职位描述

Responsibility You will be responsible for following CFDA regulations, RDSL SOPs and Divisional Standards required by Headquarter, review promotional material and study from medical regulatory prospective; Conducting quality control on clinical trial internally, according to the relevant CFDA and global regulations, guidance, standards and RD SOPs; Handling medical regulatory inquiry from other departments and coordinate cross-functional project. 依据国家相关法规、公司相关SOP、以及总部DS系列相关指令，从医学法规角度审查宣传推广材料和研究活动是否符合相关规定；依据国家和全球相关法规、指导原则、标准及公司SOP，进行MRA内部临床试验相关质控工作；为公司其它部门提供医学法规相关问题答疑，参与协调跨部门项目。Reviewing HCP PPTs and Roche promotion materials to ensure no off-label promotion. Reviewing corresponding event applications to make sure compliance with Dia Symphony and related SOP's, Good Clinical Practice (GCP) and HCP guidelines; 审核罗氏推广材料及HCP 幻灯片以确保没有注册证外推广。审阅相关的活动申请以确保符合 Dia Symphony 及相关的 SOP, GCP 和 HCP 指南。Reviewing clinical study files for product registration propose and other quality control task, according to the relevant CFDA and global regulations, guidance, standards and RD SOPs; 依据国家和全球相关法规、指导原则、标准，及公司SOP，审核注册临床试验的相关文件及其他质控工作。Developing HCP, medical regulatory, and clinical operation related SOPs according to the requests of Dia Symphony, Divisional Standard, and GCP; 按照Dia Symphony、总部DS系列相关指令、和临床试验质量管理规范（GCP）要求，参与制定HCP、医学法规、和临床试验操作相关的SOPs。To be window person of MRA to other BAs and departments, handling inquiring and feedback; providing active and strong technical supports to internal dept. as needed; 接受来自其它部门的查询，积极主动反馈，为各部门提供及时和有力的相关法规支持Developing and maintaining a good working relationship with BAs and other dept. to support the cross-functional projects. 开拓并维护与业务部门和其他部门的良好工作关系，以支持跨部门项目 QualificationYou should hold:At least Bachelor degree in medical science degree, preferably in clinical medicine, medical laboratory, pharmacology, and biology; 医学相关专业本科及以上学历，临床医学、医学检验、药学、生物学优先Proficiency in both spoken and written English and good command of MS office software application; 熟练掌握英语口语及书面表达，熟练应用微软办公软件Understand pharmaceutical and/or medical device regulation; 了解药品及/或医疗器械法规Highly effective oral and written communication skills; the ability to get ideas across one-on-in, in group settings as well as in presentation. 高效的口头及书面沟通能力；在面对面，小组讨论及报告中都有获取关键信息的能力You should have at least 1-2 years of working experience in clinical medicine, pharmaceutical, Medical Device, or in-vitro Diagnostics industry, working experience in medical compliance, clinical operation, medical writing are preferred. Project management experience are preferred. 临床医学、制药、医疗器械或体外诊断行业至少1-2年经验, 有医学合规、临床研究或医学写作经验者优先。有项目管理经验者优先 职能类别： 临床研究员 合规主管/专员

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