Manager/Senior Manager

Job responsibilities:

1. Responsible for writing various clinical research documents submitted to the RA department, including but not limited to:Clinical protocols, Clinical research reports, IB, DSUR, NDA materials, etc；

2. Responsible for the establishment，development and maintenance of clinical research plans, clinical research reports and other relevant medical document writing templates；

3. Responsible for establishing and updating the SOP for writing related medical documents；

4. Responsible for establishing, updating and maintaining various writing tool forms within the department；

5. Write with relevant functional departments such as medicine and statistics, actively participate in clinical research conferences, and accurately interpret and express clinical research results；

6. Perform quality control on various medical documents in accordance with relevant SOP requirements；

7. In-depth study of the requirements of domestic and international drug regulatory authorities on the content and format of medical reports, establish relevant templates, and maintain and update them in a timely manner；

8. Cooperate with relevant departments to establish an SOP for collaborative medical documents, and update and adjust them according to the actual situation；

9. Establish good communication and cooperation with internal and external customers to ensure the smooth progress of the project.

Job requirements:

1. Educational requirements: Master or above in medicine or pharmacy；

2. Work experience: at least 2 years of relevant medical writer work；

3. Ability requirements: excellent Chinese and English writing skills and clear oral expression skills, independent working ability, strong team spirit, good problem solving skills and emergency plan management skills, attention to details, and patience at work；

4. Skill requirements: Familiar with drug management law, drug registration management methods, ICH-GCP, English proficiency level CET6, and master the application of office automation software.

E-mail：hr@simrbio.com