职位描述

职位描述： ResponsibilityYou will be responsible to follow CFDA regulations, RDSL SOPs and Divisional Standards required by Headquarter, review promotional material and study from medical regulatory prospective; to draft and review the protocol and report of clinical study for product registration propose, according to the relevant CFDA and global regulations, guidance, standards and RD SOPs; and to handle 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，起草和审查产品注册临床试验的方案和报告；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 corresponding event applications to make sure compliance with Dia Symphony and related SOP's, Good Clinical Practice (GCP) and HCP guidelines; Reviewing HCP PPTs and Roche promotion materials to ensure no off-label promotion; 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。审核 HCP 幻灯片和罗氏推广材料以确保没有注册证外的推广- Drafting and reviewing the protocol and report of clinical study for product registration propose, 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，起草和审查产品注册临床试验的方案和报告- 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- Monitoring the change of regulation and technical guidance, participating actively in the drafting and discussion of the relevant regulation, industry standard and guidelines; 监测法规和技术指南变化，积极参加相关法规、行业标准和技术指导原则的制定和讨论- Working closely with industry associations and KOLs, representing the company participate the guidance and policy making process; 与行业协会和专家密切合作，代表罗氏参与相关政策和指南的制定过程- 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, bio-statistics, pharmacology, and biology; 医学相关专业本科及以上学历，临床医学、医学检验、生物统计、药学、生物学优先- Proficiency in both spoken and written English and good command of MS office software application. Highly effective oral and written communication skills; the ability to get ideas across one-on-in, in group settings as well as in presentation; 熟练掌握英语口语及书面表达, 熟练应用微软办公软件;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;- Understand pharmaceutical and/or medical device regulation. 了解药品及/或医疗器械法规You should have at least 5 years of working experience in clinical medicine, pharmaceutical, Medical Device, or in-vitro Diagnostics industry, and 3 years of working experience in medical compliance, medical writing, clinical monitoring, statistics, or regulatory affairs. Project management or people leader experience are preferred.临床医学、制药、医疗器械或体外诊断行业至少5年经验, 3年以上医学合规、医学写作、临床试验、生物统计、或产品注册相关经验, 有项目管理或团队管理经验者优先. 职能类别： 医疗器械注册 合规经理

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