Responsibilities：

A. Lead and oversee HGR activities throughout whole life cycle of the study specific

1. Startup Application Period

1) Pre-communication of application strategy/submission details/application form filling/submission internal and external process/timeline & HGR regulation request with stakeholders (incl. DSCN SM & TM/BM & CD Physician & CRO, etc).

2) Oversee and ensure all supporting documents both on electronic and original copy from SM & CRO & Vendor in a timely manner, etc.

3) Document check against regulations incl. format, completeness, correction, etc.

4) Communication & seek approval on application form submission from SM & other related function.

5) Collaborate and oversight CRO to submit the application form and upload docs to HGR website.

6) Updating & communication with SM on rejection/results of on-line submission.

7) Collaborate and oversight CRO to complete paper submission in a timely manner.

8) Work with SM & CRO to conduct data backup and prior reporting as applicable.

2. Ongoing Maintenance Period

1) Lead HGR amendment submission when applicable.

2) Monitor  data backup and prior reporting for external provision and open use is conducted as appropriate manner.

3) Lead monitoring of bio-sample type and actual amount versus approval.

4) Proactively work and communication with stakeholders for any question or consultation, address issues and concerns to respond regular updates, industry good practice, provide inputs and lead process optimization and issue resolution.

5) Routine check HGR documents per study to ensure accuracy and completeness in time.

6) Maintain HGR management system on data tracking and analysis.

3. Closeout period

1) Monitor final study summary submission completion.

2) Check and oversee all relevant HGR documents are completely and correctly recording on study folder.

B. Lead and liaise with relevant global and China functions to manage HGR affairs, monitor HGR implement compliance and portfolio reporting.

1. Maintain HGR submission and approval status tracker (incl. HGR Registration submission, HGR Exploratory submission, HGR amendment submission, & HGR account management), and conduct regular metrics and portfolio reporting to global and China related functions, to ensure accuracy, completeness and timeliness.

2. Serve as Subject Matter Expert (SME) in China of HGR management to develop and maintain the HGR manual, training materials and give education to global and China related functions.

3. Serve as DSCN point of contact to interact with HGRAC offices on policy and regulation update, as well as the main window of HGRAC connection to the industry and DS CRO partner.

4. Lead HGR inspection and internal auditing, coordinate with SM and related functions, compile and provide required information and data, and derive assigned activities to be completed.

5. Flat finding and issue and coordinate discussion with related function till resolution.

6. Maintain HGR related informatics system to ensure make the most of it and the data completeness and accurate.

7. Support bio-sample exportation in accordance with the relevant HGRAC and Customs procedures.

Qualification：

• Bachelor's degree in management, Pharmacy, Biomedical, Life Science, Public health, Chemistry, and biological science related. Advanced degree preferred.

• At least 2 years HGR related experience in the multinational pharmaceutical industry.

• Good understanding of HGR submission process according to the requirement by Ministry of Science and Technology (MOST).

• Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines.

• Good communication skill and presentation in both Chinese and English.

• Good interpersonal skills and ability to work in an international team environment.

• Willingness and ability to train others on study administration procedures.

• Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

• Integrity and high ethical standards

• Very good knowledge of spoken and written English.

• Computer proficiency of Word/Excel/PowerPoint.