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 responsibly in a regulated clinical development environment. They will be able to improve efficiency while maintaining scientific rigor, traceability, compliance, and document quality. The base salary range ($220,000 - $260,000) provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.