• 无工作经验
  • 招4人
  • 11-09 发布
  • 五险一金
  • 周末双休
  • 节日福利
  • 年底双薪

职位描述

职位描述: 岗位职责:1.接受临床试验项目,制作临床试验项目医学方案初稿。2.根据上级、临床监查部、统计部意见修改医学方案。3.编写项目方案、研究者手册、知情同意书、研究病历、CRF、PPT初稿。4.参加协调会,按照医学总监认定的方案及资料,演示PPT,听取并记录协调会专家意见,据此修改方案。5.根据伦理会意见对方案进行调整。6.项目试验过程中,就研究者、项目运营经理(监查员)提出的技术问题答疑。7.接收统计部统计报告初稿,撰写小结、总结报告初稿,并与统计部、项目运营经理沟通,就总结报告做相应的调整。8.制作答复意见及发补文件的初稿,经医学总监审定后,答复审评中心的质疑。任职要求:1.临床医学专业,本科及以上学历;2.熟悉临床多发病、常见病、熟悉临床试验相关的法律法规;3.熟悉使用word、excel、ppt等办公软件及相关办公设备;4.具有良好的英文听说读写能力;5.有积极的工作态度,强烈的责任感和良好的团队合作精神,能承受较大工作压力;6.具有较强的创新思维能力、逻辑组织能力、文案写作能力和沟通协调能力。 职能类别: 其他

联系方式

北京市石景山区苹果园路2号院通景大厦602-603

公司信息

诚 聘 英 才 国信医药科技(北京)有限公司是一家活跃在医药咨询及医药研究领域的专业服务提供机构,作为国内领先的CRO公司。国信医药以“专业性、高效性、优质性”的宗旨,为国内外医药企业和新药研究机构提供临床试验研究、研发专业技术和医药信息咨询等相关服务。 国信医药与卫生部、国家食品药品监督管理局、国家中医药管理局等相关部门及检验机构有着长期、良好的合作关系。拥有一批由此领域内的资深专家组成的专业顾问团队,凭借广泛的社会资源、畅通的服务渠道,以及对相关政策法规、申报流程的深入了解,目前和众多企业合作并已为多家企业成功申报。公司致力于为国内外优秀企业提供全方位、专业化的研究咨询服务,主要业务范围包括医药产品临床试验的组织和运作管理,药品、器械、保健品注册及市场准入服务,医药行业市场研究与咨询,为更多的优秀产品进入市场提供一个良好的服务平台。合作客户包括大型跨国制药公司、国内研发型制药企业、相关政府机构以及专业学术团体等。 Beijing Guoxin Ze Ding International Medical Technology Co., Ltd. Beijing Guoxin Ze Ding Technology Co., Ltd. is an international pharmaceutical active in the field of medical consultation and medical research of professional service providers, as a leading CRO company. Guoxin Ze-ting of "professionalism, efficiency, quality," the purpose of domestic and foreign pharmaceutical companies and research institutions, clinical trials, drug research, reporting and registration matters and other related medical information consulting services. Guoxin Ze-ting with the National Ministry of Health, the State Food and Drug Administration, the State Pharmaceutical Administration and other relevant departments and inspection bodies have a long-term good relations of cooperation. This area has a group of senior experts team of professional consultants, with a wide range of social resources, smooth service channels, as well as relevant policies and regulations, in-depth understanding of reporting procedures, as of now, our company has many businesses establish long-term stable cooperative relations and to assist enterprises to declare the successful completion of registration. The company is honesty, with excellent consulting team-based, the emphasis on contract and credit, friendly cooperation and common development of the spirit of commitment to outstanding Chinese and foreign enterprises to provide comprehensive, professional research and consulting services to major lines of business the scope of clinical trials of pharmaceutical products, including the organization and operational management, pharmaceuticals, equipment, health care products registration and market access for services, the pharmaceutical industry market research and consulting with our high value-added brands, high-quality personnel, efficient style and the cautious attitude of the excellent enterprises for more excellent products into the market provide a good service platform. Co-clients include major multinational pharmaceutical companies, domestic well-known pharmaceutical companies, relevant government agencies and professional academic organizations. 有意者可将详细简历发邮件(fengsihan@gxzdpharma.com)至我公司。

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