Project manager

Responsibilities:

1. Assist to complete the technical feasibility assessment in the project initiation research according to the company's project initiation requirements;

2. Assist the company to find and confirm the corresponding CRO company according to the project development needs;

3. Assist the company to sign a commissioned development agreement with the CRO, communicate with the CRO to confirm the research plan and implementation plan, follow up the CRO research and ensure that the research results meet the requirements;

4. Check and confirm the CRO development site, and review, collect and archive the research data; Assist the company to find the corresponding CMO company and sign the relevant agreement;

5. Assist relevant departments to audit the CMO and follow up the rectification of relevant production and inspection matching problems;

6. Organize and coordinate CRO or CMO to carry out sample sampling, on-site inspection, hair supplement research and other related work;

7. According to the overall research objectives of the project, formulate a technology transfer plan, and coordinate/organize the implementation of CRO and CMO according to the plan;

8. Review and confirm the project registration application materials, and assist in the project registration application; Collect and archive relevant documents in the process of technology transfer according to the requirements of registration and application;

9. Assist in completing pilot scale up, standard transfer, process verification, etc. according to the proposed transfer plan;

10. Assist in the formulation and review of relevant documents such as process procedures, batch records, etc. in the process of technology transfer;

Job requirements:

1. More than 5 years of experience in the development of (oral solid) preparations, and more than 2 years of experience in the position of department director (manager);

2. Familiar with drug R&D process, domestic and foreign drug R&D related laws and guidelines;

3. With project technology transfer experience, familiar with pilot test, validation and other prescription process amplification research;

4. Have more than 2 project (preparation) application data writing experience, and more than 1 project on-site verification experience;

5. Those with the above conditions and experience in drug project management are preferred.