Overview
As Senior Director, you will lead a medical writing and content strategy team within Regulatory Affairs to drive high-impact regulatory submissions. You’ll guide cross-functional partners across clinical development, regulatory, and data science to shape strategic documents at the TA or portfolio level. You’ll oversee complex submissions, ensure compliance, and develop training and standards to elevate document quality. This role combines leadership with hands-on writing expertise to advance therapies that address unmet medical needs.
Responsibilities
- Lead and manage a team (direct reports, external contractors, and other people leaders) to deliver high-quality regulatory content
- Hire, develop, and retain diverse talent within the team
- Ensure compliance with established practices, policies, and regulatory requirements
- Oversee strategic planning and drafting of the most complex submissions across therapeutic areas
- Coordinate cross-functional teams to organize information and highlight key messaging and data for submissions
- Direct all deliverables and activities of the assigned team
- Communicate regulatory changes and contribute to cross-functional training programs and process improvements
- Lead special projects and represent CSD in cross-functional initiatives
- Serve as subject matter expert providing medical writing expertise for high-impact projects
Key requirements
- BA/BS or advanced degree in life sciences with significant experience leading large-scale cross-functional work, projects, and teams
- Experience in strategic planning, governance, and oversight of cross-functional initiatives
- collaboration
- leadership
- communication
- medical writing
- regulatory submissions
- content strategy and development
Sr Director, Medical Writing in London employer: GILEAD Sciences
Gilead is an exceptional employer dedicated to creating a healthier world, where every employee plays a vital role in pioneering life-changing therapies. Located in Uxbridge, our collaborative work culture fosters inclusion and empowerment, providing ample opportunities for professional growth and development. With a strong focus on leadership and continuous improvement, Gilead offers a unique environment that encourages innovation and meaningful contributions to global health challenges.
