上海招聘

Job description
1.According to the drug registration program to edit the corresponding registration information;
2.To organize and track the declaration and registration of clinical progress of drug registration, timely access to relevant information, provide professional support to the registered items;
3.Analysis of different national register data requirements on the drug, to provide professional advice for the registered project;
4.Responsible for the management of affairs specialist with the Commissioner and other personnel work;
5.Develop and maintain the drug registration and local government relations;
6.Review and track registration project progress.
Post requirements
1.The registration of more than 2 years experience in pharmaceutical or CRO field;
2.Rrich in multi center clinical trials or drug import registration experience;
3.The medicine or related major, university education background is preferred,;
4.Certified project management ability, good effective problem solving and organization plan;
5.Capacity has audit declaration data, and the drug development and approval process, the registration regulations have a comprehensive understanding and grasp;
6.Good coordination and communication skills, excellent team experience, and can provide good training for staff in the team;
7.University English level 4 or above, fluent oral English is preferred;

  Beijing Health Tech Medical Group (HT-Med) was founded since 2004. We are a comprehensive medical Operation and development organization .Assemble excellent talents of medicine, pharmacy, data management and statistical fields, offering professional services to support biotech and pharmaceutical companies at every stage of product lifecycle .
 
 We provide Medical translation, Data Management, Statistical Analysis, Medical Writing, Regulatory Affairs, Project Evaluation and Management, Independent Audit, Training, CRA/CRC/DM dispatch. Since we established, we were developing new drugs with Chinese Academy of Medical Sciences, Peking University Health Science Center, The General Hospital of the PLA, Military Medical Sciences, etc. Has cooperated with over 90% clinical trial sites (hospital) approved by SFDA.

  We developed independently EDC+CTMS by ourselves, obtained 3 patents and 2 brands. Basing on excellent IT capability, we develop Products Data Center for our clients, and created role exchange pattern between CRA and CRC, improved speed&quality of Clinical Study by the model of EDC+CRC, especially in PMS. We have been became the vendor of lots of global company (AZ, GSK, BI, Abbott, Roch, Mundipharma, QPS etc.) and some official Institution (Chinese Academy of Medical Sciences, Peking university, The general hospital of Chinese PLA, Sanming hospital, Zhejiang oncology hospital, Academy of Military Medical Sciences of the Chinese PLA etc.).

 We are familiar with China SFDA policy and CDE mentality, possessing mass of expert resource and marketing support. we could cover 90% Chinese certificated clinical research hospital by lots of home-based employee in 18 cities.

  公司网址：http://www.ht-med.com