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01-24 发布
- 五险一金
- 补充医疗保险
- 员工旅游
- 交通补贴
- 餐饮补贴
- 通讯补贴
- 专业培训
- 绩效奖金
- 定期体检
职位描述
Job Description:I.PK/BE/CT strategy?Draft the PK/BE/CT strategy based on Clinical use and the requirements by CFDA regulatory.?Identify and confirm RLD and testing samples available, and procure RLD in China or import it by one-time IDL.?Collaborate with India team for CRO and Hospital Site auditing.II.CRO and Site identification and protocol finalization?Identification of CRO’s for conducting the PK/BE/CT in china.?Coordinate with different CROs/Hospital /Bioanalytical sites to facilitate the protocol finalization process.?Collaborate with India team for shipment of Investigational products for conducting PK/BE/CT at CRO/Hospital Site.?Project management of biostudies: e.g. Support in providing documents like EC submissions, OHGRA approval, Import license, e.t.c.III.PK/BE/CT following up?Onsite monitoring of PK/BE/CT at Hospital sites.?Follow up and get updates for the ongoing PK/BE/CT at CRO’s.?Collaborate and work closely with different stake holders in India and China RO office for seamless execution of Biostudies.?Facilitate Study closeout activities at CRO/Hospital sites.IV.Finalization of PK/BE/CT report for filing?Facilitate finalization of pivotal PK/BE/CT -reports as per Chinese regulations and assist submission for regulatory filing.V.Assist and company CFDA auditing to Hospital Site?Schedule, assist and company CFDA auditing Hospital Site based on CFDA timeline.?To provide support in addressing bio-deficiencies received from CFDA. 职能类别： 临床研究员
联系方式
光华路东方梅地亚中心
公司信息
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY), herein referred to as Dr. Reddy’s, is an integrated global pharmaceutical company established in 1984, which is committed to providing affordable and innovative medicines for healthier lives. Through its three business-Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products, Dr. Reddy’s offers a portfolio of products and services including Active Pharmaceutical Ingredients (APIs), Custom Pharmaceutical Services (CPS), generics, bio-similars, differentiated formulations and News Chemical Entities (NCEs). The company enjoys a strong presence in the U.S., U.K., Germany, Russia and CIS, Romania, Venezuela, China, South Africa and New Zealand. Dr. Reddy’s corporate offices are located in Hyderabad, India. The total revenue of Dr. Reddy’s was USD $2.20 Billion as on 31st March, 2014. For more information, pls visit www.drreddys.comIn China, Dr. Reddy’s Laboratories Ltd. operates through its joint venture with Rotam Group of Canada. The joint venture is widely known as Kunshan Rotam Reddy Pharmaceutical Company Ltd. (KRRP) with a local manufacturing facility located in Kunshan, Jiangsu Province. KRRP was established in year 2000 complying with China laws with a total investment of USD29.99 million.
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