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About the Role

The Senior Director, Medical Writing leads the Medical Writing function, managing a team of medical writers in the US and China. This hands-on role involves people leadership and direct authorship/oversight of clinical and regulatory documents across all phases of drug development. The role is accountable for building team capability, establishing standards and processes, and ensuring timely delivery of high-quality documents for Zai's global pipeline.

Responsibilities

• 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.
• 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.
• Establish and continuously refine SOPs, templates, and style guides to drive consistency, quality, and efficiency across the writing function.
• Stay current on evolving regulatory guidelines and industry best practices, ensuring all documents meet applicable regulatory, scientific, and quality standards.
• Own resourcing and workload planning across the team, including decisions on the use of contract writers and vendors to support peak demand.
• Partner with Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs leadership to align medical writing support with program timelines and strategy.
• Lead document roundtables, cross-functional reviews, and issue resolution to ensure documents meet scientific, regulatory, and quality standards ahead of key milestones.
• Contribute to the planning and development of scientific publications, congress materials, and related communications as needed to support assigned programs.
• Represent medical writing in cross-functional and regulatory strategy discussions, ensuring alignment across global teams and regions (US, China).
• Collaborate across time zones (US and China) and travel up to 20%.

Requirements

• 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.
• 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.

Skills

• Medical Writing
• Regulatory Writing
• Team Leadership
• People Management
• Clinical Document Authoring
• Regulatory Document Authoring
• SOP Development
• Process Improvement
• Regulatory Compliance
• Cross-Functional Collaboration
• Scientific Communication
• Global Collaboration
• eCTD
• ICH Guidelines
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Adobe Acrobat

Location

• US
• China

Work Type

• Full-time

Experience Level

• Senior Director
• 15 years of experience

Education Level

• BS/BA
• Advanced degree (PhD, PharmD, MD) - Preferred

Salary/Compensations

• $258K - $361K/year

Benefits

• Sign-on bonus
• Restricted stock units
• Discretionary awards
• Full range of medical benefits
• Full range of financial benefits
• 401(k) eligibility
• Various paid time off benefits (vacation, sick time, parental leave)

About the Company

• Zai Lab Limited is an innovative, research-based, commercial-stage biopharmaceutical company focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and globally.
• Founded in 2014, Zai Lab has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates.
• Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to access the Chinese market and find a long-term strategic partner for global clinical development.
• The company's unique business model builds on in-licensed assets and innovative partnerships to expand internal discovery and development capabilities, creating a portfolio of potential best-in-class and/or first-in-class therapies.
• Zai Lab has four products on the market in China.
• Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed a secondary listing on the Hong Kong Stock Exchange in September 2020, becoming dual-primary listed on both exchanges in 2022.
• Zai Lab has expanded significantly with several offices across China and established its U.S. Headquarters in Cambridge, Massachusetts in 2021.
• As of January 2022, the Company has a global team of approximately 2000 employees.

Equal Opportunity

• 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.
• Zai Lab is 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.