REMS Strategy Lead - Risk Evaluation & FDA Submissions

Scorpion Therapeutics; Princeton (NJ); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Job summary

Scorpion Therapeutics seeks a Senior Manager of REMS Strategy and Submissions to lead strategic and operational REMS activities, coordinating with internal teams and external vendors to ensure FDA submission readiness.

You will develop plans, map timelines, manage resources, and drive timely REMS submissions, leveraging regulatory knowledge and market insights to support product programs.

Qualifications

• BS/BA required; advanced degree preferred.
• 5–7 years pharmaceutical industry experience in relevant areas (Risk Management, Medical Communications, Medical Affairs, Regulatory, Safety/Pharmacovigilance). REMS experience preferred.
• US regulatory knowledge and REMS experience preferred.

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.

Skills

Communication

Regulatory knowledge

Project management

Microsoft Office

Cross-functional leadership

Education

BS/BA in a related field

Advanced degree preferred

Job description

Scorpion Therapeutics seeks a Senior Manager of REMS Strategy and Submissions to lead strategic and operational REMS activities, coordinating with internal teams and external vendors to ensure FDA submission readiness.

You will develop plans, map timelines, manage resources, and drive timely REMS submissions, leveraging regulatory knowledge and market insights to support product programs.