Associate Director, R&I Clinical Regulatory Writing (CReW)

Role: Associate Director, R&I Clinical Regulatory Writing (CReW), provides strategic leadership and manages clinical regulatory document development within a pharmaceutical/biotech setting, focusing on ensuring high-quality submissions and process efficiencies. Responsibilities: independently oversee clinical regulatory writing across projects, author and review submission documents, develop communication strategies, lead internal/external writing teams, and drive continuous operational improvements. Requirements: Bachelor's degree, 5+ years in medical/regulatory writing within pharma/biotech or CRO, experience leading submission authoring, and understanding of drug development processes. Preferred: advanced scientific degree (Ph.D.). High-value: roles involve strategic document preparation for clinical trial submissions, supporting life-cycle management, with expertise in regulatory standards and cross-functional collaboration. Work setup: not specified.