Senior Director, Medical Writing

Role: Senior Director of Medical Writing at Zai Lab, leading global medical writing activities for clinical and regulatory documents across all drug development phases. Objectives include building and managing a high-performing team in the US and China, ensuring high-quality, compliant documentation, and supporting global regulatory submissions. Responsibilities encompass team leadership and development, authorship of core documents (protocols, CSRs, IND/NDA/BLA/MAA components), establishing standards and processes, regulatory compliance, resource planning, and cross-functional collaboration with Clinical Development, Regulatory, Biostatistics, and Medical Affairs. The role involves hands-on writing, oversight of document quality, and strategic input on scientific communications and regulatory strategies, with up to 20% travel. Qualifications: BS/BA in a scientific discipline with 15+ years in medical/regulatory writing in biopharma; advanced degrees (PhD, PharmD, MD) preferred. Experience in preparing global regulatory documents, regulatory agency interactions (US, China, EU), and managing distributed teams is required. Therapeutic expertise in oncology, immunology, or anti-infectives is advantageous. Skills include proficiency in ICH and eCTD standards, Microsoft Office, Adobe Acrobat, and cross-regional collaboration. The position is based in a hybrid setting, supporting a pipeline with high regulatory complexity, spanning IND through NDA/BLA submissions.