Regulatory Affairs Manager 北京

月薪： 2.5-3万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 年终奖金
  • 通讯补贴
  • 餐饮补贴
  • 弹性工作
  • 定期体检

职位描述

职位描述： RESPONSIBILITIES? Acts as a Lead Regulatory Professional on any type of writing or technical project, with limited guidance from senior staff using experience and initiative to generate new and unusual document types to meet customer requirements.? Provides strategic regulatory and/or technical consultancy on a variety of projects and provides senior review and guidance for most documents prepared by junior colleagues.? May act as a Project Manager for a stand-alone project, with full project management responsibility.? May prepare a single service regulatory or technical proposal for senior review and/or propose budgets for less routine projects, out of scope activities and potential budget efficiencies. Deliver business development presentations to customers with confidence and detailed knowledge, as directed.? Independently meet with customers face to face to discuss project status. Identifies creative solutions to challenges that are acceptable to Quintiles and customers, thereby consistently receiving positive customer feedback.? Ensures compliance with regulatory processes, ensuring readiness for internal or external project audits.? May design training materials and deliver training externally and internally.? May represent region or site on a regulatory, technical or cross functional Initiative.? 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 ABILITIESExtensive experience in regulatory and/or technical writingAdvanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customersStrong software and computer skills, including MS Office applicationsSets a positive example to more junior colleagues relating to a professional manner, positive attitude and communication style with customers and colleaguesMay take calculated risks when making decisions, seeking guidance from Regulatory management, as appropriate; demonstrates autonomy and initiative, as appropriateAbility to earn respect from peers in other operational groupsMINIMUM REQUIRED EDUCATION AND EXPERIENCE? Degree in life science-related discipline or professional equivalent plus at least 5-6 years relevant experiencePHYSICAL 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 (< 5%) 职能类别： 药品注册

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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