POSITION RESPONSIBILITIES

In order of importance, list the primary responsibilities critical to the performance of the position. It is recommended not to list actual tasks but focus on essential responsibilities that highlight accountability and level of judgment required. ·

Legal support for various issues in connection with clinical studies and regulatory activities, such as:

？ Advise on legal issues in connection with clinical trials, including adverse events, drug importation, trial quality issues, self-assessments and government inspections, sample collection and export, post study drug access, article publication, audits, etc.; and

？ Review agreements and templates, informed consents, recruitment materials, etc.. ·

Interact with government authorities and hospitals on issues such as:

？ Regulatory affairs;

？ Research injury legal proceedings;

？ Drug and human sample exportation/importation and testing;

？ Inspections and self-assessments;

？ Contract negotiation; etc. ·

Report on regulatory updates:

？ Review and comment on updated regulations on a regular and as needed basis;

？ Assess and summarize local regulatory changes for global and regional awareness;

？ Collaborate with industry and academic associations regarding legislative activities. ·

General legal support to various functions of Shanghai R&D site, as needed - for example:

？ Handle lease matters

？ HR issues

？ Review of public presentations, newsletters, etc

？ Maintain copies and information regarding company’s business registration; and handle registration changes

The Legal Counsel is expected to: ·

exercise professional judgement ;

prioritize and manage multiple assignments;

be able to respond to internal and external clients in a timely and efficient manner;

collaborate with various parties and lead the discussion or negotiation as needed;

attend conference calls across different time zones;

have strong organizational, interpersonal and communication skills in Mandarin and English.

REQUIREMENTS

Indicate the formal education, certification or license required and/or preferred.

Include the minimum number of years of relevant experience required for the position (where legally permissible).

Indicate technical skills, any physical requirements and necessary competencies.

Graduate of a law program from an accredited university in or outside China, with a certification from the China Bar (or other relevant bar association)

At least 5 years of post-qualification experience in law

At least 2 years’ experience in the pharmaceutical industry or handling pharma company matters in a law firm

上班地址：张江高科