Senior Manager, Medical Writing

Position Summary

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.

Key Responsibilities

Medical Writing & Content Development

• Serve as primary author and/or lead writer for key clinical and regulatory documents, including:
• Clinical Study Protocols and Amendments
• Investigator’s Brochures (IBs)
• 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.

Cross-Functional Collaboration

• Work closely with Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Nonclinical, and Quality teams to:
• Drive document timelines
• 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.

Process, Quality & Infrastructure

• 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.

Leadership & Development (scope dependent on level)

• 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.

Required Qualifications

• 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, verbal, and organizational skills with strong attention to detail.
• Proficiency with document authoring tools (e.g., Microsoft Word, Office suite, SharePoint, Adobe).

Preferred Qualifications

• Experience supporting gene editing/therapy or biologics programs.
• Familiarity with rare disease clinical development.
• Experience contributing to submissions across multiple development stages.
• Comfort working in a hands-on, fast-moving biotech environment.