Medical Science Manager（上市前临床试验）医学经理招聘_安斯泰来制药（中国）有限公司最新招聘信息-猎才医药网

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职位描述： Accountability：I.Tracking and acknowledging the progress of the related therapeutic areas of the new pipeline for ACN and headquartera)Acknowledging the guideline, academic progress and trends of the related therapeutic area, reading related reference/documents, attending academic conferenceb)Reading internal data, grasp the pipeline informationc)Effective communication with KOL, understanding Chinese clinical practice and clinical requirementsd)Discussing and drafting CDP of new pipelineII.Reviewing/Composing clinical study protocol based on development strategy of headquarter and requirements of Chinese registration and clinical practicea)Closely consulting with headquarter, acknowledging the development strategy of headquarterb)Understanding the details of the protocol, confirming reasonable protocol design after communicating with development department (Development Regulatory Affairs, Development Clinical Department, Data Management and Statistician, Development Strategy & Management Manager), PV & QA Department, RA & Supply & Sales management Department, external experts (Clinical Experts, Statisticians, Pharmaceutical Experts) and CDE reviewersc)Working closely with project team members, draft review process and timeline of the protocold)Reviewing/Composing clinical study protocolIII.Medical monitoring and giving scientific medical support for ongoing clinical studiesa)Composing and executing medical monitor plan with discussing among project members based on project requirementb)Familiar with clinical study process, conducting regular medical review on clinical data cooperating with project membersc)Solving medical questions of the protocol (e.g. medicine background, inclusion/exclusion criteria, combination medication, dosage adjustment of the study drug and discontinuation criteria et al.)d)Working closely with project team members, discussing and reviewing clinical study related documents and timelineIV.Reviewing and composing CSR and giving medical support for disclosure and publication of the clinical study resultsa)Familiar with the requirement of the clinical CSR, Scientific analyzing and discussing for the clinical data, reviewing/composing clinical CSRb)Working closely with project team members, discussing and drafting review process and timeline of the clinical CSRc)Giving medical support and comments to the disclosure and publication of the clinical study dataV.Supportive for IND and NDAa)Drafting CDP and giving medical support with discussing among project members for the submitting and approval of the IND and NDAb)Working closely with Development Regulatory Affairs, answering medical questions from CDE reviewers, and preparing medical documents and solving medical issues for the CDE consult meetingVI.Othersa)Based on the work arrangement Qualifications：1.Master’s degree in Medicine, oncology background preferred2.ICH/Chinese GCP3.Compliance and Pharmacovigilance4.Pharmaceutical industry environment5.Clinical development process6.Medical Master or above Skill7.Fluency in English8.Excellent in oral presentation both in English and Chinese9.Be good at communication10. Excellent negotiation skill11.Significant training/experience of Medical Writer or Medical Monitor[at least 2 years] in clinical development in the pharmaceutical industry 职能类别：生物工程/生物制药临床研究员关键字：医学经理临床试验 Medical 上市前上市前

公司信息

安斯泰来集团介绍：安斯泰来制药集团是一家总部位于日本东京的研发型制药企业，在全球范围内研发、生产、销售创新型医药产品。我们的使命是不断提升企业价值，致力于通过创新可靠的医药产品为全世界人民的健康做贡献实现我们的存在意义。安斯泰来制药集团已经在器官移植领域和泌尿领域成为全球专业治疗领域领导者（GCL）。我们结合自身的研发实力，锁定了五个重点研发领域，包括免疫/感染、泌尿、肿瘤、神经科学和糖尿病合并症/代谢性疾病。在2010财务年度 (2010 年 4 月至 2011 年 3 月) 全球净销售额达 9539 亿日元（97 亿美元）。安斯泰来已经成为日本第二大处方药品公司，全世界排名 20位的制药企业。目前全球员工约 16000 人。如欲了解更多详细信息，请登录安斯泰来集团全球网站http://www.astellas.com/en/。安斯泰来中国介绍：安斯泰来制药（中国）有限公司（以下简称“安斯泰来中国”）是由原“山之内制药（中国）有限公司”于2005年8月更名，再于2007年4月1日，与“藤泽药品（中国）有限公司”合并而成。安斯泰来中国以“通过提供创新而可靠的医药产品为世界人民的健康做贡献”为经营理念，秉持高度的伦理观和道德观，开展合乎法规的经营活动。在提升企业价值的使命下，发挥创造性，实现业务的持续发展，力图在中国成为受到客户、员工、相关企业、社会团体等利益相关者信赖的企业。安斯泰来中国是安斯泰来制药集团在中国投资的全资子公司。工厂位于沈阳经济开发区，总部设在北京，在上海、北京、广州、成都、武汉、青岛和沈阳设有分公司，业务范围遍及全国大中城市，全国约有员工1000名。安斯泰来中国目前在中国上市销售9个产品，涉及器官移植、泌尿、感染、皮肤、消化循环等多个专业领域，其中已经在器官移植和泌尿领域得到广大医生和患者的认可，处于市场领先地位。如欲了解更多详细信息，请登录安斯泰来中国网站http://www.astellas.com.cn.

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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