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Prime Medicine, Inc. · 1 day ago

Senior Manager, Medical Writing

Watertown, MA

Full-time

Onsite

Senior Level

$153K/yr - $188K/yr

5+ years exp

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Senior Manager, Medical Writing will support the development of high-quality clinical, regulatory, and scientific documents while collaborating with various teams to ensure accurate documentation for global clinical trials and regulatory submissions.

BiotechnologyGeneticsLife ScienceMedicalTherapeutics

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

Qualification

Medical writing experienceClinical regulatory documentsClinical development knowledgeDocument authoring toolsGene editing experienceAttention to detailOrganizational skillsVerbal communication

Required

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)