Senior Manager, Medical Writing

Primemedicine

Watertown, MA, United States
Base: $153,096 - $188,095 usd; bonus/equity: eligi...
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Clinical and regulatory document authorship
Gene editing pipeline support
Cross-functional team collaboration
** Prime Medicine is seeking a Senior Manager, Medical Writing to play a pivotal role in developing clinical, regulatory, and scientific documents that support their innovative gene-editing therapies. The ideal candidate will have substantial medical writing experience in biotech or pharma and possess strong leadership abilities in a collaborative environment. **

Job Summary

  • Serve as primary author and/or lead writer for key clinical and regulatory documents, including Clinical Study Protocols, Investigator’s Brochures, Clinical Study Reports, and IND/CTA submission documents.
  • 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.
  • Support the development and maintenance of medical writing templates, style guides, standards, document workflows, timelines, and best practices, and evaluate new writing support tools, including AI tools.

Matching Summary

Match Score: 75

** Prime Medicine is seeking a Senior Manager, Medical Writing to play a pivotal role in developing clinical, regulatory, and scientific documents that support their innovative gene-editing therapies. The ideal candidate will have substantial medical writing experience in biotech or pharma and possess strong leadership abilities in a collaborative environment. **

Salary

Base: $153,096 - $188,095 USD; Bonus/Equity: Eligible for annual short-term incentive award and annual long-term incentive award; Benefits: Comprehensive Total Rewards package including health, financial, and wellness benefits

Skills & Requirements

Must-have

  • Clinical and regulatory document authorship
  • Gene editing pipeline support
  • Cross-functional team collaboration
  • Process and quality improvement
  • AI tool evaluation for writing

Nice-to-have

  • Experience with gene editing therapies
  • Familiarity with rare disease development
  • Fast-paced biotech environment adaptability

Key Requirements

  • 5+ years medical writing experience in biotech/pharma OR 7+ years writing experience in biotech/pharma or scientific/academic setting
  • Strong experience authoring clinical and regulatory documents
  • Solid understanding of clinical development and regulatory frameworks (FDA, EMA, ICH)
  • Advanced degree or bachelor’s/master’s degree in life sciences, health sciences, or related field

Work Rights

Not specified

Tailored Resume

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