Director, Head of Medical Writing

Director, Head Of Medical Writing

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's lead program in clinical development is pociredir, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. The company's proprietary product engine identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression.

The Director, Head of Medical Writing, will report to the Head of Regulatory Affairs & Quality Assurance and collaborate cross-functionally with colleagues in Discovery, Clinical Development, Medical Affairs, and Regulatory. This individual will lead the development and delivery of a broad range of clinical and regulatory, documents to support the company's drug development programs.

Initially, this role will oversee an outsourced model for medical writing activities. Over time, the Director will be responsible for building and managing an internal medical writing team that is appropriately resourced to meet the evolving needs of the organization. The ideal candidate will combine hands-on writing expertise with strategic leadership to ensure timely delivery of high-quality documents.

Strategic Leadership & Operational Execution :

• Develop and implement a scalable, fit-for-purpose medical writing delivery model that balances internal and external resources
• Lead the planning, preparation, and review of high-quality clinical, regulatory, and publication documents in collaboration with cross-functional teams
• Ensure consistency, accuracy, and compliance with applicable regulatory and scientific guidelines and standards
• Serve as a subject matter expert in medical writing and provide direct writing support as needed

Document Ownership : Clinical Documents :

Regulatory Documents :

Qualifications :

Base Salary Pay Range $175,000 - $191,000 USD