Senior Country Submission Specialist 上海

月薪： 1.5-2万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 01-04 发布
  • 五险一金
  • 员工旅游
  • 通讯补贴
  • 专业培训
  • 弹性工作
  • 定期体检

职位描述

Responsibility:· Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation and providing updates of local processes and requirements to the Regulatory Intelligence portal.· Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.· Compile and submit CTAs to Regulatory Authorities and IRB/EC (if applicable)· Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process.· Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.· Complete review of essential documents following Essential Document Checklist QC.· Review translations of regulatory documents.· Provide regular local status updates to SSU Project Lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems for assigned projects.· Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.· Support other departments as necessary· Identify site issues during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.· Mentor junior staff on local regulations and internal procedures.· Support the development of start-up plans and essential document checklists.· May play the role of Country Expert for internal intelligence collection and training purposes.· Lead a single-country/domestic study by providing work direction and oversight to a team.· Act as study start-up project lead on projects with limited scope establishing the CTA submission strategy (Regulatory Authorities and IRB/EC).· Act as Subject Matter Expert (SME) for a specific function of EDCS in a specific project or region· Complete assigned training programs and applying learning.· Complete necessary administrative tasks. · May perform other duties as assigned.Job Qualifications:· Five (5) years clinical research/monitoring experience including four (4) years study start-up experience· Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information· Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements· Strong organizational skills· Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located· Ability to work independently in a fast-paced environment with a sense of urgency to match the pace· Must demonstrate excellent computer skills· Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade· Occasional travel may be required 职能类别： 临床研究员

联系方式

南京西路688号恒基广场

公司信息

InVentiv Health通过分布在全球70多个国家的14000名员工，为医药、医疗器械和生物工程客户提供临床研发、销售及商务咨询服务，inVentiv Health的目标是通过自身的专业服务将客户的商业理念真正地转化为现实，帮助客户提升业绩，现在inVentiv Health服务于约550家客户的850个品牌。 2011年12月，inVentiv Health在中国设立盈帆达医药咨询（上海）有限公司，正式在中国区域为医药行业客户提供服务。 inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bio-analytical services, and strategic resourcing from a single clinical professional to an entire functional team.

上海相关职位

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上海相关职位： 临床医药代表（神经免疫线） 临床医药代表（神经免疫线） 临床医药代表（神经免疫线） 制剂主管 Regulatory Affairs Manager or above PV Manager/ Sr. Manager 药理、毒理研究员 DMPK 生物分析研究员 细胞免疫治疗研发人员 研发总监（肿瘤免疫方向）

周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南

企业入驻日期： 2017-11-09

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