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Fulcrum Therapeutics · 4 days ago

Director, Head of Medical Writing

Cambridge, MA

Full-time

Hybrid

Director/Executive

$175K/yr - $191K/yr

10+ years exp

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases. The Director, Head of Medical Writing, will lead the development and delivery of clinical and regulatory documents to support the company’s drug development programs, while overseeing an outsourced model and eventually building an internal team.

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

Medical writing experienceGCPICHCFR knowledgeLeadership experienceScientific literature researchRegulatory document preparationAdobe Acrobat ProMicrosoft Office SuiteEndNote proficiencyPublication guidelines understanding

Required

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