Senior Manager, Risk Evaluation and Mitigation Strategies (REMS) Strategy and Submissions
Bristol Myers Squibb
September 01, 2026
Remote friendly (Princeton, NJ)
United States
Corporate Functions
Position Summary
Senior Manager of REMS Strategy and Submissions. Reports to the Director and is responsible for strategic/operational aspects of REMS programs, including REMS submission readiness packages to the FDA for US REMS programs.
Responsibilities
- Support REMS submissions teams to keep projects in scope/budget and submit to the FDA on time.
- Build short/long-term plans, set milestone targets, and adhere to deadlines.
- Map submission timelines for each product to meet FDA due dates.
- Define project scope with internal stakeholders and ensure feasibility.
- Ensure resource availability/allocation based on REMS projections.
- Develop and track detailed project plans for FDA REMS submissions.
- Coordinate stakeholder relationships and meetings with generic manufacturers; manage vendor/partner relationships.
- Lead vendor meetings; update REMS documents with vendors per guidance.
- Draft FDA information request responses; review/edit REMS documents (e.g., Assessment Reports, Modifications).
- Participate in FDA meetings; attend required conferences/training.
- Distribute submission updates (generic manufacturers, cross-reference letters & LOA) and support onboarding/maintenance for generic manufacturers.
- Maintain Readiness Go-Live scheduling for Quality/PV, Call Center/Portal Demo, and IT readiness.
Qualifications & Required/Preferred Skills
- BS/BA required; advanced degree in healthcare science/public health/applicable fields preferred.
- 5–7 years pharmaceutical industry experience in relevant areas (Risk Management, Medical Communications, Medical Affairs, Regulatory, Safety/Pharmacovigilance); prior REMS experience preferred.
- Excellent written/verbal communication; strong client/internal communication.
- Strong organization, attention to detail, multitasking; Microsoft Office.
- US regulatory knowledge and REMS experience preferred.
Benefits
- U.S. exempt employees: Flexible Time Off (FTO) and 11 paid holidays.
Desired Competencies
- Lead cross-functional teams; manage multiple projects independently with accountability.
- Strong analytical/critical thinking, listening, interpersonal skills; proactive, solutions-driven; adaptable and ethical.
Senior Manager of REMS Strategy and Submissions. Reports to the Director and is responsible for strategic/operational aspects of REMS programs, including REMS submission readiness packages to the FDA for US REMS programs.
Responsibilities
- Support REMS submissions teams to keep projects in scope/budget and submit to the FDA on time.
- Build short/long-term plans, set milestone targets, and adhere to deadlines.
- Map submission timelines for each product to meet FDA due dates.
- Define project scope with internal stakeholders and ensure feasibility.
- Ensure resource availability/allocation based on REMS projections.
- Develop and track detailed project plans for FDA REMS submissions.
- Coordinate stakeholder relationships and meetings with generic manufacturers; manage vendor/partner relationships.
- Lead vendor meetings; update REMS documents with vendors per guidance.
- Draft FDA information request responses; review/edit REMS documents (e.g., Assessment Reports, Modifications).
- Participate in FDA meetings; attend required conferences/training.
- Distribute submission updates (generic manufacturers, cross-reference letters & LOA) and support onboarding/maintenance for generic manufacturers.
- Maintain Readiness Go-Live scheduling for Quality/PV, Call Center/Portal Demo, and IT readiness.
Qualifications & Required/Preferred Skills
- BS/BA required; advanced degree in healthcare science/public health/applicable fields preferred.
- 5–7 years pharmaceutical industry experience in relevant areas (Risk Management, Medical Communications, Medical Affairs, Regulatory, Safety/Pharmacovigilance); prior REMS experience preferred.
- Excellent written/verbal communication; strong client/internal communication.
- Strong organization, attention to detail, multitasking; Microsoft Office.
- US regulatory knowledge and REMS experience preferred.
Benefits
- U.S. exempt employees: Flexible Time Off (FTO) and 11 paid holidays.
Desired Competencies
- Lead cross-functional teams; manage multiple projects independently with accountability.
- Strong analytical/critical thinking, listening, interpersonal skills; proactive, solutions-driven; adaptable and ethical.