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  • 2021-11-12

    (Sr.) Manager, Translational Medicine/Biomarker Management

    第一三共(中国)投资有限公司

    职位描述:Specific Responsibilities:Lead Translational Medicine activities in China1.Develop and support local translational biomarker strategy aligned with global strategy2.Provide the technical inputs in terms of China HGRAC regulation and local practice to Translational Translational Lead and Clinical Biomarker Lead in the evaluation and development of clinical biomarker assays and testing sites for early and late stage oncology projects in China3.Provide relevant area expertise for improving the quality of biomarker testing to support early and late phase clinical development in China4.Contribute...

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  • 2021-10-27

    助理注册事务经理--北京

    第一三共(中国)投资有限公司

    职位描述:具体职责:1、参与对肿瘤新产品开发策略的讨论和评估,并对开发计划的制定提供意见和建议;2、收集项目相关的最新法规信息并咨询和征集专家的意见,反馈给项目团队;3、对新产品的开发计划提出资料准备、注册提交和审批时间的建议;制定新产品临床试验或上市申请的计划和时间表;4、完成IND和NDA 注册资料的准备、审核、提交、跟踪和审批,及时反馈并解决项目进展过程中的问题;5、组织和推进注册检验、GCP检查、GMP检查的准备、协调、进...

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  • 2021-08-30

    注册科(高级)经理--上海

    第一三共(中国)投资有限公司

    职位描述:具体职责:1、参与新产品的前期注册分析、评估与规划、策略和计划制定并执行;2、组织项目管理团队,准备并完成沟通交流会议资料、临床试验申请资料、上市申请资料并提交;3、积极跟踪审评进度并与审评人员沟通,及时组织团队完成发补要求资料并取得批准;4、审核团队成员准备的提交资料并保证符合质量和法规要求;5、协调并支持临床试验GCP检查和生产基地GMP检查和注册检查;6、对已上市产品变更和再注册项目进行评估,制定策略和计划...

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  • 2021-05-07

    Development Coordination & Project Management Manager

    第一三共(中国)投资有限公司

    职位描述:Responsibilities:1. Work with cross-functional team members to create product development plan, clinical development plan and budget estimations for China, track project activities, ensure identification and receipt of key deliverables, establishment and monitoring of timelines and conduct work stream follow-up activities to ensure timely completion of tasks.2. Develops, tracks and adjusts cross functional product development plan (timelines, budget, project documentation) in close interaction with different global/China functions and adjusts during compound development where nece...

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  • 2021-04-13

    (高级)临床研究经理

    第一三共(中国)投资有限公司

    职位描述:Responsibility:1、To prepare the new drug development budget and resource for clinical study execution.2、In terms of DD annual goal of development, participate in Clinical annual development plan and resource budget for responsible study.3、To be responsible of individual study quality control and management, ensure clinical study execution strictly following with study protocol, relevant SOPs and China regulation, oversight clinical study initiation, execution and completion, coordinate the efficient communication within internal and external team member.4、Work with team member to co...

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  • 2021-03-10

    注册事务(高级)经理

    第一三共(中国)投资有限公司

    职位描述:Responsibilities:1、Discuss and develop the registration strategies for new oncology products/projects, and contribute opinion and proposal for development plan;2、Provide the opinion related to documents preparation, submission and review timeline on the new product development plan; develop the IND and NDA submission plan and timeline;3、Complete IND and NDA documents preparation, QC check, submission, review follow up and approval, and timely reflect and resolve the issues during the review process;4、Organize and promote the preparation, coordination, progression and completion of Q...

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