Director, Regulatory Medical Writing
Fulcrum TherapeuticsCambridge, Massachusetts, United States
Posted October 1, 2025
175000 - 191000 USD year
Full Time
About the Company
Fulcrum Therapeutics is a clinical-stage biopharmaceutical company dedicated to advancing treatments for genetically defined diseases, particularly rare conditions. The company specializes in gene regulation and neuromuscular diseases, offering innovative solutions with a focus on high unmet medical needs. Fulcrum's distinctive approach leverages cutting-edge technology to improve patient outcomes.
Job Description
Fulcrum Therapeutics is seeking a Director of Regulatory Medical Writing to lead the development and delivery of clinical and regulatory documents to support drug development programs. The role involves leadership, operational execution, and ensuring adherence to regulatory guidelines. The company is a clinical-stage biopharmaceutical focused on improving the lives of patients with rare diseases.
Requirements
- PhD in biological science is preferred
- Minimum of 10 years of medical writing experience in the biopharmaceutical industry or CRO setting
- Proven leadership experience managing teams
- Deep knowledge of GCP, ICH, and CFR regulatory requirements
- Proficiency in scientific literature research methods
- Strong technical proficiency with tools such as Adobe Acrobat Pro, Microsoft Office Suite, and EndNote
- Hybrid work model (at least 50% onsite)
