The Head of Medical Writing will provide strategic and operational leadership for all Medical Writing activities to support BlueRock’s portfolio, from early development through product registration. Accountable for establishing and overseeing a cohesive, scalable Medical Writing function that delivers high-quality regulatory documents aligned with BlueRock’s global strategy, development timelines, and corporate priorities. Develop and lead an internal medical writing team, oversee vendor partnerships, and serve as a key strategic partner to various departments. Help shape future-state capabilities, including AI-enabled medical writing, platform-based content reuse, and collaboration models with Bayer colleagues. Define and own a Medical Writing strategy and roadmap 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 integration of Medical Writing into regulatory strategy, Agency engagement, and submission planning. Drive a platform-based approach to document development for efficiencies and content reuse. Represent Medical Writing in cross-company forums as needed. Operational Excellence Provide oversight and accountability for all Medical Writing deliverables across BlueRock’s portfolio. 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. 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. Define and manage collaboration models with Bayer, including potential shared services and/or AI-enabled pilots.