The Legal Counsel, Clinical R&D, China, will be responsible for providing dedicated legal support for AbbVie's growing R&D activities in China, including advising on key legal and regulatory requirements such as related Chinese laws and regulations including the Drug Administration Laws and regulations, Human Genetic Resource Regulations, and GCP, the U.S. BIOSECURE Act, and the Bulk Data Transfer Rule etc. The responsibilities of the Legal Counsel, Clinical R&D, China, will include:
- Serving as a recognized source on Chinese regulations governing AbbVie's pipeline and drug development, with working knowledge of the U.S. BIOSECURE Act, Bulk Data Transfer Rule, and related U.S. legal frameworks.
- Advising, developing and clearly communicating legal guidance on clinical research in China, including Chinese and US law and regulatory requirements covering patient privacy and rights, data integrity, site and investigator non-compliance, bioethics, fraud and abuse matters, and digital health.
- Providing end-to-end R&D legal support for assigned TA(s) — from early development and clinical trial design through regulatory filing and pre-commercialization.
- Acting as a business partner for the assigned R&D functions in China
- Collaborating with legal cross-functions (legal teams covering IP, transaction, privacy, commercial, alliance etc.) and R&D stakeholders to empower AbbVie's growing R&D activities in China.
- Counselling on health authority engagement to accelerate drug development
- Drafting agreement templates and reviewing a broad range of agreements, including clinical study agreements, collaborative research agreements, service provider agreements supporting clinical trial operations, and other complex R&D and transactional agreements with research partners, while developing reusable legal solutions for recurring business needs
- Developing and advising on patient informed consent forms for clinical research, incorporating feedback from regulatory authorities and ethics committees, and consolidating recurring issues into practical legal guidance.
- Tracking regulatory developments and advising internal stakeholders on how changes in U.S.-China policy affect current and prospective collaborations and impact R&D strategies
- Build and/or support guidance and training on key U.S.-China regulatory requirements.