30 days ago
Senior Director Medical Writing (Team Lead)
- Acts as an advisor to development functional groups on the content and optimal presentation of clinical/regulatory documents in accordance with regulatory document requirements/guidance.
- For complex regulatory submissions, oversees strategic planning and manages cross-functional authoring teams to identify key document messages and substantiate data for delivery of target labels and to minimize regulatory questions.
- Oversees and manages/supervises medical writers and contractors to ensure the highest quality of medical writing and adherence to our document standards.
- Represents Medical Writing on cross-functional initiatives/teams backing key company goals.
- Leads cross-functional process improvement initiatives on clinical document standards, template development, and document processes.
- Assists with budgetary and resource projections for oncology programs and the department.
- Author clinical/regulatory documents and perform other medical writing activities, working autonomously without direction, while ensuring effective teamwork with key contributors.
You Will Need
- Extensive clinical research and development, regulatory affairs, or related industry or academic experience in a medical writing environment, managing staff and directing and preparing documents for regulatory submissions.
- The ability to understand the needs of cross-functional teams and to lead strategy for resourcing and content of any medical writing deliverable.
- The ability to balance integrity and efficiency when managing document and submission strategy.
- Extensive knowledge of global regulatory affairs and particularly the requirements and mechanisms for regulatory approval in the United States and Europe.
- Excellent medical writing, verbal communication, and project management skills.
- Bachelor’s degree, or local equivalent.