Medical Writer Job at Trebla Talent, San Francisco, CA

  • Trebla Talent
  • San Francisco, CA

Job Description

Position

Senior Director, Medical Writing

Location

Bay Area preferred

Reports To

SVP, Regulatory, Quality, and Pharmacovigilance

About the Company

Publicly traded, late-stage clinical biotech developing novel therapies for inflammatory diseases affecting the body, brain, and eye.

Role Summary

We're seeking a seasoned medical writer to build the function from the ground up - establishing infrastructure, standards, and processes, while hands-on authoring key clinical and regulatory documents in support of its growing late-stage pipeline.

Key Responsibilities
  • Direct authoring of critical documents
  • Build a scalable writing infrastructure, as well as budget/resourcing
  • Oversee internal and external authors/vendors on writing deliverables
  • Ensure documents meet ICH/FDA/EMA compliance standards
What You'll Need
  • 10+ years of medical writing experience
  • Smaller-company experience is a plus!
  • Prior experience with quality, scientific/regulatory documents.
  • Late-stage experience is wanted NDA/BLA/MAA
  • Experience managing a team of direct reports
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