Associate Director, Medical Writing and AI Implementation

Job description

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 (gra...