Legal Counsel - Clinical R&D

Job Description

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.

Qualifications

• Qualification as a PRC lawyer or equivalent is a must.
• 7 or more years of legal experience in law firms or MNCs, with a background in pharma/life sciences clinical development is preferred.
• Working knowledge of U.S.-China regulatory frameworks (HGR Regulations, BIOSECURE Act, Bulk Data Transfer Rule, FCPA etc.)
• Experience with Chinese health authority engagement and the framework around drug development; familiarity with requirements for FDA approval of drugs developed in China is preferred.
• Demonstrate excellent legal analytical skills, with the ability to communicate complex issues clearly and concisely and to identify and address critical matters with speed and precision
• Proven ability to work across legal, business, regulatory, and operational teams
• Quick learner, able to rapidly pick up new legal and business domain knowledge, and able to gather and synthesize business context to provide practical, actionable legal advice
• Ability to work well independently and on a team and can prioritize multiple matters
• Professional proficiency in English, with strong written and verbal communication skills
• Mandarin language proficiency required

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html