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工作職責(zé):主要職責(zé) Major Duties and Responsibilities1. 按照公司海外項(xiàng)目注冊策略與藥監(jiān)部門的要求，進(jìn)行申報(bào)資料的撰寫、翻譯和提交，保證申報(bào)資料的準(zhǔn)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(shí)申報(bào)，并配合藥品監(jiān)管部門或 CRO 公司辦理相關(guān)手續(xù)，保證申報(bào)工作按時(shí)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(xié)調(diào)，確保項(xiàng)目按期開展；Communicate and coordinate with external cooperation companies, to ensure that the project is carried out on schedule;3.協(xié)調(diào)和跟進(jìn)國際項(xiàng)目中和產(chǎn)品注冊相關(guān)的工作，保證項(xiàng)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(fù)責(zé)聯(lián)絡(luò)、跟進(jìn)國際臨床試驗(yàn)各參與方，保證溝通交流準(zhǔn)確、順暢，并按期整理項(xiàng)目進(jìn)展，保證項(xiàng)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(guī)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(nèi)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(xué)歷，醫(yī)學(xué)、藥學(xué)、生物學(xué)、化學(xué)等相關(guān)專業(yè)，有海外留學(xué)背景優(yōu)先。Master degree and major background in medicine, pharmacy, biology, chemistry, etc. Experience of study abroad is preferred.2. 具有***研發(fā)，或注冊申報(bào)、臨床試驗(yàn)開展相關(guān)工作經(jīng)驗(yàn)三年。Three years’ work experience in vaccine development, registration or clinical trials3. CET-6 and above4. 能獨(dú)立查閱有關(guān)英文文獻(xiàn)資料，撰寫和審核各類英文材料與報(bào)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(dá)能力，善于進(jìn)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(dú)立工作的能力，并同時(shí)具有較強(qiáng)集體意識和良好的團(tuán)隊(duì)合作精神；Be able to work independently, with strong collective awareness and good team spirit;7.了解***生產(chǎn)過程，熟悉*** GMP 法規(guī)。Acknowledge of vaccine production process and vaccine GMP regulations. 職能類別：藥品注冊