EPM Scientific · 1 week ago
Senior Manager, Project Management - Risk Evaluation
United States
Full-time
Remote
Mid, Senior Level
4+ years expEPM Scientific is a global biopharmaceutical leader focused on developing innovative medicines for patients with serious diseases. They are seeking a Senior Manager, Project Management to lead and support FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs, ensuring compliance and operational excellence.
BiotechnologyRecruiting
Hiring Manager
Emma Gener
Responsibilities
Execute and manage U.S. FDA-mandated REMS programs through effective project management
Prepare and coordinate REMS regulatory documentation, ensuring timely submissions and responses to FDA requests
Lead internal and external REMS meetings, manage timelines, and follow up on deliverables
Oversee development and updates of REMS stakeholder materials
Maintain submission archives and documentation repositories
Support senior leadership with presentations and project updates
Qualification
Required
Bachelor's degree in a relevant field required
4-6 years in the pharmaceutical industry
Minimum 2 years in pharmaceutical project management
Strong proficiency in Microsoft Office Suite and PowerPoint design
Excellent communication, organizational skills, and attention to detail
Ability to work independently in a remote environment
Preferred
2-3 years of experience with REMS preferred
Company
EPM Scientific
EPM Scientific is proud to be a leading specialist recruitment agency for the life sciences industry.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
S
Sean P.
Senior Vice President Commercial - Field at EPM Scientific
Recent News
BioSpectrum Asia
2023-12-23
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