Fulcrum Therapeutics · 22 hours ago
Senior Director or Director, Head of Medical Writing (Hybrid)
Cambridge, MA
Full-time
Hybrid
Director/Executive
$190K/yr - $260K/yr
10+ years expFulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases. The Senior Director or Director, Head of Medical Writing, will lead the development and delivery of clinical and regulatory documents to support the company’s drug development programs.
BiotechnologyGeneticsHealth CareTherapeutics
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
Investigator Brochures
Protocol Synopses, Protocols, and Amendments
Informed Consent Forms
Clinical Study Reports (CSRs), Safety Narratives
Annual Reports, Safety Updates
Briefing Documents, Regulatory Correspondence
Clinical Trial and Marketing Applications in eCTD format, including INDs, CTAs, NDAs/sNDAs, MAAs
Qualification
Required
Minimum of 10 years of medical writing experience in the biopharmaceutical industry or a 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 and Microsoft Office Suite (Word, Excel, PowerPoint, Teams, Project, SharePoint)
Hybrid work model, with employees expected to be onsite at least 50% of the time
Preferred
PhD preferred, but not required
Company
Fulcrum Therapeutics
Fulcrum Therapeutics is a biotechnology company that focuses on identifying and treating rare genetic diseases at their root cause.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$778.3MKey Investors
Foresite CapitalGoogle VenturesThird Rock Ventures
2025-12-10Post Ipo Equity· $175M
2023-01-17Post Ipo Equity· $125M
2022-08-15Post Ipo Equity· $75M
Leadership Team
Alan A. Musso
Chief Financial Officer
Jeff Jacobs
Chief Scientific Officer and Head of Technical Operations
Recent News
2025-12-11
Company data provided by crunchbase