Senior Manager REMS Operations

Job Summary

Managing the operational oversight of U.S. FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs, the full-time Senior Manager REMS Operations will ensure compliance with regulatory requirements, drive governance, and foster collaboration with internal stakeholders and external vendors while working remotely.

Key responsibilities

• Manage day-to-day operations of REMS programs, ensuring compliance with regulatory and governance standards
• Provide strategic oversight of REMS initiatives, ensuring timely execution of program objectives
• Coordinate REMS governance and operational workstreams, including meeting facilitation and documentation

Required qualifications

• Minimum of 4-6 years of experience in the pharmaceutical industry
• Experience in REMS and vendor management preferred
• Minimum of 2 years of pharmaceutical Project and/or Program Management experience
• Bachelor's degree (or equivalent) in a relevant field required
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)