Job Responsibilities:

1. Be responsible for the formulation, writing and revision of medical-related materials for clinical research projects, including clinical research protocols, ICFs, IBs, etc. 

2. Assist in the writing and response of IND materials both domestically and internationally, and when necessary, assist the registration department in communicating with the drug regulatory authorities. 

3. Be responsible for medical data review or medical monitoring in clinical trial projects, such as inclusion and exclusion criteria review, protocol deviation review, AE/SAE review, writing of SUSAR reports and other technical support work. 

4. Coordinate and communicate with the principal investigator, clinical research centers, biostatistics, etc., and handle medical issues related to the project. 

5. Assist in the writing and updating of medical-related SOPs. 

6. Analyze test data, collect and organize clinical trial reports, and interpret industry report data. 

7. Participate in and support the formulation and implementation of research and development strategies in relevant disease areas. 

8. Participate in clinical project kick-off meetings, protocol discussion meetings, investigator meetings, etc., and provide medical support. 

9. Other tasks assigned by the leader. 

Qualifications:

1. Master's degree or above in clinical medicine, clinical pharmacy or related fields from a full-time program.

2. At least 1 year of relevant work experience in clinical medicine. Candidates with experience in cell therapy projects or as clinical doctors will be given priority. 

3. Be familiar with the entire process of clinical research and Good Clinical Practice (GCP). 

4. Be able to adapt to business trips, be highly responsible, work carefully and meticulously, and have a sense of teamwork.