Director, Medical Writing

Role Summary

The Director, Medical Writing leads document strategy, overseeing authoring and review processes and the writing of assigned regulatory documents. They coordinate internal writers and external contract writer groups, establish best practices, and ensure high-quality submissions in compliance with regulatory guidelines for global health authority submissions.

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 and thought leaders 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).
• Ensure smooth document management from drafting to final approved version, including bibliographies and adherence to style guides.
• Support development, implementation, and improvement of best practices, document processes, and SOPs.
• Develop and maintain templates/outlines for key documents and ensure adherence and appropriate adjustments.
• Provide leadership of matrix teams.
• Demonstrate a track record of high-quality preclinical, clinical development, regulatory, and scientific documents, including protocols, CSRs, BLA/NDA/MAA CTD submission documents, investigator brochures, briefing documents, and regulatory responses.
• Display in-depth knowledge of drug/biologic development, approval processes, and GxP principles.
• Show strong leadership, planning, and project management, with initiative and ability to work with minimal supervision.
• Collaborate to coordinate team efforts to resolve comments and meet 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 self-management aligned with corporate goals.
• Proficiency with Microsoft Office and electronic document management systems.
• Experience responding to company and regulatory audits.

Qualifications

• Bachelor‚Äôs degree in a scientific discipline; advanced degree (MS, PhD, PharmD, MD) desirable.
• 8‚Äì12 years of experience in medical or scientific writing in the pharmaceutical/biotech industry for Bachelor's degree; 6‚Äì8 years with advanced degree.