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Assoc Director, Compliance Operations

Req #: 17001743
Location: Summit, NJ US
Job Category: Regulatory Affairs
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Manager
Travel: Yes, 25 % of the Time
Other Locations:US- NJ- Summit West

Description

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.

Summary:

  • This role will contribute to the operational functionality of the Global Compliance department. Primary activities include health authority inspection oversight (management, training, and commitment monitoring, the generation of compliance metrics and analytics, use and management of information platforms, GxP and Health Care Compliance Audit (HCC) support, compliance monitoring (emerging regulations, GxP, HCC, and Corporate Policies), project management, training, document management, and continuous improvement.

Core Responsibilities:

  • This role is the primary Compliance Operations contact for the Americas and has responsibility over those regions for inspection management and providing operational support.
  • This role will be responsible for building, leading and developing the Compliance Operations role within the Americas.
  • Inspection Management: This position will have direct and/or indirect involvement in health authority inspections globally. Including inspection training, strategic planning, onsite support (inspection host, back-room team, SME, etc.), remote support, report assessment, response review and approval.
  • Compliance Monitoring: This role will monitor commitments made to health authorities and commitments associated with Celgene policy implementation. This position will also monitor the regulatory environment for changes or updates to guidance, regulations, and laws/statutory instruments, perform quality reviews of GxP and HCC audit records, and perform routine monitoring of GxP & HCC compliance.
  • Metrics and Analytics: This position will manage and mine data to generate routine metric reports for the GxP and HCC reports on monthly, quarterly, annual and ad hoc basis as part of trend and comparative analysis program to monitor compliance landscape for changes to risk/benefit profiles and compliance expectations.  
  • Information Platform Management (QR): This position will be involved in day-to-day management of GC information platforms.
  • GxP and HCC Audit Support: This role will provide day-to-day support of the GxP & HCC audit functions as needed. This involves addressing inquiries, coordinating audit planning, monitoring audit progress against yearly audit plans.
  • Training: This position will be involved in the identification of training areas, generation of training materials and execution of training Celgene personnel in compliance areas.
  • This role will perform other compliance operational activities including but not limited to compliance based research, provide compliance guidance, participate in cross functional teams/projects, project management, and identifying areas for continuous improvement.

Competencies:

  • Team development and management.
  • Critical and analytical thinking.
  • Problem solving skills.
  • Highly organized and focused.
  • Highly developed emotional quotient.
  • Effectively balances priorities, achieves goals, is able to multitask and manage time to meet deadlines with quality work products.
  • Advanced subject matter expert in health care compliance or at least one area of GxP with regard to compliance, laws and regulations.
  • Ability to effectively interact with colleagues, health authorities and government officials.
  • Is comfortable operating as a sole contributor and or as part of a team in a lead or role based capacity.
  • Highly developed skills in negotiation and conflict management.
  • Demonstrates initiative, drive and ability to successful execute responsibilities.  
  • Balances diplomacy and respectfulness with assertiveness.
  • Ability to identify issues, assess impact, develop solutions and determine when and what to communicate to senior managers.
  • Considers and incorporate global perspectives and requirements.
  • Demonstrated adaptability, comfortable with ambiguity and adapts style and tactics based on the situation.
  • Highly effective skills in written and verbal communications. Must be comfortable presenting in public.
  • Is comfortable providing guidance and constructive feedback to colleagues, peers, across functions and to senior managers.
  • Willingness and ability to bring healthy skepticism to identify and investigate areas of potential risk regardless of the circumstances.
  • Promotes open communication and is able to build consensus. 
  • Ability to independently manage effective communications regarding difficult topics to management and affected business areas.
  • Planning and project management skill set.
  • Training and coaching skills.
  • Is comfortable leading a team even if they are not the highest ranking person on the team.

Travel: Position requires minimally 25% travel   domestically and internationally.

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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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