Clinical Regulatory Writing Manager (Associate Director)

Role Summary

Clinical Regulatory Writing Manager (Associate Director) responsible for leading clinical regulatory writing activities, authoring complex documents, and providing strategic communications leadership to ensure high-quality, timely submissions in support of drug development programs.

Responsibilities

• Independently manage clinical regulatory writing activities across a complex portfolio of work.
• Author the most complex clinical-regulatory documents within a program, ensuring regulatory, technical, and quality standards are met.
• Provide strategic communications leadership to projects, establishing communication standards and advocating for quality and efficiency.
• Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead.
• Lead internal/external authoring teams and partner with vendor medical writers to ensure timely and quality delivery.
• Interpret complex data and information, condensing it into clear, concise messages that meet customer information requirements.
• Demonstrate strategic thinking and review capabilities.
• Collaborate proactively with other functions at the program level.
• Support the development of Clinical Regulatory Writing Managers.
• Drive continuous improvement and operational excellence from a communications leadership perspective.

Qualifications

• Required: BS Life Sciences degree in an appropriate discipline.
• Required: Significant (7+ yrs) medical writing experience in the pharmaceutical industry or CRO.
• Required: Ability to advise and lead communication projects.
• Required: Understand drug development and 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 communications leadership
• Regulatory writing and document development
• Cross-functional collaboration
• Vendor management and team leadership
• Data interpretation and concise messaging

Education

• BS in Life Sciences (required); Ph.D. preferred.

Additional Requirements

• Hybrid role – minimum requirement 3 days per week onsite.