Associate Director, Medical Writing, AI Implementation

Role Overview

• 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. Propose and lead process improvement initiatives that enhance document quality or team productivity – for example, developing standard content libraries, improving templates, or introducing structured content management approaches in combination with AI. Maintain up-to-date knowledge of regulatory expectations regarding the use of AI in document preparation to ensure responsible implementation.
• Oversee vendor identification, engagement, and management to enable completion of objectives and corporate priorities as requested.
• Identify and implement organizational efficiencies for document development and quality, document management, and submission management.
• Facilitate the development and maintenance of standard processes and style guides.
• Serve as a StartingPoint Administrator, managing template upgrades, internal user support, and cross-departmental training.
• Contribute to department initiatives and other duties in support of clinical development as needed, including in the development of AI tools and technology. This may include determining appropriate vendors and tools, disseminating information to the team, and conducting training on new AI technologies.

Requirements

• A bachelor's degree is required; a graduate degree (Master's or Ph.D.) is strongly preferred. At least one of these degrees must be in a scientific discipline.
• Minimum of 8 years experience with at least 4 to 6 years working as a medical writer within a pharmaceutical/biotech company or CRO.
• Understanding of, and experience using, AI tools available to aid in medical writing with direct experience implementing AI tools in a Regulatory/Medical Writing/Clinical Development setting strongly preferred.
• Direct experience leading the development of protocols and amendments, clinical study reports (CSRs), IBs, and the ability to generate most types of clinical and regulatory medical writing deliverables.
• Working knowledge of the content and format of the electronic Common Technical Document (eCTD) and document publishing specifications.
• Thorough knowledge of the drug development process and applicable regulatory requirements and guidelines (e.g., ICH E3, E6, E9).
• Advanced writing and speaking competency, positive and proactive written and verbal communication skills.
• Experience across all phases of clinical development and with most types of regulatory and clinical documents, including highly complex documents.
• Demonstrated ability to translate complex technical information from mixed sources into written information suitable for an audience of clinicians and health authorities.
• Demonstrated high attention to detail in overall document consistency and strategic presentation of information.
• Ability to manage multiple projects simultaneously in a fast-paced environment.
• Proficiency in Microsoft Office Suite (including MS Project and Copilot) and Adobe Acrobat as well as authoring toolbars and template suites (Starting Point experience preferred) and reference software (Endnote).
• Ability to adapt and work effectively in changing situations and different program teams.
• Keep informed of new regulations and guidance.
• Ability to work Eastern Time Zone
• Ability to travel to NY HQ as needed.