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Senior Manager, REMS Operations

Senior manager to run FDA-mandated REMS programs for a large pharmaceutical manufacturing company in the United States.

About the role

A large pharmaceutical manufacturing company in the United States is hiring for this role. You will manage the day-to-day operations and strategic execution of U.S. FDA-mandated REMS programs. The role exists to keep each program compliant, well governed and on schedule.

What you'll do

  • Manage day-to-day operations of FDA-mandated REMS programs
  • Ensure regulatory compliance and effective program governance
  • Coordinate cross-functional teams and external vendors
  • Monitor program risks and performance, and deliver program objectives on time
  • Maintain inspection-ready records and drive continuous operational improvement

What you bring

  • Working knowledge of U.S. FDA REMS programs and the regulatory requirements behind them
  • Experience managing cross-functional teams and external vendors
  • Ability to track program risks and performance and act on what you find
  • Discipline in keeping records ready for inspection

Details

  • Location: United States
  • Type: Full-time

Apply below and a Traverse recruiter will be in touch.

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