Senior Manager, Regulatory Writing

Role Summary

The Senior Manager, Regulatory Writing is responsible for authoring regulatory documents and leading the development of these documents in collaboration with cross-functional teams. All work must ensure scientific accuracy, alignment with study and submission objectives, and compliance with SOPs, ICH/GCP, regulatory guidelines, and company goals.

Responsibilities

• Write, review, and edit clinical and regulatory documents such as clinical study protocols, CSRs, IBs, clinical summaries, and other documents as required for complex submissions (IND/NDA/BLA/MAA). Provide support for health authority briefing documents and responses to questions/requests for information, as needed.
• If a lead writer for assigned programs, serve as the primary point of contact for submission and project teams while acting as the lead author for complex documents and supporting document timelines and content strategy. May oversee additional writing and QC work performed by vendors.
• For large, complex documents (e.g., CSRs), plan kickoff meetings, define overall timelines, and lead authoring and comment resolution from initial draft through final approval.
• Arrange and conduct comment resolution/review meetings with cross-functional teams and resolve document content issues independently or collaboratively as needed.
• Work with cross-functional stakeholder groups (Clinical Research, Biometrics, Drug Safety, Regulatory, Clinical Pharmacology, etc.) to set priorities for document preparation, collaborate on content, and ensure scientific accuracy and alignment.
• Represent Regulatory Writing on project teams and advise on fit-for-purpose content and format requirements for various documents.
• Develop and drive timelines, and communicate writing process and timelines to team members.
• Provide status/updates of Regulatory Writing deliverables to management.
• Share and implement Regulatory Writing best practices to ensure efficiency and consistency across product teams.
• May contribute content to safety documents (e.g., DSURs, RMPs).
• May serve as a subject matter expert on systems and process initiatives including document management system implementations and updates to document development practices.
• Comply with established company policies and procedures, and industry and regulatory guidelines.
• Other duties as assigned.

Qualifications

• BA/BS in one of the life sciences with a minimum of 8+ years of scientific or medical writing experience at a biotech/pharmaceutical company; or MA/MS/PhD with 5+ years of relevant regulatory/medical writing experience with a deep understanding of regulatory standards and data-driven documentation.
• Excellent communication skills both orally and in writing.
• Ability to work independently and in cross-functional team environments with minimal supervision.
• Demonstrated ability to lead development of large/complex regulatory and clinical documents including CSRs, module 2 summaries, and regulatory authority meeting briefing documents.
• Ability to engage and disseminate information among appropriate stakeholders for effective document preparation.
• Strong attention to detail with the ability to write/summarize science-and data-driven content into clear, concise, and complete documents.
• Skilled in verifying data integrity, identifying errors and inconsistencies across various document types, and addressing them effectively.
• Ability to work effectively in a fast-paced environment with multiple high-priority projects.
• Ability to oversee consultants/contractors and serve as a liaison for project purposes.
• Excellent Project management skills.
• Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP).