Responsibility：

China has implemented the new Human Genetic Resource (HGR) regulation in July, 2019. In response to the changes/updates in HGR regulation, DD CR has established a comprehensive HGR management to ensure compliance. The incumbent will play a role as HGR expert and point of contact to lead HGR related activities in China, to drive HGR process and support China Study Manager to achieve HGR approval within aligned timelines from Clinical Study Protocol (CSP) finalized, to maintain HGR tracking for all studies including documents, coordination (internally & externally), submission, process and training, communication and monitoring.

Requirement：

1. Bachelor degree in Management, Pharmacy, Biomedical, Life Science, Public health, Chemistry, and biological science related. Advanced degree preferred.

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

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

4. 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.

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

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

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

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

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

10. Integrity and high ethical standards

11. Very good knowledge of spoken and written English.