• 无工作经验
  • 招1人
  • 11-09 发布

职位描述

职位描述: 岗位职责: 1.高级临床监查员(senior cra)主要参与临床试验中心的筛选,crf表设计等前期准备工作; 2、负责各中心临床试验启动,解答疑难问题; 3、负责监查临床研究质量,跟踪研究进度及临床试验工作协调等; 4、协助项目经理完成样品发放、合同付款、总结报告等工作; 5、发生严重不良事件,及时向项目经理报告。 任职资格: 1、医药相关专业本科及以上学历,硕士优先考虑2、至少2年以上临床试验项目工作经验,具有2-3期临床试验中任意1期项目操作经验; 3、项目涉及至少1个适应症,肿瘤和自身免疫适应症优先; 4、经历过临床试验操作的所有环节; 5、具备出色的沟通能力、团队组织及建设能力、危机处理能力。 职能类别: 生物工程/生物制药

联系方式

杭州

公司信息

三生国健药业(上海)股份有限公司(简称“三生国健”): 2002年,中国中信集团与兰生国健药业发起投资成立生物医药高新技术企业——上海中信国健药业股份有限公司;2015年,香港上市公司三生制药进行股权投资成为该公司最大股东,并将公司更名为三生国健药业(上海)股份有限公司。十几年来,三生国健始终专注于抗体药物研发、中试和产业化,已成功建立了拥有自主知识产权的抗体药物研发平台,掌握研发与产业化的核心技术并参与多个抗体药物质控国家标准的建立。公司拥有通过国家食药监总局(CFDA)GMP认证的3条750升、2条3000升抗体药物生产线;符合欧盟标准的6条5000升抗体药物生产线于2015年完成建设并成功试生产,生产规模和质控水平位居国内行业领先地位。三生国健提供覆盖自身免疫、肿瘤、抗器官移植排斥反应等重大疾病领域的靶向药物,具备持续开发新药的能力,现已发展成为国内抗体制药领域的领军企业。 简介(英文): Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (Sunshine Guojian),whose predecessor is Shanghai CP Guojian Pharmaceutical Co., Ltd. jointly invested in 2002 as a biomedical high-tech enterprise by China CITIC Group and the Lansheng Guojian Pharmaceutical Co., Ltd., is established in 2015 and integrated into the Sunshine Pharmaceutical Group, a Hong Kong listed company, upon equity investment. Over the past decade, Sunshine Guojian has committed to the R&D, pilot scale development and industrialization of antibody drugs. The company has built up a self-owned antibody drug discovery platform with core technologies and know-hows, as well as led or participated in drafting of national standards in antibody drug quality control. Sunshine Guojian’s antibody drug production lines (3*750L and 2*3000L) has been granted the GMP certificate by CFDA and its new production lines (6*5000L) by EU standards were completed construction and realized successful trial production in 2015, leading in production scale and quality control in the domestic industry. As a leading player in the field of domestic pharmaceutical antibody, the company provides targeted drugs for autoimmune diseases, cancer, organ transplantation immunosuppression treatment, with a sustainable capability of drug innovation and development. 现由于公司发展需要,诚聘具有创新精神和成就事业理想的优秀人才加盟。 请符合条件的应聘者将中英文简历等信息发送E-mail至:hr@gj.3sbio.com (请在邮件题目上注明应聘职位等信息)

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