Senior Manager, REMS Strategy

Job Summary

Reporting to the Director of REMS Strategy and Submissions, the full-time Senior Manager, REMS Strategy will manage strategic and operational aspects of REMS programs, ensuring timely submissions to the FDA while collaborating with various internal and external stakeholders.

Key Responsibilities

• Support REMS submissions teams to ensure projects are within scope and budget, and submitted on time to the FDA
• Create short and long-term plans, setting targets for milestones and managing submission timelines for REMS programs
• Develop detailed project plans to monitor progress and manage relationships with stakeholders, including generic manufacturers and third-party vendors

Required Qualifications

• BS/BA required; advanced degree in healthcare science, public health, or related fields preferred
• 5-7 years of prior pharmaceutical industry experience in areas such as Risk Management, Medical Affairs, or Regulatory, with REMS experience preferred
• Strong working knowledge of US regulatory requirements and REMS processes
• Excellent client-facing and internal communication skills
• Proficiency in Microsoft Office applications