Senior Director, Medical Writing

Key Responsibilities

• Lead and manage the Medical Writing team (including internal and external writers), providing guidance, mentorship, and professional development.
• Oversee the preparation, review, and submission of clinical and regulatory documents (e.g., clinical study reports, protocols, investigator brochures, regulatory submissions).
• Ensure documents are accurate, scientifically sound, and compliant with regulatory guidelines and company standards.
• Collaborate with clinical, regulatory, and scientific teams to gather and interpret data and communicate complex scientific information.
• Develop and implement medical writing processes, templates, and best practices to improve efficiency and quality.
• Stay current with industry trends, regulatory requirements, and medical writing best practices.
• Represent the Medical Writing function in cross-functional meetings and contribute to strategic planning.
• Manage timelines and resources to ensure on-time project completion.
• Other responsibilities as assigned.

• Advanced degree in life sciences, medical writing, or related field (PhD, MD, or equivalent preferred).
• 15+ years of medical writing experience in biotechnology or pharmaceutical industry.
• Proven experience leading and managing medical writers.
• Extensive knowledge of regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
• Excellent written and verbal communication skills.
• Strong problem-solving, strategic thinking, and ability to work in a fast-paced, collaborative environment.
• Outstanding scientific leadership, collaboration, interpersonal skills, and ability to manage team dynamics.