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
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