Associate Director Medical Writing

The Associate Director, Medical Writing will serve as primary author on a heavy slate of regulatory documents across the company's pipeline. This is a senior individual contributor role with a clear path into people leadership — the majority of the department's managers were promoted from within.

The successful candidate will own complex documents end-to-end, partner directly with Clinical Development, Biostatistics, Regulatory Affairs, and Clinical Pharmacology, and set the quality standard on submission-critical deliverables.

• Lead-author protocols, Investigator Brochures, and Clinical Study Reports across early and late-phase studies
• Author Module 2 summaries (2.5, 2.7) and supporting CTD content
• Develop briefing documents, responses to health authority questions, and regulatory correspondence
• Drive cross-document consistency on submission-critical content
• Partner with cross-functional teams to define document strategy at kickoff, not just execute templates
• Mentor junior writers and contribute to departmental standards and best practices

• PhD or Pharm
  
  D required in a life sciences, pharmacy, or related discipline
• 7+ years of regulatory medical writing experience in biotech or pharmaceutical industry
• Documented lead-author experience on CSRs and Module 2 summaries
• Working knowledge of ICH guidelines, eCTD structure, and current FDA and EMA regulatory expectations
• Demonstrated ability to lead document strategy in cross-functional settings with senior scientists and clinicians
• Strong editorial judgment with emphasis on clarity, accuracy, and scientific defensibility

• A team people stay on. Average tenure in the medical writing department exceeds six years.
• Real internal mobility. The department's people managers were promoted from within. Both management and senior IC paths are supported and respected.
• Substantive work. A robust regulatory slate with documents that directly impact submission timelines and business outcomes.
• Hands-on authorship. This is a writing seat, not a coordination seat.