Jobs_Heze Keteng Biotechnology Co., Ltd

Technical R&D Manager

Education：Master's degree or above
Experience：Over 3 years
Recruitment unit：Heze Keteng Biotechnology Co., Ltd
Date：2023-06-27
Working place：heze
Recruitment number：1人
Salary：Interview

Job requirements

Job responsibilities: 1. Responsible for interpreting clinical and statistical policies, regulations, and guiding principles related to drug registration in China, and providing registration support. 1.1 Timely follow up on the search and sharing of drug registration regulations and guiding principles, and interpret them according to project needs; 1.2 Participate in clinical medicine and statistics related project meetings, analyze key technical indicators from a registration perspective, and provide suggestions; 2. Responsible for reviewing and integrating domestic drug registration application materials, as well as writing some materials, to meet the requirements of registration regulations for application materials. 3. Provide literature research and data support for new projects to provide a basis for project initiation. 4. Assist and support on-site verification of drug registration. Job requirements: 1. Master's degree or above, major in medicine, pharmacy, or related fields. 2. More than 5 years of work experience in drug registration, with rich experience in applying for clinical drug approval (IND), proficient in GCP, ICH-GCP, drug registration regulations, and clinical research processes. 3. Good Chinese and English Document retrieval and medical information retrieval ability and reading ability. 4. Strong execution and planning skills, coordination and communication skills, sense of responsibility and pressure resistance, as well as problem analysis and resolution skills.
Email for submitting resumes:: sales@hzktbio.com

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