Director, Regulatory Medical Writing

Third Rock Ventures • Cambridge, MA

76d • $175,000 - $191,000 • Hybrid

About The Position

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, Regulatory 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.

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 of full-time employees and/or contractors
• Deep knowledge of GCP, ICH, and CFR regulatory requirements; familiarity with Health Canada, MHRA, PMDA, and EMA guidelines
• Proficiency in scientific literature research methods; familiarity with AMA, APA, CSE, and Chicago style guides
• Understanding of publication guidelines including GPP2, ICMJE, and CONSORT
• Strong technical proficiency with tools such as Adobe Acrobat Pro, Microsoft Office Suite (Word, Excel, PowerPoint, Teams, Project, SharePoint), and EndNote

Responsibilities

• 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
• Oversee the development of Investigator Brochures, Protocol Synopses, Protocols, and Amendments, Informed Consent Forms, Clinical Study Reports (CSRs), and Safety Narratives
• Manage the preparation of Annual Reports, Safety Updates, Briefing Documents, Regulatory Correspondence, and Clinical Trial and Marketing Applications in eCTD format, including INDs, CTAs, NDAs/sNDAs, MAAs

Benefits

• Hybrid work model with employees expected to be onsite at least 50% of the time

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Securities, Commodity Contracts, and Other Financial Investments and Related Activities
• Education Level: Ph.D. or professional degree