Director, Strategic Medical Writing

The Director, Strategic Medical Writing directs centralized clinical writing function across therapeutic areas and/or multiple drug programs within Development, ensuring successful preparation of high quality, submission-ready documents and effective management of the clinical writing process in accordance with clinical and regulatory timelines. Oversees business systems that support clinical regulatory document creation. Provides leadership in regulatory document development and submission strategy and expertise in project management for documents for multiple compounds, therapeutic areas (both large and small), and regulatory submissions. Ensures accurate and timely completion, review, and, delivery of information for regulatory submissions. Determines resource needs, prepares tactical plans to ensure adequate resourcing, and manages internal and outsourced personnel. Determines outsourcing strategy and ensures expectations with vendors by the Senior Managers, Medical Writing responsible for strategy implementation. Maintains expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation and serves as a company-wide subject matter expert and liaison for other functions to ensure the application of highest industry standards. Maintains inspection readiness for assigned remit. Acts as the organizational representative in regulatory inspections and quality audits. This role offers the flexibility to work remotely