Fulcrum Therapeutics
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 :
Investigator Brochures
Protocol Synopses, Protocols, and Amendments
Informed Consent Forms
Clinical Study Reports (CSRs), Safety Narratives
Regulatory Documents :
Annual Reports, Safety Updates
Briefing Documents, Regulatory Correspondence
Clinical Trial and Marketing Applications in eCTD format, including INDs, CTAs, NDAs / sNDAs, MAAs
Qualifications :
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
We offer a hybrid work model, with employees expected to be onsite at least 50% of the time.
Base Salary Pay Range $175,000 - $191,000 USD
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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 :
Investigator Brochures
Protocol Synopses, Protocols, and Amendments
Informed Consent Forms
Clinical Study Reports (CSRs), Safety Narratives
Regulatory Documents :
Annual Reports, Safety Updates
Briefing Documents, Regulatory Correspondence
Clinical Trial and Marketing Applications in eCTD format, including INDs, CTAs, NDAs / sNDAs, MAAs
Qualifications :
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
We offer a hybrid work model, with employees expected to be onsite at least 50% of the time.
Base Salary Pay Range $175,000 - $191,000 USD
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