Zai Lab (NSDAQ: ZLAB) is an innovative, research-based, commercial stage biopharmaceutical company based in China and the U.S. focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world.
Headquartered in Shanghai since our founding in 2014, our experienced team has secured partnerships with leading global biopharma companies, generating a broad and late-stage pipeline of innovative drug candidates.
Based on our extensive track record of execution and delivering results, 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.
Through these partnerships, Zai Lab has built the strongest late stage oncology portfolio with global first-in-class and/or best-in-class profile, among innovative Chinese biotech companies. We are further supplementing our pipeline with an in-house discovery effort aiming to produce 1-2 global INDs per year.
Zai Lab is rapidly expanding into a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing innovative medicines. To that end, we have built our internal R&D center to advance our discovery pipeline, a strong clinical development and operations team, and our own manufacturing facilities in China. We have also established a highly specialized commercial team to support marketing of our innovative products in China. We believe this integrated approach will provide sustainable competitive advantages for Zai Lab.
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. Zai Lab significantly expanded with several offices across China and U.S. and opened its U.S. headquarters in San Francisco in December 2018. As of June 2021, the Company has a global team of over 1600 employees.
The Senior Director, Medical Writing at Zai Lab will be responsible for oversight of clinical and regulatory writing activities in the US/EU. Reporting to Head of Medical Writing & Medical Science, the Director/Senior Director, Medical Writing oversees and manages the preparation of clinical trial level and regulatory submission level clinical and regulatory documents in scope of medical writing in the US, in compliance with all applicable laws and regulations.
This role is essential to Zai’s growing pipeline in the US and internationally. Both hands-on writing and managerial responsibilities are expected of this role.
- Working with the Head of MW&MS, build, manage, and lead the US Medical Writing team to support global cross functional teams with clinical/regulatory document generation.
- Work with the Head of MW&MS to continuously improve the quality and efficiency of the medical writing group by training, optimizing and implementing SOPs/working instructions/templates, and improving project/time management and team communications skills.
- Work closely with relevant project team members and function leads to develop resourcing strategies and implement new best practices in clinical/regulatory documents development, and train and develop less experienced writers within the group.
- Collaborate with key project team stakeholders and in-house and contract medical writers, plan and prepare clinical and regulatory documents necessary for all phases of drug development by organizing, analyzing, interpreting, and reporting clinical and statistical data. Such documents include but are not limited to clinical study protocols, investigator’s brochures, clinical study reports, patient safety narratives, briefing documents, IND and NDA/BLA/MAA clinical summary and overview sections, and regulatory query responses.
- Coordinate and lead document roundtables, reviews, approvals, quality control and other document content/format issues and overall questions during documents authoring process.
- Resource planning for the US medical writing team.
- Provide substantive advice on strategy, regulations and industry best practices to cross-functional teams.
- Participate in team meetings to assure cross-functional coordination and alignment to regulatory strategies.
- Create procedures that drive consistency in processes and deliverables.
- Review and update style guide to ensure consistency across documents.
- Other responsibilities as assigned.
- Minimum BS/BA in life sciences. Advanced degree preferred
- At least 10 years (at least 15 years for the Senior Director position) of experience in writing clinical regulatory documents; writing expertise preferably includes the oncology therapeutic areas; familiarity with the immunology and anti-infective TAs is a plus
- Experience and knowledge in the preparation of documents supporting US/EU regulatory submissions
- Ability to understand and interpret clinical and scientific data
- Knowledge and understanding of applicable US and global regulations and guidance
- Strong organizational skills
- Excellent verbal and written communication skills
- Strong interpersonal skills and the ability to work effectively with a variety of personnel including contract medical writers; ability to influence to create positive outcomes
- Experiences in developing processes and standards to ensure high quality and compliance of clinical documents
- Knowledge of eCTD content/format requirements
- Familiar with document authoring in ICH-compliant templates
- Skilled in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat
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.