Associate Director, Medical Writing and AI Implementation

Role Summary 

The Associate Director, Medical Writing will support the Medical Writing function at Lexeo, working cross-functionally to generate and manage the development of clinical and regulatory documents. This role will also take a lead in implementing artificial intelligence (AI) tools to drive optimization and efficiency in all aspects of regulatory and medical writing. This role will be responsible for the planning, development, and oversight of study and program level documents with a focus on accuracy, quality, and compliance. Additionally, the role will manage medical writing and regulatory operations resources, including vendors and partners, and contribute to process improvement initiatives. 

Primary Responsibilities

• Draft and contribute to the development of high-quality submission-ready documents such as protocols, protocol amendments, clinical study reports, investigational new drug applications (INDs)/clinical trial applications (CTAs)/biologics license applications (BLAs) modules, regulatory designations, lifecycle maintenance documents, briefing documents, or others as needed.  

• Ensure the quality of deliverables by conducting editorial reviews of documents (grammar, punctuation, consistency) and completing or managing the quality checking of documents according to Lexeo standards. 

• Manage the document development process for deliverables including planning aspects (timeline development, kick-off meetings, communicating scope and accountabilities), project execution (tracking/monitoring progress according to established timelines, conducting team meetings), and project finalization (ensuring final agreed content, approval, quality, and compliance). 

• Publish documents for submission and/or oversee Regulatory Operations vendors as needed and review published documents prior to submission. Use AI and automation to support publishing activities such as document formatting, hyperlinking, and validation checks. Ensure final submission packages (e.g., eCTD sequences) are complete, correctly formatted, and pass technical quality standards. Collaborate with Regulatory Operations to troubleshoot any document formatting or technical issues, leveraging AI tools for efficiency where possible. 

• Use AI capabilities and implement new AI of appropriate scope to improve efficiencies and optimize processes of all activities related to Regulatory and Medical Writing. 

• AI Tools Evaluation & Implementation: Research, evaluate, and implement AI-powered tools to enhance the regulatory, medical writing, and publishing process. Identify appropriate AI solutions (e.g., for text generation, summarization, consistency checks, or document formatting) that fit the organization’s scale and needs. Lead pilot projects to test these tools and measure their impact on efficiency and quality.  

• AI-Driven Process Optimization: Drive the integration of AI technologies into daily medical writing activities to automate or streamline routine tasks. For example, deploy AI assistance for initial draft generation of certain sections, automatic formatting or indexing for eCTD submissions, content comparison for consistency across documents, and automated quality checks for style and reference accuracy. Ensure that such implementations adhere to regulatory guidelines and data privacy requirements while delivering efficiency gains.  

• Training and Change Management: Act as the lead for training the medical writing (and regulatory and clinical development as appropriate) team(s) on new AI/digital tools and updated workflows. Develop user guidelines or job aids and conduct hands-on training sessions to help writers and reviewers effectively use AI tools (e.g., AI content generators or QC software). Provide ongoing support and champion user adoption to maximize the tools’ benefits, while also gathering feedback to refine tool use-cases. 

• Process Improvement & Innovation: Continuously monitor emerging trends and best practices in medical writing and AI. Pr