1. Identify and develop clinical research strategies in China for Company products in assigned therapeutic areas e.g. gastroenterology including Pentasa, Elobixibat, Cortiment and new products in the pipeline.

2. Develop the content writing of clinical research related documents mainly including clinical trial protocol, Investigator’s Brochure, clinical study report and review statistical analysis plan, data management plan, etc to support clinical trial and meet local registration needs.

3. Provide scientific expertise to related study for product registration as needed.

4. Work as medical monitor in responsible studies, resolve scientific issues and ensure high quality together with study team.

5. Contribute to the preparation of the dossier and providing answers to the CDE (Centre for Drug Evaluation) in a timely fashion during any stage of clinical trial proceeding.

6. Ensure ICH-GCP, local regulatory and global policy compliance.

7. Ongoing review and develop SOPs as well as standard documentation tool kits applicable to clinical development in China.

8. Provide professional TA/product related trainings to clinical study team members and other related stakeholders. 9. Work as Local Safety Officer to ensure all studies in assigned therapeutic areas strictly follow company SOPs and applicable China laws/regulations.

Job Requirements:

1. Master or above degree with the major in clinical medicine, gastroenterology，Cardiovascular and Metabolic are preferred.

2. At least 1 years of pharmaceutical industry experience working as CRP or medical expert/scientist, familiar with clinical development strategy drafting, clinical study protocol writing, medical monitoring and CSR drafting according to ICH guidelines and company SOPs.

3. Good understanding of the overall drug development process, clinical trial methodology, China regulatory environment, ICH/GCP Guidelines and related FDA/EMA clinical development guidelines.

4. Fluent in both English and Chinese with good presentation skill.

5. Good communication and interpersonal skills - works well with others, motivates and encourages.

6. Demonstrated capability to deliver results under pressure with highly efficient/ elaborative characteristics.

7. Proficiency in Microsoft Outlook, Word, PowerPoint and Excel.

上班地址：科海大楼