长沙招聘

职位描述：
Area of Responsibilities:
- To work for preparing and conducting IVD or other medical advice clinical trials which are needed by registration in China;
- Communicate with CRO or own for the trial preparation, such as protocol design;
- Work with CRO or own to conduct investigator selection, investigator meeting, and EC submission;
- Work with CRO or own the clinical trial approval;
- Work with CRO or own the clinical trial filing in Shanghai FDA;
- Track to meet target including source data verification, timeline, enrolled sample number etc.;
- Co-monitoring with CRA/CRO to ensure trial quality compliance with the requirement of GCP, SOPs and local regulations;
- Managing document filing according to the requirement of SOP;
- Establish clinical trial SOPs;
- Execute the clinical trial plan to get the clinical report and other required document in a target timeline;
- Adhere to policies and procedures.
Person Specification:
Qualifications & Education:Bachelor degree or above,Major in Medical or Pharma or Biomedical preferred
Skills & Knowledge:Familiar with CFDA regulation and clinical trial regulation,Priority given to those who have the experience on in vitro diagnostics,1 years above hands-on experience with the CFDA regulations for product registration of MD/IVD
Personal Skills / Attributes:-Good coordination with internal and external departments,Positive communication,Good attitude, well habit of work, positive & take responsibility

作为全球500强美国丹纳赫集团旗下知名公司之一的徕卡显微系统，是显微镜和科学仪器领域的全球先驱。公司开创于十九世纪，从家族企业发展至今已有160多年历史。如今的徕卡已成为全球知名企业，以无可匹敌的创新精神延续辉煌历史。
 
徕卡显微系统总部设在德国的韦茨拉尔 (Wetzlar)，在全球 100 多个国家设有代表处，在 7 个国家设有 12 个制造基地，在 20 个国家设立了销售和服务机构，并且设有全球性的代理商网络。
 
自1995年进入中国以来，始终秉承"与用户合作，使用户收益"的宗旨，凭借业界领先的产品性能和系统全面的解决方案， 成为了中国显微镜行业中的佼佼者。公司涉及的领域有生命科学研究、工业和医疗手术。
 
截止2013年底，徕卡在中国已有7家办事处，销售和服务网络涵盖了包括香港在内的16个区域，年销售额超过1亿美元。在上海建有生产基地和研发中心，员工超过300名，生产总额超过2500万美元。


Leica Microsystems, as a member of Danaher Group in the USA, which ranks the Fortune 500, is a world leader in microscopes and scientific instruments. It has been 160 years since the family enterprise was founded in the nineteenth century. The Company’s history was marked by unparalleled innovation on its way to becoming a global enterprise.


Leica Microsystems is headquartered in Wetzlar, Germany. The company has established offices in more than 100 countries, 12 manufacturing facilities in 7 countries, with sales and service organizations in 20 countries as well as global dealer network.
 
The company has become the leader in China microsystem industry with its leading products and systematic and comprehensive solutions with the commitment of “Cooperate with the customer and benefit the customer” since it came into China market in 1995. At global level, Leica Microsystems is organized in three divisions, Life Science, Industry and Medical.
 
As of the end of 2013, Leica Microsystems has established 7 offices in China with sales and service network covered 16 regions including Hong Kong. The annual revenue exceeded $ 100 million. The company has manufacturing facility and R&D center in Shanghai with more than 300 employees and over $ 25 million production.公司网站：**************************