Associate Director, Clinical Regulatory Writing (CReW)
Core
Lead clinical regulatory writing for drug projects, authoring label-focused documents that align with project strategies and regulatory requirements to support successful submissions and approvals.
Role type
Associate Director, Clinical Regulatory Writing (IC with leadership)
Builds
Clinical-regulatory documents and submission communication strategies for pharmaceutical drug projects
Domain
Life Sciences / Oncology / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, strategic communications leadership, drug development lifecycle knowledge, regulatory requirements expertise, vendor management, data interpretation, operational excellence
Preferred skills
Ph.D. in a scientific field
Technologies
None stated
Responsibilities
Manage clinical regulatory writing activities across a portfolio; author clinical-regulatory documents ensuring regulatory and quality standards; provide strategic communications leadership to projects; drive development of clinical Submission Communication Strategy; lead internal/external authoring teams and partner with vendor medical writers; drive clinical interpretation of complex data into clear messages; support development of others in Clinical Regulatory Writing
Seniority
Associate Director, hands-on IC with strategic oversight
