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Associate Director, REMS Strategy and Policy

Req #: 1700645
Location: Summit, NJ US
Job Category: Customer Service/Customer Care
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
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.

The Associate Director of REMS Strategy and Policy is responsible for the delivery of REMS operation solutions, and supports the Director of REMS Strategy and Policy in; (1) executing internal and external U.S. REMS projects, (2) advancing the REMS modification strategy, (3) progressing publication activities, (4) liaising with internal and external stakeholders, and (5) producing REMS Assessment reports.

Prerequisites:

  • BS/BA required, advanced degree in healthcare science or MBA, a plus
  • Minimum 7 - 10 years’ previous experience in Pharmaceutical Industry or applicable environments (REMS Operations, Medical Communications, Regulatory, Safety/Pharmacovigilance, or REMS Service Vendors) preferred.

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

  • Define the REMS modification strategy to support all NDA and sNDA submissions
  • Maintain the REMS communication and publication strategy, and accountable for the execution of assigned items
  • Represent U.S. REMS at external conferences and meetings
  • Collaborate with Celgene’s Federal and State Policy teams on activities regarding REMS regulations and statutes
  • Establish and maintain relationships with internal cross-functional partners, external REMS experts, and REMS vendors
  • Responsible for the development of the REMS Assessment Reports, and responding to any follow-up questions
  • Perform data analyses as needed in support of REMS Assessment Reports and REMS operations
  • Champion activities to continuously improve reporting approach and delivery
  • Manage execution of REMS program development and REMS submission activities to support pipeline products requiring a REMS
  • Responsible for the execution of assigned U.S. REMS projects, which includes:
    • Manage relationships with internal and external stakeholders
    • Produce project plans and monitor progress to ensure project goals are achieved
    • Negotiate timeline and resource requirements
    • Define and monitor budgets
    • Manage scope change process
    • Create project status reports for different audiences
    • Lead status meetings to ensure transparency and engagement
    • Establish and cultivate the right environment to enable high-performing teams

Minimum Qualifications:

  • BS/BA required, advanced degree in healthcare science or MBA, a plus
  • Minimum 7 - 10 years’ previous experience in Pharmaceutical Industry or applicable environments (REMS Operations, Medical Communications, Regulatory, Safety/Pharmacovigilance, or REMS Service Vendors) preferred.
  • Project Management and Client Services skills and experience, highly desired and preferred
  • Risk Evaluation Mitigation Strategies (REMS) knowledge and experience, including REMS modification submissions, highly desired
  • Advanced skills in MS Word, Excel, and PowerPoint

Desired Competencies:

  • Ability to independently manage multiple projects
  • Proven leadership skills across cross-functional teams
  • Strong negotiation, conflict resolution, and problem solving skills
  • Excellent verbal and written communication skills
  • Experience delivering oral presentations at internal and external events
  • Acute attention to detail
  • Adaptive, resilient, and nimble character, yet firm and sturdy in conviction and ethics
  • Highly strategic, proactively recognizes problems, and foresees improvement opportunities using a solutions-driven attitude
  • Strong interpersonal, listening and team building skills
  • People management experience preferred

#LI-POST

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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