职位名称：
RA Specialist
薪资:面议
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工作地点：天津市和平区
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所属部门：
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招聘人数：1
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工作性质：全职
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工作年限：不限
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学历：本科
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发布时间：2020-08-05 16:54:09
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浏览量 :0
职位描述：
Major Duties and Responsibilities
1、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、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 a timely manner；
3、Communicate and coordinate with internal departments, to ensure that the project is carried out on schedule;
4、Coordinate and follow-up on related work of registration in the international projects. Ensure the projects are carried out on schedule;
5、Comply with the internal rules and regulations. Be able to finish regular work in accordance with company；requirements, and be able to complete other work assigned by superiors and company.
Requirements
1、Master degree in medicine, pharmacy, biology, chemistry, etc；
2、Work experience in vaccine development, registration or clinical trials；
3、CET-6 or above；
4、Be able to access relevant literature references, draft and review reports and files independently;
5、With good communication skills, clear verbal and written expression and be good at active communication;
6、Be able to work independently, with strong collective awareness and good team spirit;
7、Acknowledge of vaccine production process and vaccine GMP regulations.