Senior Manager, Project Management - Risk Evaluation
A global biopharmaceutical leader focused on developing innovative medicines for patients with serious diseases is seeking a Senior Manager, Project Management. This organization has a diverse portfolio in neuroscience and oncology and a strong pipeline of cutting-edge therapies. In this role, you will lead and support FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs, ensuring compliance and operational excellence. Responsibilities include managing regulatory documentation and submissions, coordinating cross-functional and vendor meetings, overseeing stakeholder materials, and providing strategic updates to senior leadership.
Key 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.
Qualifications
- Bachelor's degree in a relevant field required.
- 4-6 years in the pharmaceutical industry.
- 2-3 years of experience with REMS preferred.
- 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.
Note: This role focuses on Regulatory Project Management regarding REMS programs rather than Regulatory submissions.
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