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.

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%.

Director, Head of Medical Writing

Key skills