Senior Manager, Medical Writing

Prime Medicine•Watertown, MA

About The Position

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.

Requirements

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).

Nice To Haves

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.

Responsibilities

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.
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.
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.

Benefits

Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.
Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.

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