Strategic Medical Writing Director for Regulatory Document Excellence
1 month ago
About the Role:
Gilead Sciences, Inc. is a leader in the development of innovative therapies that address some of the world's most pressing health challenges. We are seeking an experienced Associate Director to join our dynamic Medical Writing team.
Key Responsibilities:
- Develop and author high-quality regulatory documents, including clinical study reports, investigator's brochures, CTD summaries, and regulatory responses, with minimal supervision.
- Provide strategic guidance on regulatory document strategies and represent Medical Writing on cross-functional teams, including regulatory submissions and product lifecycle management.
- Serve as a senior medical writer and department representative for large development programs or therapeutic areas, providing expertise to less experienced colleagues and contractors.
- Participate in process improvement initiatives to enhance document standards, template development, and document processes.
- May lead or advise others on complex projects, review documents written by less experienced writers, and oversee the work of external contractors.
Requirements:
- Bachelor's degree in life sciences or related field; advanced degree preferred.
- Significant experience in medical writing in the biopharma industry, with a track record of leading medical writing or related deliverables and setting strategies for biopharmaceutical products.
- Demonstrated expertise in regulatory documentation, with in-depth knowledge of current global and regional trends.
- Strong leadership presence, with ability to lead without authority and influence programs, projects, and initiatives.
- Able to travel when needed.
Compensation and Benefits:
We offer a competitive salary of $180,000 per year, commensurate with experience, plus a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
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