Director, Head of Medical Writing

BlueRock Therapeutics LP is a clinical stage cell therapy company seeking a Director, Head of Medical Writing to lead Medical Writing activities and establish a cohesive, scalable Medical Writing function to support the company's portfolio.

Requirements

• Define and own a Medical Writing strategy and roadmap that is aligned with BlueRock’s 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.
• Provide oversight and accountability for all Medical Writing deliverables across BlueRock’s portfolio, including clinical study protocols, IBs, INDs/CTAs, briefing books, Agency responses, DSURs/annual reports, CSRs, integrated summaries, and BLA/MAA modules.
• Build, lead, and develop a high-performing internal Medical Writing team, including Associate Directors and/or Principal Medical Writers.
• 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.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance