Senior Director, Medical Writing

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide. Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven track record of success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development. Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts. As of January 2022, the Company has a global team of approximately 2000 employees. Primary Function: The Senior Director, Medical Writing leads the Medical Writing function at Zai Lab, managing a team of medical writers based in the US and China. Reporting to Chief Operating Officer R&D, this is a hands-on role that combines people leadership with direct authorship and oversight of clinical and regulatory documents across all phases of drug development, from IND through NDA/BLA/MAA submissions. This role is accountable for building team capability, establishing consistent standards and processes, and ensuring the on-time delivery of high-quality documents across Zai's global pipeline. Major Responsibilities and Duties: Team Leadership: Lead and manage the Medical Writing function, including a team of medical writers based in the US and China, providing day-to-day direction, workload planning, and career development; recruit, onboard, and develop medical writing talent, and conduct performance reviews for team members across the US and China. Hands-On Authorship: Personally, author and finalize clinical and regulatory documents across all phases of drug development, including protocols, investigator's brochures, clinical study reports, patient safety narratives, briefing documents, and IND/NDA/BLA/MAA submission components, maintaining a hands-on writing caseload alongside team leadership responsibilities. Standards & Process: Establish and continuously refine SOPs, templates, and style guides to drive consistency, quality, and efficiency across the writing function. Regulatory & Quality Compliance: Stay current on evolving regulatory guidelines and industry best practices, ensuring all documents meet applicable regulatory, scientific, and quality standards. Resourcing: Own resourcing and workload planning across the team, including decisions on the use of contract writers and vendors to support peak demand. Cross-Functional Partnership: Partner with Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs leadership to align medical writing support with program timelines and strategy. Document Oversight: Lead document roundtables, cross-functional reviews, and issue resolution to ensure documents meet scientific, regulatory, and quality standards ahead of key milestones. Scientific Communications: Contribute to the planning and development of scientific publications, congress materials, and related communications as needed to support assigned programs. Strategic Representation: Represent medical writing in cross-functional and regulatory strategy discussions, ensuring alignment across global teams and regions (US, China). Global Collaboration: Collaborate across time zones (US and China) and travel up to 20%. REQUIRED: · BS/BA in a relevant scientific discipline with 15 years of experience in medical / regulatory writing within the biopharmaceutical industry; or equivalent combination of higher education, training and experience. PREFERRED: Advanced degree (PhD, PharmD, MD). Proven track record building, leading, and developing a high-performing medical writing team, including direct line management experience. Extensive experience preparing documents supporting global regulatory submissions, with direct experience interfacing with regulatory agencies in more than one key region (e.g., US, EU, China). Experience managing or building a small, distributed medical writing team spanning the US and China, or a similarly matrixed global organization. Therapeutic area expertise in oncology; familiarity with immunology or anti-infective therapeutic areas is a plus. Outstanding leadership, collaboration, and communication skills; comfortable operating as a hands-on leader in a fast-paced, cross-functional environment. Knowledge of eCTD content/format requirements and experience authoring in ICH-compliant templates proficient in Microsoft Word, Excel, and PowerPoint, with experience using Adobe Acrobat. Experience in biotech and cross-regional collaboration with Asia/China. Must have the highest personal values and ethical standards. The pay range for this position at commencement of employment is expected to be between $258K and $361K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Zai Lab, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 59% of our employees are women and 53% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life,” is integrated within our business. Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. 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