Director, Head of Medical Writing
BlueRock Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • United States
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Salary
💰 $198,000 - $233,300 per year
Job Level
About the role
- Provide strategic and operational leadership for all Medical Writing activities to support BlueRock’s portfolio, from early development through product registration.
- Establish and oversee a cohesive, scalable Medical Writing function that delivers high-quality regulatory documents that are aligned with BlueRock’s global strategy, development timelines, and corporate priorities.
- Develop and lead an internal medical writing team, oversee vendor partnerships.
- Serve as a key strategic partner to Regulatory Affairs, Pharmacovigilance, Clinical Development, Clinical Operations, Biometrics, Translational Science, and Technical Operations.
- Help shape future-state capabilities, including AI-enabled medical writing, platform-based content reuse, and collaboration models with Bayer colleagues.
Requirements
- PhD, PharmD, MD, or other advanced degree in a scientific/medical discipline preferred; Bachelor’s degree required.
- 10+ years of medical writing experience within the biopharma industry; experience with cell and/or gene therapies strongly preferred.
- Demonstrated leadership of global regulatory writing programs, including INDs/CTAs and marketing applications (BLAs/MAAs).
- Deep understanding of drug and biologics development, CTD structure, ICH and GxP guidelines, regulatory interactions, and submission processes.
- Proven leadership, including building and managing teams.
- Strong strategic thinking combined with hands-on execution capability.
- Excellent written and verbal communication skills.
- Experience working cross-functionally in fast-paced, matrixed organizations.
- Familiarity with document management systems and authoring tools (eg, Veeva, SharePoint, StartingPoint).
- Ability to travel within US/Canada (and limited EU travel, potentially) up to 20%.
Benefits
- Equal Opportunity Workplace
- Support for differences and diversity
- Disability-related accommodation during recruitment process
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingregulatory writingINDsCTAsBLAsMAAsdrug developmentbiologics developmentCTD structureICH guidelines
Soft Skills
leadershipstrategic thinkingcommunicationteam managementcross-functional collaborationexecution capability
Certifications
PhDPharmDMD