Director Medical Writing - AI Document Lead

Position Summary We are seeking an experienced medical writer with deep expertise in clinical and regulatory documents and demonstrated experience using AI-enabled tools to support the development, review, and quality control of clinical documentation. This individual will contribute to the preparation of high-quality documents such as clinical study protocols, clinical study reports, investigator’s brochures, protocol amendments, regulatory briefing materials, and related clinical documents, while also helping to define efficient, compliant, human-in-the-loop workflows for AI-assisted document generation. The ideal candidate combines strong scientific and regulatory writing judgment with practical experience using generative AI, automation, structured content reuse, and/or document intelligence tools to improve speed, consistency, and quality in medical writing deliverables. Key Responsibilities - Author, edit, and manage clinical and regulatory documents, including protocols, CSRs, IBs, amendments, clinical summaries, and related submission-supporting materials. - Use AI-enabled tools to support drafting, summarization, content reuse, consistency checks, and document QC while ensuring all outputs are verified against approved source materials. - Develop and refine human-in-the-loop workflows for AI-assisted medical writing, including prompt strategies, source document mapping, review checkpoints, and quality controls. - Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Safety, Biostatistics, Data Management, and other stakeholders to ensure documents are scientifically accurate, submission-ready, and aligned with program strategy. - Identify opportunities to improve efficiency across medical writing processes, including document templates, libraries, automation, structured content, and cross-document consistency. - Ensure AI-assisted outputs comply with applicable SOPs, GCP, ICH guidelines, regulatory expectations, confidentiality requirements, and internal governance standards. - Support review and adjudication of cross-functional comments, ensuring clear documentation of decisions, source traceability, and final content quality. - Contribute to best practices, training, and governance for responsible use of AI in clinical and regulatory medical writing. Required Qualifications - Significant experience authoring clinical and regulatory medical writing deliverables, including protocols, clinical study reports, and investigator’s brochures. - Strong understanding of clinical development, GCP, ICH guidelines, and regulatory document standards. - Demonstrated experience using AI, automation, structured content, or advanced document-generation tools to support medical writing or clinical documentation. - Ability to critically evaluate AI-generated content for scientific accuracy, regulatory appropriateness, source alignment, and completeness. - Strong project management skills, including the ability to manage complex documents, timelines, review cycles, and stakeholder input. - Excellent written and verbal communication skills, with the ability to synthesize complex clinical and scientific information clearly and accurately. Preferred Qualifications - Experience developing AI-assisted medical writing workflows, prompt libraries, document templates, content reuse strategies, or QC frameworks. - Experience with tools such as large language models, document intelligence platforms, structured authoring systems, literature automation tools, or medical writing technology platforms. - Experience in oncology or rare disease clinical development. - Experience supporting regulatory submissions or major submission components. - Familiarity with data privacy, information security, validation, and governance considerations for AI-enabled tools in a regulated environment. Key Success Profile The successful candidate is not only an excellent medical writer, but also a practical innovator who understands how to use AI…