Regulatory Affairs Officer 北京

月薪： 1.5-2万/月

该公司所有职位
  • 2年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 餐饮补贴
  • 通讯补贴
  • 交通补贴

职位描述

职位描述： PURPOSEPrepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. With guidance from senior staff, provides regulatory support for more complex projects.RESPONSIBILITIES? Acts as a Regulatory Team Leader on more complex projects, which may include technical writing.? Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.? Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments.? Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate.? May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.? May present to clients on complex regulatory processes at large full service bid defence meetings by phone or in person.? May act as reviewer for regulatory SOPs, as assigned and appropriate.? May prepare and deliver regulatory training to Quintiles small groups or individuals.? Performs other tasks or assignments, as delegated by Regulatory management.All responsibilities are essential job functions unless noted as nonessential (N).REQUIRED KNOWLEDGE, SKILLS AND ABILITIESPossesses a specific regulatory or technical expertiseGood, solid interpersonal communication (oral and written) and organisation skillsStrong software and computer skills, including MS Office applicationsDemonstrates self-motivation and enthusiasmDemonstrates negotiation skills and is confident in making decisions with minimal supervisionAbility to work on several projects, retaining quality and timelinesAbility to follow SOPs consistently; provides independent thought to assist in process improvementsMINIMUM REQUIRED EDUCATION AND EXPERIENCE? Degree in life science-related discipline or professional equivalent plus at least 3 years relevant experience* or high school diploma plus at least 7-9 years experience* (*or combination of education, training and experience)PHYSICAL REQUIREMENTSExtensive use of telephone and face-to-face communication requiring accurate perception of speechExtensive use of keyboard requiring repetitive motion of fingersRegular sitting for extended periods of timeTravel will be required 职能类别： 生物工程/生物制药 关键字： 药品或器械 注册经验

联系方式

北京东城区王府井大街

公司信息

QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you.

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