Associate Director, Clinical Regulatory Writing

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