1. Responsible for quality monitoring and management of clinical research projects, ensuring that trial projects strictly follow protocols, SOPs, and relevant regulations, and properly establish and manage project documents;

2. Lead and manage phase I or BE clinical trials and related matters, including center screening, project initiation, subject recruitment, data collection, drug management, data management, and reporting;

3. Responsible for communicating and coordinating with data management, biostatistics, and medical affairs, and completing data management plans/reports, statistical analysis plans/reports, Q&A, data review meetings, summary meetings, and summary reports as planned;

4. Participate in the writing and review of research plans, research plans, research reports, researcher manuals, and related materials;

5. Communicate promptly with CRO or superiors to conduct center screening and evaluation, supplier selection, etc; As the main contact person for suppliers, participate in selecting suppliers and continuously track and evaluate quality and compliance; Collaborate with internal colleagues and suppliers, proactively identify risks in clinical trials, develop avoidance plans, and notify relevant personnel to ensure that clinical trials are completed within the budget and planned time frame for enrollment and other tasks;

6. Ethical declaration, BE filing, human heritage declaration, contract signing, and communication and coordination with clinical pharmacology institutions;

7. Responsible for reviewing, analyzing, and interpreting clinical research results and statistical reports;

8. Responsible for timely reporting and assisting in handling various adverse events that occur in clinical trials, confirming that all adverse events are recorded, and reporting and recording serious adverse events within the specified time frame;

9. Assist the superior in completing project management work for clinical trials.

1. Have 5 years or more of clinical supervision work experience, have participated in the entire trial process and links, and have at least 2 years of clinical project management experience;

2. Bachelor's degree or above, clinical medicine is preferred;

3. Familiar with the Drug Administration Law, ICH-GCP, the entire process of drug research and development, proficient in clinical trials, and familiar with the development and current status of clinical research at home and abroad;

4. Strong leadership and execution skills;

5. Fully grasp the knowledge of clinical trial management standards, and be able to carry out relevant training and quality control;

6. Able to independently access relevant literature and write various reports;

7. Have excellent problem-solving and emergency plan management skills;

8. Good communication, organization and coordination ability, team spirit and strong analytical ability;

9. Fluent in English reading and writing, able to work in an English working environment.

1. Responsible for the overall registration of imported and domestic raw materials;

2. Responsible for coordinating and obtaining relevant registration materials from foreign companies and relevant departments of the company, while ensuring the completeness and accuracy of the registration materials;

3. Responsible for applying for registration of changes related to raw materials;

4. Responsible for submitting registration materials to the drug regulatory department and tracking the approval progress to ensure timely approval.

1. Bachelor's degree or above, major in chemistry or pharmacy;

2. Eight years of relevant work experience, with strong English communication skills (especially written communication skills);

3. Good interpersonal communication skills and teamwork ability;

4. Familiar with the operation of office software such as Word, Excel, PowerPoint, etc.

1. Microbial testing of raw and auxiliary materials and packaging materials;

2. Microbial testing of finished products and stability samples;

3. Microbial testing of cleaning validation samples;

4. Clean area environment, clean workbench, personnel hygiene, and compressed air system testing;

5. Inspection of the suitability of the culture medium, suitability testing of microbial methods, equipment confirmation, strain propagation, and other related work;

6. Drafting of SOP and Method Applicability Test Plan and Report

7. Other tasks assigned by the supervisor.

College degree or above, major in Microbiology, Biotechnology (Engineering) or related fields,

Having a theoretical foundation in microbiology and familiar with the basic operations of microbiological testing

Possess good Excel/WORD and instrument software application skills

Organized and proactive in work, with good practical skills

CET-4 is preferred.

1. Daily analysis of raw materials and preparations;

2. Stability inspection of raw materials and preparations;

3. Research and validation of new analytical methods;

4. Translation and organization of pharmaceutical research materials for imported drug registration;

5. Compliance work with laboratory regulations, such as standardization of standard products and instrument verification;

1. Bachelor's degree in pharmacy, chemistry, pharmacy, and related majors,

2. At least two years of relevant experience in analysis.