Associate Director, Clinical Regulatory Writing (CReW)

Role: Associate Director of Clinical Regulatory Writing at AstraZeneca, leading strategic communication efforts for clinical-regulatory documentation across a portfolio of oncology and other therapeutic programs. Responsibilities: independently manage clinical regulatory writing activities, author and oversee the development of key documents ensuring compliance with regulatory standards, provide strategic leadership within submission teams, develop clinical Submission Communication Strategies, lead internal/external authoring teams and vendor writers, interpret complex clinical data into clear messages, and support continuous improvement. Requirements: Bachelor's in Life Sciences, 5+ years of medical writing experience in pharma or CRO, strong understanding of drug development and regulatory processes, ability to lead projects and teams. Preferred: Ph.D. in scientific field. High-Value: experience in oncology, clinical development stages from early to post-market, expertise in regulatory documentation, strategic communication, and submission planning. Work Setup: not explicitly stated.