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Associate Director, Medical Operations System Owner

Req #: 1800615
Location: Summit, NJ US
Job Category: Medical
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Employee Status: Full time
Job Type: Regular
Job Level:
Other Locations:US- NJ- Summit West


Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.


BS, BA, or equivalent work experience

Minimum 7 years relevant experience required

Experience in Healthcare or Pharmaceutical setting required

Position Summary

Responsible for the overall management of Medical Affairs Integrated Platform (Pathfinder) systems that support Investigator Initiated Trials (IIT) Management, Medical Information Requests Management, Publications, Educational Grants, Medical Content and cross-platform reporting and analytics.  Assumes functional ownership and partners with Line of Business (LoB) and IT colleagues in managing systems from concept to production, including maintenance, upgrade, troubleshooting, test scripts/User Acceptance Testing (UAT), implementation of new versions, end-user training, generating and creating reports as required.  Responsible for global system(s) governance and works with business partners worldwide to ensure alignment of system capabilities with business processes.  Develops and maintains systems’ data models for robust analytics using reporting tools to derive key customer insights. Active participation in platform governance and streamlining activities across the Pathfinder Platform to ensure alignment and consistency in order to maximize worldwide user adoption.

Core Responsibilities:

Embraces business ownership, overall management and oversight of one or more Pathfinder Platform systems, as appropriate. Engages global, cross-functional stakeholders within and beyond Medical Affairs to ensure optimized processes, consistent performance, and quality related to information maintenance and reporting. Works across global and functional teams to gather information and to apply this to define the scope and strategic objectives for business aspects of assigned systems on the Pathfinder Platform. Leads the definition of business processes and development/refinement of “best practice” procedures to influence users’ proper usage of the Pathfinder Platform. Liaises between Medical Affairs stakeholders (Hem/Onc, I&I and Corporate Medical Affairs groups) and IT teams in order to elicit information/ideas, analyze gaps/recommendations document/communicate/validate business needs/requirements for changes to the business processes, policies, and/or Pathfinder Platform. Leads all aspects of assigned system(s) launch and enhancement updates globally, including but not limited to assessing the global, regional and local needs of users, as well as user acceptance testing, implementation and training. Provides technical expertise; monitors system for performance, conduct trend analysis and ensures effective resolution through triage, troubleshooting and appropriate escalation.  Recommends potential solutions to ensure efficient and effective use of resources. Oversees integrations and data feeds into and outside of assigned systems and/or across Pathfinder Platform to ensure all business needs are met through partnership with appropriate business contacts. Captures and delivers business requirements for system(s) to IT and ensures they are tested and implemented effectively. Partners with business to ensure requirements are met for reporting and analytics, including development and maintenance of system specifics tools and reports that assist in identifying signals and trends in Medical Affairs data to promote informed decision making. Assesses training needs, creates training material, and delivers technical training on assigned system(s) and the Pathfinder Platform in general.  May partner with business to deliver coordinated process and technical training. Informs Pathfinder Platform executive sponsors and leadership of new and existing projects including status updates, risk identification and mitigation, financial impacts, communication plans and any escalations as needed. Performs data quality checks across assigned systems and platform to ensure accuracy and reliability of the data and identify any emerging trends or issues that necessitates system updates or training improvements. Oversees data stewardship activities for assigned system(s) and works in conjunction with Information and Knowledge Utilization (iKU) and Master Data Management (MDM) teams to execute data quality improvement initiatives. Engages actively with end users to gain continual feedback on systems and any recommendations for improvement to ensure optimal use and execution of business process. Serves as a Subject Matter Expert (SME) within Medical Affairs for existing systems and potential new additions to the Pathfinder Platform. Ensures awareness of current Medical Affairs trends within the industry and establishes global best practices regarding system(s) enhancement, usage and training.  Creates and implements departmental Standard Operating Procedures (SOPs) regarding processes and procedures necessary to achieve organizational objectives and for complying with government regulations and company policy.  Evaluates adherence to policies/procedures and institutes corrective action when needed. Participates as a SME for assigned system(s) during any internal, external audits and/or regulatory agencies inspections as required.  Responsible for collaborating with LoB and IT teams to timely execute Corrective and Preventive Actions (CAPA) on any observations/findings for assigned system(s). Performs other responsibilities as requested by management. May perform other oversight activities such as maintenance of documents within the systems and monitoring and communiation of expiry of existing medical content. Attends external meetings and educational seminars to enhance technical 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 Strong analytical, problem-solving skills with highly customer-oriented application support required Demonstrates project management skills and leadership for new and existing system enhancements Must be able to contribute with solution-oriented analysis for existing system changes and new solutions implementation Strong written and verbal communication skills and works well across teams Familiar with IT processes for system implementation and maintenance Practical knowledge of data governance, quality and stewardship 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.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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