Medical Writer

49 minutes ago


Boston, Massachusetts, United States Navigator Medicines, Inc. Full time

Summary
Navigator Medicines is a clinical stage biotech company pioneering a portfolio of best-in-class treatments for inflammatory and autoimmune diseases, focusing on OX40L combination approaches. As the Medical Writer, you will support clinical development by authoring and coordinating high-quality clinical and regulatory documents. This is a hands-on role in a small biotech environment, working closely with Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations.

Key Responsibilities

  • Author and edit clinical and regulatory documents (protocols, IBs, CSRs, ICFs, SAPs, regulatory summaries)
  • Coordinate document timelines, reviews, and cross-functional input
  • Ensure compliance with ICH, GCP, FDA, EMA, and other regulatory standards
  • Support IND/CTA submissions, amendments, and inspection readiness
  • Maintain document quality, consistency, and version control

Qualifications

  • Bachelor's degree in life sciences or related field (advanced degree preferred)
  • 3–7+ years of medical writing experience in biotech, pharma, or CRO settings
  • Experience authoring clinical trial and regulatory documents
  • Strong understanding of clinical development and regulatory requirements
  • Excellent writing, organizational, and collaboration skills
  • Experience in early-stage or small biotech environments preferred

Why Join

  • High-impact role supporting clinical programs
  • Broad cross-functional exposure
  • Mission-driven, growing biotech environment

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