Director, Head of Medical Writing
About The Position
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinsonâs disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patientsâ lives. The Head of Medical Writing will provide strategic and operational leadership for all Medical Writing activities to support BlueRockâs portfolio, from early development through product registration. This role is accountable for establishing and overseeing a cohesive, scalable Medical Writing function that delivers high-quality regulatory documents that are aligned with BlueRockâs global strategy, development timelines, and corporate priorities. The Head of Medical Writing will develop and lead an internal medical writing team, oversee vendor partnerships, and serve as a key strategic partner to Regulatory Affairs, Pharmacovigilance, Clinical Development, Clinical Operations, Biometrics, Translational Science, and Technical Operations. This role will also 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; Bachelorâs 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%.
Responsibilities
- Define and own a Medical Writing strategy and roadmap that is aligned with BlueRockâs pipeline, regulatory milestones, and long-term growth.
- Establish standards, processes, and governance to ensure consistency, quality, and inspection readiness across all Medical Writing deliverables.
- Partner with Regulatory Affairs leadership to ensure that Medical Writing is fully integrated into regulatory strategy, Regulatory Agency engagement, and submission planning.
- Drive a platform-based approach to document development, enabling efficiencies and reuse of content across programs where appropriate.
- Represent Medical Writing in cross-company forums as needed.
- Provide oversight and accountability for all Medical Writing deliverables across BlueRockâs portfolio, including clinical study protocols, IBs, INDs/CTAs, briefing books, Agency responses, DSURs/annual reports, CSRs, integrated summaries, and BLA/MAA modules.
- Ensure delivery of documents that are on time, of high quality, and aligned with evolving global regulatory expectations.
- Identify opportunities to improve speed, quality, and scalability of document development.
- Lead resource planning (internal FTEs and external medical writing vendors) to support current and future program needs.
- Oversee and manage vendors and consultants to ensure consistent value, quality, and alignment.
- Serve as escalation point for complex document development challenges.
- Build, lead, and develop a high-performing internal Medical Writing team, including Associate Directors and/or Principal Medical Writers.
- Provide coaching, mentoring, and performance management to support professional growth and retention.
- Foster a culture of accountability, collaboration, and continuous improvement
- Lead initiatives to modernize Medical Writing activities, including evaluation and pilot implementation of:
- AI-enabled authoring, QC reviews, and content reuse tools
- Digital workflows and submission efficiencies
- Define and manage collaboration models with Bayer, including potential shared services and/or AI-enabled pilots.
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What This Job Offers
Job Type
Full-time
Career Level
Director
