Global Medical Writing Director: Lead & Write Submissions

Zai-Lab-; South San Francisco (CA); Hybrid; USD 258.000 - 361.000; Vollzeit

Benefits dieser Stelle

401(k) eligibility

Paid time off

Health benefits

Zusammenfassung

Zai Lab seeks a Senior Director, Medical Writing to lead a global function based in the US and China. The role combines people leadership with hands-on authorship across IND through NDA/BLA/MAA submissions, ensuring on-time delivery of high-quality documents for the company's pipeline.

You will build capability, set standards, manage resourcing and collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs to align timelines and strategy across regions (US and

Qualifikationen

• 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.
• PhD/PharmD/MD preferred.
• Experience preparing documents for global regulatory submissions and interfacing with regulatory agencies in multiple regions (US, EU, China).
• Experience leading a distributed medical writing team across US and China.

Aufgaben

• Lead and manage the Medical Writing function with US/China writers, directing workload and career development.
• Personally author and finalize clinical/regulatory documents across all phases of drug development.
• Establish SOPs, templates and style guides to drive consistency and quality.
• Ensure documents meet regulatory, scientific and quality standards.
• Plan resources and decide on contract writers/vendors to support peak demand.
• Partner with Clinical Dev, Regulatory Affairs, Biostatistics, and Medical Affairs to align timelines.
• Lead document rounds and cross-functional reviews to meet milestones.
• Contribute to publications planning and congress materials as needed.
• Represent medical writing in regulatory strategy discussions across regions.
• Collaborate across time zones US/China and travel up to 20%.

Kenntnisse

Team Leadership

Hands-On Writing

SOPs & Standards

Regulatory Knowledge

Resourcing

Cross-Functional

Scientific Communications

Ausbildung

BS/BA in science

PhD/MD preferred

Tools

eCTD knowledge

MS Word

Excel

PowerPoint

Adobe Acrobat

Jobbeschreibung

Zai Lab seeks a Senior Director, Medical Writing to lead a global function based in the US and China. The role combines people leadership with hands-on authorship across IND through NDA/BLA/MAA submissions, ensuring on-time delivery of high-quality documents for the company's pipeline.

You will build capability, set standards, manage resourcing and collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs to align timelines and strategy across regions (US and