Associate Director, Clinical Regulatory Writing
AstraZeneca
Full-time
Remote friendly (Gaithersburg, MD)
United States
Clinical Research and Development
Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Associate Director, Clinical Regulatory Writing – lead strategic communications in clinical regulatory writing, ensuring documents align with project strategies and regulatory requirements across drug and non-drug projects.
Responsibilities
- Manage clinical regulatory writing activities across a portfolio to meet regulatory, technical, and quality standards.
- Lead submission teams and drive development of communication strategies.
- Collaborate with internal and external authoring teams.
- Interpret complex data and deliver clear messages that meet customer information needs.
- Support the development of others in the team and drive continuous improvement in communications leadership.
Qualifications
- Required: Life Sciences degree in an appropriate discipline.
- Required: Significant medical writing experience in the pharmaceutical industry or CRO.
- Required: Ability to advise and lead communication projects.
- Required: Understanding of drug development and the communication process from development, launch through life cycle management.
- Required: In-depth knowledge of the technical and regulatory requirements related to the role.
- Preferred: Advanced degree in a scientific discipline (Ph.D.).
Skills
- Strategic writing and communications leadership
- Regulatory and technical writing for clinical drug development
- Cross-functional collaboration and team development
- Data interpretation and clear message development
Education
- Life Sciences degree (required); Ph.D. preferred.
Additional Requirements
- None