• 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述: Job offer: CLINICAL TRIAL SUPERVISOR We are going to recruit a Clinical Trial Supervisor for our subsidiary based in Shanghai (200 employees, 200 MRMB in Sales with aggressive and exciting plan in China); the position is based in a downtown location in Shanghai with regular trip within mainland China and occasionally in APAC and Europe.This is a company operating in the pharmaceutical industry and this locally on the entire value chain (development, formulation, production, sales);The Clinical Trial Supervisor / Clinical Search Supervisor will report to Regulatory & Medical Affairs Director 3 years local contract with 6 months probation period.Job Responsibilities: -Maintains a level of medical-scientific knowledge in an assigned therapeutic area and/or disease state(s) involving clinical issues related to relevant products-Organize and manage the clinical trial for the purpose of registration and marketing promotion.-Draft the protocol for the BE study and clinical trial.-Responsible for the project plan and budget for clinical trial.-Ensure that clinical trial compliance with the policies, protocol, schedule and SOP.-Participate in the new product launch activities as a medical expertise for explaining some medical background/ clinical results and answering related questions.-Cooperate With other departments to carry out research projects and the evaluation, particularly in the clinical part of the assessment-Organize and manage the clinical trial. Monitor the entire clinical trial process, familiar with the clinical trials from Phase I to Phase IV.-Responsible for choosing the institution, draft the agreement and negotiate for clinical trial. -Responsible for the project all kind of coordination work in the implementation process. Keep and Maintain good communication and coordination with researchers,-According to the testing requirements for the project to properly establish and manage the documentation.-Provide the clinical trial document for the drug registered.Marketing missions -Keep contact with specialists in medical field to obtain certain marketing information.-Regularly retrieve medical and marketing information for related products.Relationship Management -Active participation, communication and collaboration with R&D team, BD, Marketing and Project department.-Creative, Team player, problem settled and work under pressure-Build lasting relationships with clients and prospects-Maintain good working relationships with colleagues, senior and junior colleagues across the business unit. MANDATORY KNOWLEDGE – SKILLS AND ABILITIES-Master's degree major in medical science or pharmacy- At least 3 years relevant experience with multinational pharmaceutical company, Experience as a doctor in hospital is preferred-Fluent and professional English and Mandarin (writing and speaking)-Existing network and relationship in pharmaceutical industry-Natural commercially oriented and experienced in business development in pharmaceutical industry in China -Knowledge of China pharmaceuticals market, rules and regulations on drug development -Clinical research experience, project management experience and experience in clinical operations; or equivalent combination of education, training and experience in depth knowledge of, and skill in applying -Familiar with applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines DESIRED KNOWLEDGE – SKILLS AND ABILITIES-Depth therapeutic and protocol knowledge -Ability to set up the budget and control costs-Strong organizational and problem solving skills -Demonstrated ability to deliver results to the appropriate quality and timeline metrics -Good team leadership skills, good judgment and effective presentation skills -Establish and maintain effective working relationships with clients.-Software and computer skills, including MS Office applications 职能类别: 临床协调员 药品注册

联系方式

上海市南京西路388号仙乐斯广场1805-1806室

公司信息

爱的发制药集团是以研发为主导的国际化药物释放技术公司,公司拥有一系列的药物释放技术平台,可以满足从传统小分子到生物大分子递送的各种要求,基于其全球的5个研发中心和4个生产基地,62组全球性的专利保护,爱的发为客户提供从研发、注册到生产的全方位服务。 目前,公司已经拥有超过1600项的市场授权,为50多个化合物开发了不同的配方,爱的发将产品授权客户,在70多个国家上市,包括诸多知名跨国公司在内的超过200家制药企业选择爱的发作为他们信赖和合作伙伴。 作为第一批中法合作的制药企业,上海爱的发成立于1995年11月,基于其创新的药物释放技术,上海爱的发在中国开发和上市了一系列产品,并为客户提供包括可行性研究、工艺放大、临床实验、注册和工业化生产的全方位服务;作为中国药物释放产业的领军企业,上海爱的发通过提高现有产品的治疗效能和竞争力,帮助合作伙伴延长产品的生命周期和专利保护,而所做的提高和改进都达到或者超过生产规范国际标准的要求。

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