Senior Manager Medical Writing

Senior Manager, Medical Writing (Regulatory) Remote | East Coast

About the Company

A global pharmaceutical company with a strong late-stage pipeline and a well-established regulatory function. This team operates with a high degree of collaboration across global markets and treats medical writing as a core strategic discipline.

The Role

We are seeking a Senior Manager of Regulatory Medical Writing to support late-stage hematology programs. This is a hands-on role with real ownership leading key submission documents.

Responsibilities

• Author and lead critical regulatory documents including CSRs, protocols, briefing books, informed consent forms, and Module 2 clinical overviews and summaries
• Manage timelines, coordinate cross-functional input, and drive documents from kickoff through submission-ready final
• Partner with Clinical, Regulatory Affairs, and global stakeholders to ensure accuracy, consistency, and strategic alignment across submission packages

Qualifications

• 8+ years of regulatory medical writing experience in the pharmaceutical or biotechnology industry; pharma-side experience strongly preferred
• Demonstrated ownership of Module 2 documents (2.4, 2.5, 2.7) on NDA, BLA, or MAA submissions
• Oncology experience required; hematology background preferred

Compensation

• Base Salary: $160,000 - $180,000
• Annual Bonus
• Long-Term Incentive
• Benefits

Managed exclusively by EPM Scientific. Company details shared upon initial conversation.