Senior Manager, Medical Writing

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well‑understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities.

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Prime Medicine is seeking a Senior Manager, Medical Writing to support the development of high‑quality clinical, regulatory, and scientific documents across our gene‑editing pipeline. This role will be both hands‑on and strategic, contributing directly to authorship while helping to build scalable medical writing processes in a rapidly growing organization.

Reporting to the Head of Medical Writing, this individual will partner closely with Clinical Development, Regulatory Affairs, Research, and other cross‑functional teams to ensure accurate, consistent, and timely documentation supporting global clinical trials and regulatory submissions.

This is an excellent opportunity for an experienced medical writer who thrives in a collaborative, fast‑paced biotech environment and wants to grow into increasing leadership responsibility.

• Serve as primary author and/or lead writer for key clinical and regulatory documents, including:
• Clinical Study Protocols and Amendments
• Clinical Study Reports (CSRs)
• IND/CTA submission documents and briefing packages
• Critically analyze and interpret nonclinical, clinical, and external literature data to develop clear scientific narratives, conclusions, and messaging.
• Ensure consistency of content, data interpretation, and scientific positioning across documents and programs.

• Work closely with Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Nonclinical, and Quality teams to:
• Resolve data and messaging questions
• Ensure regulatory and scientific alignment
• Lead and participate in cross‑functional document review meetings and support responses to health authority questions as needed.

• Support the development and maintenance of:
• Medical writing templates, style guides, and standards
• Document workflows, timelines, and best practices
• SOPs and quality control processes
  
  Perform or oversee document QC, ensuring accuracy, clarity, formatting consistency, and compliance with internal standards and regulatory expectations.
• Evaluate and incorporate new writing support tools, including AI tools, to streamline processes and improve writing quality.
• Contribute to inspection readiness and submission quality initiatives.
• May mentor junior writers, contractors, or co‑ops as the team grows.
• Provide guidance on best practices in medical writing, document planning, and scientific storytelling.

• Advanced degree or bachelor’s/master’s degree in life sciences, health sciences, or a related field.
• ~5+ years of medical writing experience in biotech/pharma OR ~7+ years of writing experience in biotech/pharma or other scientific or academic setting. Includes document ownership and cross‑functional leadership.
• Strong experience authoring clinical and regulatory documents (protocols, IBs, CSRs, IND/CTA content).
• Solid understanding of clinical development and regulatory frameworks (FDA, EMA, ICH).
• Excellent written,…