长沙招聘

Responsibilities
-Proactively promote GCP compliance for clinical development activities to protect patient safety and wellbeing, maintain data integrity, and support operational excellence
-Drive risk management through issue identification and develop risk mitigation plans
-Facilitate ongoing quality improvement through reporting and communication of inspection findings, audit metrics and trends, quality visits, CAPAs, GCP guidance and consultation to clinical teams
-Collaborate with stakeholders to develop root cause analysis and implement corrective action plans to quality issues, audit and inspection findings. Ensure good working relationships with internal and external customer groups
-Train and educate Clinical Operations staff by the development and presentation of GCP and lessons learnt training courses
-Act as expert GCP consultant to groups within Eisai, CRO and investigational sites.
-Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)
-Conduct Inspection Readiness visits and Quality visits as necessary
-Support the CQA team in Clinical Investigator Site Audits, Vendor/System audits, Health Authority Inspection as assigned by Line manager
-May mentor new QI employee
-May serve as a member of industry association boards, task forces, and committees and / or as chairperson or officer of one or more professional associations. Contributes expertise to professional societies, academic, or other similar groups influential in his / her area of expertise
-Other duties as assigned

Requirements
-Bachelor's degree required with 5+ years relevant GCP experience (in roles including project management and trial monitoring site experience) including 1‐3 years of quality experience
-Experience of inspection management preferred
-Fundamental knowledge of China and international regulatory standards and guidelines for the conduct of clinical trials
-Strong analytical skills and report writing skills. Ability to speak, read and write English and Mandarin Chinese is mandatory
-Must have professional communications skills, strong independent time management skills and the ability to manage multiple tasks concurrently
-Able to work independently
-Ability to Travel (up to 20%). Primarily within China and occasionally to other countries in Asia Pacific

卫材在华企业隶属于卫材株式会社，卫材株式会社是一家以研究开发医药产品为主的跨国公司，总部设在日本东京。

卫材中国自上世纪90年代初进入中国市场以来顺利发展壮大。自1991年先后成立沈阳卫材制药有限公司和卫材（苏州）制药有限公司，并于2002年正式更名为卫材（中国）药业有限公司。伴随着中国业务的发展，于2010年成立卫材（苏州）贸易有限公司，于2014年成立卫材（中国）投资有限公司，并于2015年通过全额收购本地仿制药企业正式成立卫材（辽宁）制药有限公司。至此，形成了以卫材（中国）投资有限公司为资控管理，以卫材（中国）药业有限公司、卫材（辽宁）制药有限公司、卫材（苏州）贸易有限公司为业务支撑的发展模式。为适应中国业务的快速发展，2014年11月卫材（中国）药业有限公司注射剂工厂竣工， 2017年11月新固体制剂厂房落成，卫材中国的产能得到迅速提升。

目前，总注册资本10,854万美金。已形成以神经科学领域、肿瘤（特药）领域、消化肝病领域为重点领域，拓展仿制药领域，多达数十种药品在中国销售的发展规模。

未来，苏州工厂除满足中国患者临床用药的需求外，将向亚洲其它国家和地区同样提供高品质满足患者需求的产品。另外，卫材中国的销售额已连续十余年保持在华日资制药企业的***位置。

特别提醒：在候选人未正式入职前，卫材（中国）药业有限公司不会安排其参加任何培训，更不会向其收取任何费用，请应聘者谨防受骗。