职位描述
职位描述: 医学经理 (上海)工作内容 1.临床研究项目的资料搜集整理,起草或修订临床试验方案、研究者手册、病历报告表、知情同意书、临床总结报告等试验相关文件。 2.指导制定或修订本部门医学资料撰写相关操作的SOP,并对相关人员进行培训。 3.定期收集整理临床试验过程中发生的严重不良事件或非预期不良事件,跟踪收集国内外相关药物的不良反应的信息,并与项目组及研究者进行沟通、讨论。 4.协助其它部门对公司拟引进的新品种中涉及临床应用及医学实践等部分内容进行评估及沟通。 5.跟踪相关领域的医学进展。 6.根据临床试验结果及文献撰写医学专业文章。 7.医学总监或项目负责人交办的其它医学相关事宜。 8.定期(或及时)向部门负责人汇报工作实施情况。 职能类别: 生物工程/生物制药
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。
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