Senior Director, Medical Writer

Summary

Join Generate:Biomedicines, a leading therapeutics company, as a Senior Director, Medical Writing. Lead the development of critical regulatory documents for a pipeline of biologic therapeutics, including clinical protocols, Investigator’s Brochures, and clinical study reports. Oversee external medical writing contractors to ensure high-quality deliverables. Partner with cross-functional teams (Clinical Development, Regulatory Affairs, etc.) to align scientific narratives. Interpret complex data and synthesize it into clear, concise narratives aligned with regulatory standards. Contribute to regulatory strategy discussions and high-stakes submissions. This role requires extensive experience in medical writing within the biotechnology or pharmaceutical industry and an advanced degree in life sciences.

Requirements

• Minimum 15 years of medical writing experience in the biotechnology or pharmaceutical industry
• Advanced degree in life sciences (PhD, PharmD, or MS) required
• Extensive experience with nonclinical writing, including contributions to nonclinical study reports and nonclinical publications
• Demonstrated excellence in authoring core clinical documents: protocols, IBs, CSRs, narratives, and clinical summaries
• Strong knowledge of ICH guidelines and regulatory requirements for global regulatory submissions
• Excellent writing, editing, and analytical skills with a proven ability to translate complex scientific data into well-structured, regulatory-compliant documents
• Ability to work independently, manage multiple projects, and meet tight deadlines in a fast-paced environment
• Experience managing medical writing components of BLA/MAA submissions and coordinating cross-functional inputs
• Familiarity with eCTD submission standards and document management platforms (e.g., Veeva Vault)
• Experience overseeing contractors or vendor-managed writing teams

Responsibilities

• Lead the development and authorship of high-impact regulatory and clinical documents including
• Clinical Study Protocols and Amendments
• Investigator’s Brochures (IBs)
• Clinical Study Reports (CSRs)
• Manuscript publications
• Briefing Documents for regulatory meetings (e.g., Type B, EOP2, BTD, ODD)
• Module 2 summaries (2.5, 2.7.1–2.7.4) and other CTD components
• Interpret complex nonclinical and clinical data and synthesize them into clear, concise narratives aligned with regulatory standards
• Serve as the lead medical writer on cross-functional teams, providing scientific and regulatory writing strategy throughout product development
• Ensure alignment with FDA, EMA, and ICH guidance documents, and oversee document QC, accuracy, and consistency
• Support inspection readiness by ensuring high-quality documentation and traceability of source content
• Develop and maintain document templates, style guides, and best practices
• Manage outsourced medical writing vendors and contractors, ensuring compliance with project timelines, content expectations, and submission standards
• Participate in regulatory strategy discussions, contributing to the authoring of high-stakes submissions and regulatory responses

Benefits

Location : Remote; travel required to Somerville, MA office as business dictates