knowledge Required:

- BA/BS required, MBA a plus; biological science degree helpful, but not required
- Minimum 3 years’ pharmaceutical industry and minimum of 1 year product management/marketing research experience.
- Strong understanding of REMS programs (STEPS / RevAssist)
- Sales experience in the pharmaceutical industry a plus
- Oncology market experience preferred
- Must be PC literate in Microsoft Office
- Functional understanding of internet operations and capabilities preferred
- Excellent written and oral communication skills required
- Demonstrate initiative, creativity, strategic capabilities, and ability to work effectively in complex, rapidly changing environments
- Strong project and process management skills, along with the ability to work on multiple tasks, and to effectively prioritize
- Proven team player with ability to navigate cross functionally

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Product-Manager%2C-Channel-Marketing-%28REMS%29-Job-NJ-07901/1892978/189297818929782012-06-14Celgene CorporationOtherfull-timeUSDstarting0BSSummit, NJ, USJob Title: Senior Manager, Global Market Insights
Job ID: 13123
Location: Summit, NJ
Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Marketing
Department: Marketing Excellence - 2241


Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

BS/BA required; MBA or advanced degree preferred. 5+ years MR and/or BI experience in the pharmaceutical/biotechnology industry required. Experience in a globally operating team preferred

The Senior Manager of Market Insights will be a “disease expert” responsible for Market Research and Business Intelligence for a given disease area / indication.He or she is responsible for global market research & business intelligence activities including primary & secondary market research and, collection of competitive intelligence to inform global commercial strategy.

Responsibilities will include, but are not limited to, the following:

- Integrating information from various resources in the organization into deep insights:
- Engaging with Global Disease Team (GDT) and Project Teams (GPT) to understand business needs, goals and key strategic questionsCollaborating with GDT to ensure translation of available data and information into insights that drive our disease and brand strategies.
- Collaborating with Regional Colleagues in MR, BI, and Regulatory Intelligence to share information and create quarterly review of the business, market, customers, etc
- Collaboration with other functions (ie: Knowledge Services, Medical Information, IR, PR, etc) to understand secondary information in order to integrate disparate data into valuable insights
- Working with Medical Affairs to appropriately collect intelligence and translate into insight at key congresses Delivers top quality output of the function by:
- In collaboration with GDT develop KIT’s and KIQ’s based on strategic questions that drive insight creation and deepen our understanding of the respective disease area and operating environment.
- Creating relevant, actionable Market Insights plans including MR and BI to support disease area / indication. Aligning plans with regional colleagues and regularly re-asses plans as required
- Ensure existing data is made available and fully leveraged to answer strategic questions
- Utilizing unique methodologies as appropriate
- Execute agreed market research and BI activities in a timely manner and manage interactions with chosen agencies.
- Conducting all work within budget assigned, making tradeoffs as necessary

Skills/Knowledge and Experience Required:

- Deep knowledge of market research and BI methodologies, techniques and tools
- Ability to collaborate with colleagues in various regions, roles, etc
- Experience in delivering concise, clear presentations to variety of internal colleagues
- Demonstrated initiative, creativity, strategic capabilities, and ability to work effectively in complex, rapidly changing environments
- Strong project management skills
- PC literate including Word, PowerPoint, Access software, and Excel skills
- Successful candidate should have at least 5+ years of market research/business intelligence experience, preferably 2+ years hematology/oncology experience

Ability to demonstrate Celgene Corporate Values through passion for the patient, courage to face our challenges and the unknown, trust in our words and our actions and excellence in delivering exceptional results

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
]]>http://jobs.celgene.com/job/Summit-Senior-Manager%2C-Global-Market-Insights-Job-NJ-07901/1892979/189297918929792012-06-14Celgene CorporationMarketingfull-timeUSDstarting0BSSummit, NJ, USTechnical Operations
Neuchatel, Switzerland

PREREQUISITES

CFC de laborantin ou expérience en industrie pharmaceutique ou microélectronique de 2 ans

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

- Réalisation des opérations de conditionnement en packaging secondaire.
- Alimentation en matières premières et ou articles de conditionnement des lignes.
- Contrôle de la conformité des matières premières et ou articles de conditionnement utilisés sur les lignes.
- Contrôle physique élémentaire des produits conditionnés.
- Transférer les produits fabriqués vers le stade suivant.
- Maitriser la conduite des lignes de packaging secondaire
- Maitriser et effectuer le nettoyage des équipements et petits matériels liés à ces différentes étapes
- Effectuer le vide de ligne après production.
- Se conformer aux directives et instructions définies dans le système qualité de notre site pharmaceutique.
- Assurer la réalisation des opérations de fabrication des lots industriels en environnement GMP et rendre compte au responsable du département.
- Contrôler, enregistrer et compléter les documents de travail pré-établis pour assurer un suivi des opérations réalisées (dossier de lots remplis selon les GMP)

Skills/Knowledge Required:

- Avoir une formation initiale de niveau CFC de laborantin, ou une expérience de 2 ans dans le domaine de l’industrie pharmaceutique ou microélectronique.
- Connaître l’environnement GMP et/ou l’environnement de travail en salle blanche.
- Avoir une parfaite maîtrise du français.
- Polyvalent, organisé et rigoureux, vous avez de grandes qualités relationnelles pour un travail d’équipe.
- Connaissances des outils informatiques (Word, Excel)]]>http://jobs.celgene.com/job/Neuchatel-Packaging-Operator-Job/1894567/189456718945672012-06-14Celgene CorporationTechnical Operationsfull-timeUSDstarting0BSNeuchatel, SwitzerlandQuality Assurance
Neuchatel, Switzerland

PREREQUISITES

BS in Engineering or Technical discipline. 5 years experience in pharmaceutical industry

3 years experience in QA/QC

Valid Swiss working permission or EU Citizenship required

Responsibilities include, but are not limited to:

The position holder is responsible and accountable for the tasks given below. The list of tasks is non exhaustive, according to business needs other tasks might be assigned to the position holder.

- Ownership and responsibility of the Change Control and IT Change Control process: ensure initiation and appropriate contents (wording) of the change requests, perform initial QA assessment, route change request for evaluation and approval to the respective functions, provide feedback to business partners and ensure action tracking, evidence collection and closing of change controls and IT change controls.
- Ensures appropriate elevation of change requests to the global change process and participate to the Global change control committee.
- Support the Qualification and Validation manager in maintaining qualified equipment and validated system in compliance with cGMP as well as with policies, guidelines and procedures.
- Handles investigation as well as deviations for validation activities.
- Support the CAS (Computer Automated System) Validation manager in computer validation projects for Commercial off the shelf system and internally developed systems supporting cGxP regulated operations.
- Participate in the qualification and validation project teams as QA representative.
- Review and approve as representative of QA calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures where applicable
- Schedule and prepare periodic field reviews of qualified and validated systems including IT systems in cooperation with the Qualification and Validation manager and ensure compilation of field review reports.
- Assure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
- Represents Celgene International Quality Operations in the Change Control project team for the implementation of the new Global Quality Management software and is responsible for the implementation of the Change Control Module for Celgene International and Celgene Logistics
- Acting as QA representative (SME) during authorities inspections

Skills/Knowledge Required:

- Minimum BS in Engineering or Technical discipline.
- 5 years experience in pharmaceutical industry whereof 3 years in QA/QC-related function.
- Knowledge of international GxP regulations, 21CFR11, and good documentation practices.
- Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems.
- Excellent investigational and QA problem solving skills.
- Knowledge of most common office software (Microsoft Office) especially in Excel.
- Good communication skills in French and in English]]>http://jobs.celgene.com/job/Neuchatel-Associate-Manager%2C-QA-Validation-Job/1894568/189456818945682012-06-14Celgene CorporationQuality Assurancefull-timeUSDstarting0BSNeuchatel, Switzerland