Sr. Director, Clinical and Regulatory Writing

Advanced degree in life sciences (M.D., or PharmD preferred); MS, PhD with significant clinical pharmacology writing experience will be considered. 12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role. Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy. Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements. Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively. Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management. Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools. Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment. Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority. Strong team orientation and passion for continuous self-development. Experience in the biotech industry or in a startup industrial setting is preferred.