Associate Director, R&I Clinical Regulatory Writing (CReW)
Core
Strategic communications leadership for clinical delivery and submission teams, establishing standards and authoring high-quality clinical-regulatory documents.
Role type
Associate Director, Clinical Regulatory Writing (CReW)
Builds
Clinical submission packages and communication strategies for drug and non-drug projects
Domain
Pharmaceutical/Biotech, Clinical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic communications leadership, clinical-regulatory document authoring, submission strategy development, vendor team leadership, complex data interpretation, strategic review capabilities, operational excellence
Preferred skills
Advanced degree in a scientific discipline (Ph.D.)
Technologies
None stated
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; drive continuous improvement and operational excellence from a communications leadership perspective
Seniority
Senior, hands-on IC with strategic oversight
