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.