• 1年经验
  • 本科
  • 招1人
  • 02-24 发布

职位描述

1. Ensure clinical supply work to be carried out according to current regulations, guidelines, company procedures and project specific supply plans.2. Collaborate with external and internal stakeholders to reach alignment on project key milestones and track project progress against plans.3. Work with MRL supply team to plan and manage investigational supplies for local clinical trials within targeted budget and timeline. 4. Work with finance team to support supply budget, spending and tracking payment. 5. Collaborate with regulatory, procurement, supply chain and other related functions to support drug import application.6. Work with procurement team for supply purchase related issues.7. Work with clinical operation team to ensure trials normal operation.8. Responsible or support for warehouse management.9. Manage directly or via appropriately selected contractors for clinical supply purchase, import, package, storage, dispatch, return and destruction. Generate study specific agreements and work orders and arrange procurement of the study medication.10. Work closely with drug and ancillary supply distribution, IVRS/IRT and label translation vendors during the set up and maintenance of related logistics.11. Timely complete project-related documentation in accordance with SOP, GMP, national regulations and other relevant codes of practice. 12. Support on developing tools, SOPs, working instructions and training materials for clinical supplies.13. Support or deliver project-based or internal trainings to external functions or new team member orientation. 14. Support supply lead for any task request.任职资格:1. All clinical supply activities are in compliance with related regulations and internal procedures.2. Well plan and manage investigational supplies for local clinical trials within targeted budget and timeline.3. Track per shipment form related with inventory report and temperature report to make sure each trial supply delivery on time.4. All supply related documents are timely and appropriately archived.5. Monitor the reports generated by the IVRS system on an ongoing basis, and ensure that all warehouse and investigator sites to have sufficient stock. 6. Proactively identify quality issues and take timely actions to ensure study result accuracy and integrity even with high challenges.7. Have regular vendor meetings with clear meeting minutes and action plan/follow up. Have adequate tracking plan and timely implementation with clear record and CAPA.8.others:Bachelor or above degree in medicine/ pharmacology or logistic management At least 1 year in relevant area Good command of English, both in verbal and in writtenexperience 职能类别: 生物工程/生物制药 药品生产/质量管理 关键字: 医学 药品

联系方式

北京市建国门外大街中环世贸中心

公司信息

萌蒂(中国)制药有限公司(以下简称“萌蒂中国制药”),自1993年进入中国以来,始终专注在疼痛领域的规范化治疗理念的推广和产品研发与生产。目前,萌蒂中国制药是国内一家专业研发生产和推广镇痛药的跨国公司,在华拥有1500多位员工,业务遍布300多个城市。在北京拥有设备先进、国内的专业麻醉和精神类药品的生产工厂。 通过多年的不懈努力,萌蒂中国制药已成为中国癌痛领域当之无愧的领导者,并引领镇痛领域。 多年来,我们一直坚持为提高人类的生活质量和健康水平而奋斗,“健康生活,品质人生”是我们的企业愿景;关爱生命,回馈社会是我们的社会责任;创新的天赋,以患者为核心的理念以及企业家精神是我们血液中的 DNA。 未来,萌蒂中国制药将继续深耕疼痛管理领域,同时将业务进一步拓展至肿瘤、消毒用品、呼吸系统、健康消费品等全新领域。 更多公司信息,请参阅 http://www.mundipharma.com.cn

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