Director, Medical Writing

Role: Lead medical writing for global biopharmaceutical clinical development programs, overseeing the creation of regulatory documents to support submissions. Responsibilities: develop and manage clinical and regulatory documents such as IBs, CSRs, and marketing submissions, ensuring accuracy, consistency, and compliance with ICH and global standards; coordinate internal and external writing activities; participate in process improvement initiatives; oversee contract writers and potentially manage staff; contribute to departmental strategy and SOPs. Requirements: bachelor's degree (advanced preferred); over 10 years of medical writing experience in biopharma or CROs; strong understanding of clinical data interpretation, project management, and global regulatory requirements across various therapeutic areas; proficient in MS Word and electronic document management systems. High-value: extensive global regulatory document development experience, leadership in cross-functional teams, knowledge of clinical development stages, and therapeutic areas. Work setup: not specified; likely office-based or hybrid given senior leadership and cross-functional interaction.