SoTalent · 2 hours ago
Senior REMS Project Manager
United States
Full-time
Remote
Mid, Senior Level
4+ years expSoTalent is seeking a Senior REMS Project Manager to provide strategic and operational support for FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs. The role involves leading and coordinating REMS documentation, submissions, and team activities to ensure compliance with regulatory requirements while supporting executive leadership.
Staffing & Recruiting
Responsibilities
Manage the execution and operational oversight of U.S. FDA REMS programs
Prepare, coordinate, and track REMS regulatory documentation, including submissions, agency responses, and follow-ups
Lead and facilitate internal team meetings, vendor discussions, and cross-functional alignment sessions
Develop and maintain REMS stakeholder materials and documentation repositories, ensuring version control
Support senior leadership with project updates, presentations, and status reports
Maintain adherence to timelines, compliance standards, and operational requirements across all REMS initiatives
Qualification
Required
4–6 years of pharmaceutical industry experience, including 2–3 years in REMS preferred
2+ years of project management experience in a pharmaceutical or life sciences environment
Strong skills in Microsoft Office, particularly PowerPoint for executive communication and presentations
Excellent written and verbal communication, organization, and attention to detail
Ability to work independently in a remote environment
Bachelor's degree in a relevant field required
Company
SoTalent
At SoTechTalent, we specialise in connecting forward-thinking tech companies with world-class talent.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase