Global Head of Medical Writing

Overview:Global Head of Medical Writing - AIReports to SVP, Global Head of Clinical Sciences and OperationsWe are seeking a visionary and strategic Global Head of Medical Writing to lead our worldwide medical writing organization. In this critical leadership role, you will oversee a globally distributed team of direct reports while strategically managing a Functional Service Provider (FSP) model to ensure the seamless delivery of high-quality clinical and regulatory documents.As a forward-thinking leader, you will be the primary champion for modernizing our medical writing capabilities. You will bring experience or capability to integrate Artificial Intelligence (AI) and Generative AI (GenAI) to identify opportunities, drive digital transformation, and deliver next-generation writing solutions that reduce cycle times, enhance quality, and streamline global regulatory submissions. Responsibilities:Global Team Leadership & FSP Management Direct Leadership: Lead, mentor, and develop a high-performing, globally distributed team of internal medical writers and managers. Cultivate a culture of scientific rigor, continuous learning, and innovation.FSP Strategy & Oversight: Manage and optimize our global FSP partnership model. Ensure scalable resource allocation, monitor key performance indicators (KPIs), and maintain seamless integration between internal teams and FSP resources.Resource Allocation: Dynamically forecast and balance workloads across internal staff and FSP partners to meet dynamic pipeline demands efficiently.Role Evolution: Lead the transition from a traditional medical writing model to an "AI-augmented editor" framework. This involves leveraging artificial intelligence to drive workflow efficiencies, optimize time management, and increase agility. Additionally, the role will utilize AI-driven data mining to expand information reach, ensuring the creation of robust, highly accurate, and comprehensive medical documents.AI Strategy, Opportunities, & Innovation AI Vision & Roadmap: Define and execute a multi-year strategy for integrating AI, and automation into the medical writing lifecycle.Process Transformation (Opportunities): Identify high-value opportunities to leverage AI for data-to-text automation (e.g., automated patient narratives, CSR generation, and protocol drafting) while maintaining strict regulatory compliance and data privacy.Change Management: Act as the strategic ambassador for AI adoption, guiding the global team and FSP partners through the cultural and technical shifts required to embrace AI-assisted workflows.The "Human-in-the-Loop" Mandate: Establish protocols ensuring that an experienced human interface (such as m writer) signs off on every automated sentence to prevent AI "hallucinations" in regulatory documents.Medical Writing Deliverables & Compliance Portfolio Oversight: Ensure the timely, accurate, and compliant delivery of all clinical and regulatory documents, including Investigators Brochures (IBs), Clinical Study Protocols, Clinical Study Reports (CSRs), and CTD modules for NDA/MAA submissions.Quality & Standards: Establish and enforce global medical writing standards, SOPs, and templates, ensuring alignment with ICH, GCP, and other global regulatory guidelines.Audit Trail Compliance: Ensuring that the validation process for any AI-assisted document is fully documented and "inspection-ready" for regulatory audits (FDA/EMA).Cross-Functional Collaboration: Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, and Clinical Development to align on study and submission timelines.Plain Language Summaries (PLS): Responsible for generating patient-centric, layperson summaries of clinical trial results, which are legally mandated in many regions (like the EU CTR).Trial Registries: Management of disclosures on sites like ClinicalTrials.gov and EudraCT.Key AI Deliverables Expected in Year One AI Readiness Assessment: Deliver a comprehensi