Job

Senior Director Medical Writing (Team Lead)

Key Responsibilities

• 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.

#LI-FJ1