商丘招聘

Regulatory compliance  

 ·     Coordinate comments collection and impact assessment to the local new/revised regulations with cross functional departments and document results offline or within systems Process compliance

 ·     Support with the local impact assessment of global R&D procedural documents and, if applicable, support development and coordination of associated local procedural documents Quality culture building

 ·     Share global regulatory intelligence news or quality & compliance knowledge to targeted local teams Clinical trial registry

 ·     Conduct clinical trial registry on CDE-NMPA platform within required timelines 

 ·     Technical review and quality check for the CDE Registry Form Administrator

Requirements

·         Knowledge of the overall drug development process

·         Knowledge of business processes and practices (i.e., SOPs governing clinical research activities)

·         Experience of the key customers’ business processes and practices

·         Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development

·         Experience with regulatory submissions (NDA, BLA) is an asset

       FESCO，中国人力资源行业创始者，中国500强企业。为全球在华万余客户提供全方位人力资源解决方案,包括人事福利外包、招聘测评、外籍人服务、专业外包、专业咨询等。
    北京外企服务集团有限责任公司（FESCO）成立于1979年，是我国人力资源服务行业具有开创意义的***家企业。经过近40年发展，外企集团已经发展成为一个以人力资源外包服务为主，涉及旅游会展、文化传媒、房地产物业等相关领域的企业集团。