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各位大侠大家好... 我们是TTC猎头公司，专业为global药厂/CRO搜寻优秀人才。 目前我们为一家欧洲药厂觅妇产科/消化科博士研究生（应届，在职均可），工作地点在北京。 职位主要涉及clinical operation， strategy等等 有意者可将简历直接发送到我邮箱，或电话与我联系。 基本要求： 1.Ph.D. degree in pharmaceutical/clinical sciences or related disciplines with the major in Gynecology or Maternity 2.Either at least 2 years of international pharmaceutical industry experience in clinical study planning, execution, reporting and publishing activities or at least 4 years of clinical experience in Gynaecology/obstetrics or Gastroenterology 3.Good understanding of the overall drug development process, clinical trial methodology, China regulatory environment, ICH/GCP Guidelines and International regulations 4.Fluent in both English and Chinese. 望大家相互转告，希望为大家提供合适的机会，谢谢 职位如下： CRP The Clinical Research Physician (CRP) is a member of the newly established Company R&D site in Beijing with reference to the Clinical Science Manager. In this position, the CRP has a key role in developing the strategies and plans of clinical research leading to product registration in China. The CRP is responsible for preparation of the clinical/regulatory documents and acts as an in-house medical expert in close collaboration with the Clinical Operations team The ideal candidate is required to have a medicine degree and clinical/research experiences in the therapeutic areas of Gastroenterology or Gynaecology/obstetrics. Previous experiences in clinical development in a MNC will be advantageous. It is essential that the candidate has good English skills both in writing and verbal communication in order to interact with the headquarter in Europe. It is expected that the candidate is highly-motivated, proactive and has an ability to work in a dynamic team. Responsibilities 1. Identify and develop clinical research strategies in China for Company products in specialty area 2. Develop the content writing of clinical research related documents including clinical trial protocol, Investigator’s Brochure, clinical study report etc. to support clinical trial research and meet local registration needs 3. Contribute to the preparation of the dossier and providing answers to the CDE (Center of Drug Evaluation) in a timely fashion during any stages of clinical trial proceeding 4. Support approval of clinical and strategic initiatives from IPCs and/or local regulatory authorities 5. Ensure ICH-GCP, local regulatory and global policy compliance 6. Ongoing review and develop SOPs as well as standard documentation tool kits applicable to clinical operations in China 我们的联系方式： Queena. Yang 010-52898103 queenayang@toptconsult.com. [ Last edited by May2012 on 2012-8-8 at 10:49 ] |
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