Senior Director, Medical Writing

Role: Senior Director, Medical Writing, overseeing the development and leadership of clinical and regulatory documents for biopharmaceutical products. Objectives include ensuring high-quality, scientifically rigorous submissions aligned with regulatory standards. Responsibilities encompass strategic leadership within medical writing, resource management, vendor oversight, and collaboration with legal and finance for contract negotiations. The role involves managing internal writers and external vendors, maintaining documentation standards, and supporting regulatory submissions, including global marketing authorizations. Requirements: Bachelor's in a scientific discipline, 12+ years in medical writing within pharma, CRO, or biotech, with extensive knowledge of drug development, clinical research, and regulatory guidelines. Preferred qualifications include a Master’s degree and experience leading global submission teams. High-value specifics: Focus on autoimmune disease therapies, with key assets including obexelimab (monoclonal antibody targeting B-cells) and orelabrutinib (CNS-penetrant BTK inhibitor). The role requires familiarity with regulatory documentation for marketing applications, GxP compliance, and clinical trial transparency. Stakeholder engagement includes close partnership with executive leadership, legal, finance, and external vendors. The position offers a hybrid work setup with quarterly travel to the headquarters, supporting a fast-paced, startup-like environment emphasizing innovation and collaboration.