南平招聘

Position Purpose:
? Manage Clinical Trial Insurance process to globally achieve an appropriate insurance of clinical trials sponsored by BSP, Consumer Care and their affiliates, in cooperation with the Pallas AG
? Investigator Brochure (IB) Management to globally achieve an timely global availability and update of Investigator Brochures for BSP projects
? Contribute to continuous improvement of Clinical Trial Insurance and IB Management related systems and processes
? Point of contact in terms of operative Clinical Trial Insurance and IB related issues
? Trigger the central process for archiving the BSP Clinical Study Protocols in BSP’s archiving system

Major Responsibilities:
? Trigger timely insurance for clinical trials based on business requests by following the internal Clinical Trial Insurance processes defined
? Formal quality control of the mandatory data on clinical trials that needs to be available acc. to existing standard processes, local legal regulation, and existing insurance contracts, and trigger the Clinical Trial Insurance process accordingly
? Serve as communication link to Pallas AG, to local insurance companies, and to internal business partners for Clinical Trial Insurance related issues
? Provide regular reports on insurance issues based on business needs and requests from Pallas AG and internal business partners
? Send the Clinical Study Protocols which were received in the Clinical Trial Insurance process to the CSP Archive function, which will provide these as central point of reference
? Tracking of timely preparation and timely yearly review or updates of BSP IBs
? Storage and archiving of IBs and amendments to IBs in the central globally accessible IB database to serve as central point of reference in this matter
? Manage Bayer’s IB repository database

Education, Know How and Experience
? Degree in Life Science, or equivalent professional experience
? Experience in clinical development related to clinical trials
? Good understanding of ICH/GCP regulations
? Understanding global legislations, regulations and guidelines

Special skills
? Ability to understand different Clinical Trial Insurance requirements worldwide
? Strong written and oral communication skills, especially in English language
? Solid document management and communication management skills
? Good understanding of IT processes and databases used in Clinical Development, especially Clinical Trial Management Systems, Clinical Trial Posting System, and Document Management Systems; otherwise IT skills at user level
? Good player in global, cross functional teams
? Strength to work accurately on detail level
? Ability to overcome complexity
? Understanding of drug development process over different stages

拜耳医药保健是拜耳集团的子集团，是世界十大医药企业之一，也是医药保健及医疗产品行业世界领先的创新企业之一，全球拥有员工53100人，总部位于德国的勒沃库森。拜耳医药保健致力于研究开发、生产和销售用于预防、诊断和治疗疾病的原研产品。2008年，拜耳医药保健全球销售额达154.07亿欧元，其中研发经费为17.42亿欧元，占拜耳集团总研发投入的66%。

拜耳医药保健和中国的渊源可以追溯到20世纪初期。早在1936年，拜耳就在中国成立第一个生产公司－拜耳医药公司，生产一系列产品。目前，拜耳医药保健有限公司在中国拥有员工约4000人，总部位于北京。在北京、广州、成都、江苏设有工厂，致力于拜耳先灵医药、保健消费品、糖尿病保健及动物保健四大业务。其中，拜耳先灵医药是拜耳医药保健有限公司下属最大业务部门，是拜耳医药保健的处方药部和先灵（广州）药业有限公司合并而成，业务遍及70多个城市，产品线覆盖普药业务、女性健康、特殊治疗以及影像诊断四个领域。2008年7月，拜耳医药保健的保健消费品部收购了东盛盖天力西药非处方药业务。
        
2008年，拜耳医药保健完成了投资达2.2亿余元人民币的北京生产厂的扩建。 北京工厂新建的生产线将采用目前中国乃至亚洲地区最为先进的设备，产能是以前的4倍。除了硬件系统投资，拜耳医药保健北京工厂还引入先进的软件管理系统，包括全自动称重系统、物流管理系统等将使得药品的品质更上一层楼。

拜耳医药保健有限公司在中国的发展蒸蒸日上。

在业务发展的同时，拜耳医药保健始终不忘社会责任，积极与社会各方面进行深入合作。2008年11月，与中国就业促进会合作开展了“农业富余劳动力健康安全转移就业培训项目”，计划在3年内对3万名农业富余劳动力免费提供健康安全转移就业培训。尽管目前处在全球经济困难期，我们仍将继续关注那些需要帮助的社会弱势人群。

为促进并提高中西部地区县级医院的整体医疗服务技术水平，2008年拜耳医药保健和卫生部合作的“走进西部”万名县级医院医师培训项目成功开展。目前已在甘肃、青海、宁夏、云南四省进行了６期培训工作，已有３６３人参加了培训。２００９年“走进西部”项目还将延伸到江西、广西、陕西、贵州、新疆等五个省份，共计划培训１１２２名医生。

2009年初，拜耳医药保健新的研发中心将在北京落户，成为其全球架构中的第四大研发中心。这一举措不仅表明了我们在中国长期发展的决心和信心，并为拜耳医药保健成为亚洲制药领域的领导者提供坚实基础。