Associate Director, Clinical Regulatory Writing
Core
Strategic communications leadership for clinical regulatory submissions, authoring high-quality regulatory documents, and managing vendor teams to ensure accelerated delivery.
Role type
Associate Director, Clinical Regulatory Writing (CReW)
Builds
Clinical submission packages and regulatory documents for pharmaceutical programs
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Required skills
Clinical regulatory writing, submission authoring, strategic communication, vendor management, drug development lifecycle knowledge, complex data interpretation, operational excellence
Preferred skills
PhD in a scientific discipline
Technologies
Regulatory submission platforms, document management systems
Responsibilities
Independently manage clinical regulatory writing activities across a portfolio; Author clinical-regulatory documents ensuring regulatory and quality standards; Drive the development of the clinical Submission Communication Strategy; Lead internal/external authoring teams and partner with vendor medical writers; Drive the clinical interpretation of complex data into clear messages; Support the development of others in Clinical Regulatory Writing
Seniority
Associate Director, strategic leadership with hands-on authoring
