Director, Medical Writing

Role Summary

Director, Medical Writing leading document strategy, authoring, and review for regulatory submissions, coordinating internal and external writers, and ensuring compliance with ICH/GCP/regulatory guidelines for global health authority submissions such as IND/CTR/CTA/BLA/sBLA.

Responsibilities

• Lead planning, authoring, and critical review of regulatory documents (e.g., Protocols, CSRs, IB, health authority briefing documents).
• Evaluate/review documents from internal and external writers to ensure consistency with objectives, formatting, nomenclature, and scientific approach across projects.
• Engage with external stakeholders such as vendors, thought leaders, or other groups as needed.
• Develop and manage timelines for authoring, review, and finalization of critical documents and deliverables.
• Assess medical writing needs and ensure adequate resourcing (in-house and/or by consultant/CRO support).
• Ensure smooth document management from draft to final approved version, including drafting, coordinating reviews, generating bibliographies, and adhering to style guides.
• Support development, implementation, and improvement of best practices, document processes, and SOPs.
• Develop and maintain templates/outlines for key documents; ensure adherence and adjustments as needed.
• Lead matrix teams.
• Demonstrate track record of high-quality preclinical, clinical development, regulatory, and scientific documents, including protocols, CSR, BLA/NDA/MAA/CTD submissions, investigator brochures, briefing documents, and responses to regulatory questions.
• Show knowledge of drug/biologic development and approval processes and GxP principles.
• Exhibit strong leadership, planning, and project management, with initiative and ability to work with minimal supervision.
• Collaborate to resolve comments and complete deliverables; facilitate comment resolution meetings to reach final agreement on approach.
• Manage/prioritize multiple projects in a fast-paced environment; adapt to changing deadlines and priorities.
• Demonstrate strong written, verbal, and interpersonal communication; high attention to detail; self-motivation and alignment with corporate goals.
• Proficiency with Microsoft Office and experience with electronic document management systems.
• Experience responding to company and regulatory audits.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree desirable (MS, Ph.D., PharmD, MD).
• 8–12 years of experience in medical or scientific writing in the pharmaceutical or biotech industry for Bachelor's degree level; 6–8 years’ experience with advanced degree (MS, Ph.D., PharmD, MD).