Director, Head of Medical Writing Job at Fulcrum Therapeutics in Cambridge
Fulcrum Therapeutics, Cambridge, MA, United States, 02140
Join to apply for the Director, Head of Medical Writing role at Fulcrum Therapeutics
2 days ago Be among the first 25 applicants
Join to apply for the Director, Head of Medical Writing role at Fulcrum Therapeutics
Company Overview
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.
Company Overview
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.
Description
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.
Responsibilities
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
Clinical Documents
- 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
- 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.
$175,000—$191,000 USD
Seniority level
Seniority level
Director
Employment type
Employment type
Full-time
Job function
Job function
Health Care Provider
Referrals increase your chances of interviewing at Fulcrum Therapeutics by 2x
Get notified about new Medical Director jobs in Cambridge, MA.
Boston, MA $250,000.00-$315,000.00 3 weeks ago
Pioneering Medicines: Executive Director (MD), Therapeutic Innovation
Senior Director, Global Medical Information
Boston, MA $160,000.00-$180,000.00 2 weeks ago
Medical Operations Manager/ Practice Manager
Director / Senior Director, Clinical Sciences
Waltham, MA $205,000.00-$270,000.00 1 week ago
Director of Health Services (Registered Nurse)
Newton Centre, MA $90,000.00-$110,000.00 3 weeks ago
Regional Medical Director (Remote - Multiple Locations)
Waltham, MA $194,000.00-$267,000.00 3 days ago
Associate Director/Director, Clinical Operations
Cambridge, MA $180,000.00-$230,000.00 2 days ago
Boston, MA $160,000.00-$180,000.00 6 days ago
Lexington, MA $191,800.00-$301,400.00 2 weeks ago
Senior Director Dermatology, Global Medical Affairs
Chief Medical Officer, Global Oncology Business Unit
Cambridge, MA $336,000.00-$462,000.00 2 weeks ago
Cambridge, MA $200,000.00-$225,000.00 2 days ago
Boston, MA $269,000.00-$340,200.00 2 weeks ago
Boston, MA $250,000.00-$300,000.00 3 weeks ago
Senior Manager, Global Contact Center & Medical Information Operations
Head (Executive Director) Rare Disease, US Medical Affairs
Cambridge, MA $296,000.00-$418,000.00 2 months ago
Director of Nursing - $10,000 Sign-On Bonus
Greater Boston $270,000.00-$300,000.00 2 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr