Senior Director, Medical Writing

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 Zais 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 investigators 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%.

Qualifications :

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.

Additional Information :

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. Thats 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.

Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context.  Privacy Notice available upon request.

Remote Work :

No

Employment Type :

Full-time