Demo

Senior Director Medical Writing

GQR
Santa Rosa, CA Full Time
POSTED ON 1/20/2025
AVAILABLE BEFORE 4/20/2025

Senior Director of Medical Writing – Remote

  • In office / 1x per month / San Franisico)

Our Client : A late-stage biopharmaceutical company leading advancements in fibrotic disease therapies.

About the Role :

Our client is seeking a Senior Director of Medical Writing to spearhead the development of regulatory and clinical documentation. This critical hire will lead the function, collaborate with cross-functional teams, and contribute to ongoing late-stage trials.

Responsibilities :

  • Build and lead the medical writing team, including developing templates, processes, and SOPs.
  • Author key documents such as NDA / MAA submissions, IBs, and CSRs.
  • Partner with teams on protocol development and regulatory interactions.
  • Mentor junior staff while taking a hands-on approach to deliverables.
  • Qualifications :

  • PhD or MD degree in a scientific discipline.
  • 15 years of regulatory / clinical writing experience with pharma or biotech industry.
  • 5 years of management experience.
  • Experience with global regulatory submissions and ICH / GCP guidelines.
  • Work Location :

    Remote with travel to San Francisco Bay Area for on-site presence when needed 1x a month.

    Base Compensation : $260 – $280k Bonus Equity

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