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.

Qualifications
- 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.