蚌埠招聘

Company Description:

BHC

Department Description:

Medical- MA-xarelto

Tasks Description

Position: Major Tasks

1. In clinical trials:
？ Supports country selection, feasibility assessments, investigator
identification and initial medical discussions with investigators
？ Supports development of study specific documents such as protocol
writing of specific sections including inclusion/exclusion criteria,
amendments, review and approval of the PI/IC, and review of CRF and
Statistical Analysis Plan
？ Develops standard training material, is involved in training
Study
Team members and site staff on medical aspects of the study, and
provides support for medical topics and questions
？ Writes medical review plan, performs ongoing medical review of
clinical data, Attends blinded review meeting, approves final patient
validity, and provides final sign-off on unresolved data queries
？ Reviews statistical tables, identifies additional analyses,
interprets clinical data, prepares narratives for CSR and reviews final
study CSR, writes Chinese Clinical Research Report
？ Contributes to regulatory INA and NDA submissions and clinical
publications
？ Prepare the medical section of briefing documents for
discussions/meetings with regulatory authorities
？ Develop responses to study-specific medical issues that may be
raised by regulatory agencies
2. In marketing support:
？ Co-operate with marketing function to commercialize new products
to the market.
？ Review and provide medical information for marketing materials.
？ Develop and organize local NIS, is responsible for the proper
processing of local/global NIS according to global standards or local
procedure.
？ Responsible for ISS submission, as a contact person with
investigators to carry out ISS and work closely with external patterns
to ensure ISS be in good quality.
？ Oversees, executes and coordinates internal participants for
medical events, provides content support to Marketing at conferences and
meetings, and participates in important congresses
？ Provides scientific analysis of relevant competitive data and
offers helpful positioning in the management of problem situations



Requirements Description


Education:
？ Master or above degree in clinical medicine
Skills:
？ Proficiency in Basic Microsoft Word, PowerPoint and Excel
？ Fluency in English
？ Excellent communication skill
Experiences:
？ At least 2 years clinical experience
？ At least 5 years international pharmaceutical industry
experience
？ Management at least 2 years
Knowledge in :
？ Assigned therapeutic areas, clinical experience is preferred
？ Chinese/ICH GCP guidelines and SOPs
？ Drug development process
？ Clinical trial methodology
？ China regulatory environment
？ Pharmaceutical industry compliance rules
Personal characteristics
？ Open and proactive
？ Team work

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。