Medical Writing Director

New

Skills

Clinical Protocols Clinical Study Reports (CSRs) Document Editing eCTD Formatting FDA Regulations ICH Standards Investigator's Brochure (IB) Medical Writing People Management Regulatory Writing

As the Senior Director of Medical & Regulatory Writing, you will lead a dynamic team responsible for creating high-quality medical documents in compliance with industry standards. You will be a subject matter expert for clinical protocols, clinical study reports (CSRs), Investigator's Brochures, and briefing books, ensuring timely delivery while collaborating with cross-functional teams.

Key Responsibilities
  • Lead the Medical & Regulatory Writing team and strategy.
  • Act as a subject matter expert for clinical protocols, CSRs, Investigator's Brochure, and briefing books.
  • Represent medical writing in cross-functional team meetings.
  • Collaborate with teams to ensure high-quality document delivery on time.
  • Adhere to ICH/FDA standards and company SOPs.
  • Oversee vendors and develop templates, SOPs, and workflows.
Requirements & Qualifications
  • Bachelor’s, Master’s or PhD in a scientific field; advanced degree preferred.
  • Strong people management and delegation experience.
  • 12+ years of medical writing experience in pharma/biotech/CRO; oncology experience preferred.
  • Proficient in authoring CSRs, protocols, amendments, and Investigator's Brochures; experience with briefing books is a plus.
  • Knowledge of FDA/ICH regulations and familiarity with eCTD templates and formatting tools.
  • Exceptional editing skills for brevity and clarity with high attention to detail.

No forms. Your profile is generated instantly.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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