南湖人才网_南湖招聘网_求职找工作平台

工作職責:主要職責 Major Duties and Responsibilities1. 按照公司海外項目注冊策略與藥監部門的要求，進行申報資料的撰寫、翻譯和提交，保證申報資料的準確性與可靠性；Be responsible for writing, translation and submission of the application documentations in accordance with international registration strategy and the requirement of regulatory agency.Guarantee the accuracy and reliability of the application documentations.2. 按照程序及時申報，并配合藥品監管部門或 CRO 公司辦理相關手續，保證申報工作按時完成. Submit the applications according to the procedures. Cooperate with the regulatory agencies or CRO companies to handle relevant procedures. Guarantee to complete the applications in timely manner.3.與外部合作單位溝通協調，確保項目按期開展；Communicate and coordinate with external cooperation companies, to ensure that the project is carried out on schedule;3.協調和跟進國際項目中和產品注冊相關的工作，保證項目按期開展；Coordinate and follow-up on related work of registration in the international projects. Ensure the projects are carried out on schedule;4. 負責聯絡、跟進國際臨床試驗各參與方，保證溝通交流準確、順暢，并按期整理項目進展，保證項目按期開展；Communicate with the partners or subcontractors in international clinical trials, to provide active communication and summarize the project progress regularly. Ensure the projects are carried out on schedule;5. 遵守公司規章制度，按照公司要求完成部門工作，并完成上級和公司交辦的其他內容工作。Comply with the internal rules and regulations. Be able to finish work in accordance with company requirements, and be able to complete other work assigned by superiors and company.任職資格:1. 碩士學歷，醫學、藥學、生物學、化學等相關專業，有海外留學背景優先。Master degree and major background in medicine, pharmacy, biology, chemistry, etc. Experience of study abroad is preferred.2. 具有***研發，或注冊申報、臨床試驗開展相關工作經驗三年。Three years’ work experience in vaccine development, registration or clinical trials3. CET-6 and above4. 能獨立查閱有關英文文獻資料，撰寫和審核各類英文材料與報告；Be able to access relevant literature references in English, draft and review reports and files in English independently; 5. 具有良好的溝通交流能力，清晰的口頭和書面表達能力，善于進行積極活躍的溝通；With good communication skills, clear verbal and written expression and be good at active communication;6. 具有獨立工作的能力，并同時具有較強集體意識和良好的團隊合作精神；Be able to work independently, with strong collective awareness and good team spirit;7.了解***生產過程，熟悉*** GMP 法規。Acknowledge of vaccine production process and vaccine GMP regulations. 職能類別：藥品注冊