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← Treeline Biosciences

Associate Director / Director - Medical Writing, Oncology

Treeline Biosciences
Location
Any Office
Posted
1 month ago
Department
Regulatory
Salary
$164,450 to $224,787
What they actually want (must-haves)
  • Bachelor's degree in life sciences
  • 8+ years of regulatory/medical writing experience, with a significant portion in oncology drug development
  • Direct, hands-on experience authoring clinical and regulatory oncology submissions and/or amendments
  • Experience supporting responses to health authority inquiries (FDA and/or ex-US agencies)
  • Strong knowledge of ICH guidelines (E3, E6, M4/CTD format)
  • Excellent scientific writing skills
Nice to have
  • Experience with additional oncology-specific regulatory pathways (e.g., accelerated approval, breakthrough therapy designation, orphan drug designation)
  • Experience authoring documents listed above
  • Familiarity with document management systems
  • Prior experience in a small or growing biotech
What the job really is

The Associate Director / Director of Medical Writing in Oncology is responsible for authoring and coordinating high-quality regulatory and clinical documents for oncology development programs. This role involves close collaboration with cross-functional teams to ensure documents are accurate, compliant, and submission-ready, while also managing timelines and quality control. The ideal candidate will have extensive experience in oncology medical writing and be comfortable working independently on complex documents.

Things to weigh
  • No specific benefits listed
  • Salary range provided but may vary based on experience and location
  • Role requires strong independence and ability to manage multiple documents under time pressure
Job score3.8/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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