Senior Director, Medical Writing

Role: Senior Director of Medical Writing at Zai Lab, leading a global team managing clinical and regulatory documentation across all drug development phases. Objectives: ensure high-quality, compliant documents supporting IND to NDA/BLA/MAA submissions, establish standards, and deliver on pipeline milestones. Responsibilities: manage US and China-based writers, author key documents such as protocols and study reports, develop SOPs, maintain regulatory compliance, plan resourcing including vendors, and collaborate cross-functionally with Clinical Development, Regulatory, and Medical Affairs. Qualifications: BS/BA in a scientific discipline with 15+ years in biopharma medical/regulatory writing; advanced degrees (PhD, PharmD, MD) preferred. Experience in global regulatory submissions, team leadership, and working across regions, especially US and China, is required. Therapeutic focus areas include oncology, with familiarity in immunology or infectious diseases a plus. Technical skills include proficiency in ICH eCTD standards, Microsoft Office, and Adobe Acrobat. The role involves strategic and hands-on contributions, with up to 20% travel, and reports to the COO of R&D.