Jobs In Beijing, Beijing

Regulatory Affairs Sr Mgr

**Job Summary:** n Develop China registration strategy and implement regulatory submissions (IMPD, CTN, MAA) for products within Amgen’s portfolio in compliance with corporate standards and local regulatory requirements. n Develop HA communication strategy for critical issues, apply for & organize HA meeting and finalize the meeting minutes. n Undertake interactions and negotiations with Regulatory Authorities, […]

Sr Associate Regulatory Affairs – Submission

**Job Summary:** Filing and submission: + Lead submission in partnership with TA team; + Coordinate and follow the dossier package preparation; + Analyze the gaps and needs for China RA in early phase submission; + Arrange dossier package printing and binding to ensure the submission on time; + Control the package filing strategy to facilitate […]

PAPCompliance Supervisor

+ 向卫星团队中区负责人汇报,工作地点在北京,主要负责监控PAP项目执行中的风险、提升项目管理水平、项目执行效果并确保优化的项目流程。 + 对申请流程的核查, 包括初入组的新病人和随访病人 + 根据不同适应症检查被抽患者的所有支持文件是否符合要求(如:检查报告不可早于90天;特殊案例或高剂量使用等是否交予医学管委会审核后做出判断;影像原件等); + 医学条件确认表是否是指定医生或授权医生签字和盖章; + 随访表以及安全性有效性有没有按规定提交相应检查报告等工作的实施; + 定期与合作方沟通,并PAP合规委员会报告重大问题和违规情况。 + 药房工作职责的抽查 + 药师有没有按规定(见核查清单)发放药品(领药时间和领药剂量) + 定期查看药师月报 + 其他工作 + 在合作方办公室核查,同时按需现场配合核查并分析高风险案例; + 协助第三方审计的检查点 + 数据分析和报告 + 向PAP合规委员会提供月度报告,以合规、风险的危险信号供下一步计划参考; + 遵从患者信息保密性 + 项目潜在危机事件 + 向合作方领导和监管委员会汇报; + 准备必要的执行计划。 Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction […]

(Senior) Data Manager

**ROLE SUMMARY** As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Data Manager is responsible for timely and high quality data review and query management of clinical data supporting the Pfizer portfolio. The Data Manager develops and maintains key data management […]

Key Account Manager

Collect, analyze and summarize the Enterprise & Project policies, markets and data information. Work with the team to make and execute sales plans and strategies. Develop and manage Enterprise & Project customers. Promote and coordinate the implementation and completion of projects in order to achieve EPM sales and target. Danaher Corporation and all Danaher Companies […]

Senior Clinical Research Associate

+ Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. + Work with sites to adapt, drive and track the project timeline to enhance predictability. + Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. + Conduct […]

Sales Coordinator – North 1

11 Join Us If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. […]

Business Planning & Optimization Manager

Base location : Beijing or Shanghai Job Summary: The Business Planning & Optimization Mgr, under Business Optimization & Innovation of EMBU China, will help GM develop mid-to-long term business strategies covering portfolio optimization, territorial business planning, access, and talent development etc., and meantime drive the execution and change management thereof throughout the organization. Main Tasks […]

Solution Sales Assistant Manger

null **In this role, you have the opportunity to** Works as a Sales/Business Development Manager on problems of moderate scope where the analysis of data requires a review of a variety of factors using Root Cause Analysis. The development of the solution requires a multi-disciplinary approach and knowledge of basic sales/business development principles, -theories and […]

Sr. Sales Rep, DXR-North Private

null **In this role, you have the opportunity to** Describe in one impactful sentence the bigger purpose that this role contributes to in our company. **In this role, you have the opportunity to** Play vital role within Imaging System- the most profitable business as well as competitive and top in the marketing. Help potential customer […]

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