湖州招聘

职位描述：
 

1.Acts
as the China/Regional Lead for the designated global/regional studies and
assists the Senior Manager/Manager, Clinical Operations in the daily
operational matters related to the execution, management and monitoring of the
trials, such as review of informed consent forms, participating in site PSSVs,
co-monitoring visits, close-out visits, drafting of these visit reports, review
of IMP packages, etc. so as to ensure that the defined timelines and milestones
are being met in a timely and efficient manner.

2.Assists
the global/regional project teams to provide technical and content expertise
within China/Asia Pacific region during the course of the study, as well as identifying
potential challenges and working with team to strategize possible solutions.

3.Assists the Senior Manager/Manager
of Clinical Operations in CDD to enhance process, functional and operational
efficiencies in the clinical development of their designated global/regional
trials through sharing of information, best case examples etc. within CDD and
across the different PCUs

4.Provides general CRO/vendor
oversight in the management and progress of their designated global/regional
trials in China/Asia Pacific region

5.Participates in projects
and initiatives relating to better understanding of patient reality and hhc
within area of work

6.Assist in the improvement
of EPCS committees and processes, wherever possible.

Qualifications
and Expertise

· Working knowledge of entire drug development
process, including clinical plan development and execution of entire clinical
study chain, specifically within the China/Asia Pacific region

· Detailed knowledge of Code of Federal
regulations (CFRs), ICH guidelines, clinical operations, project management,
and corporate /regional SOPs

· Demonstrated ability to manage and coach
reports who are CRO project managers and individual contributors

· Good organizational, time management and
attention to detail skills

· Extremely proficient computer skills
including MS Word, Excel, and PowerPoint

Strong verbal,
written and interpersonal communication skills, especially needed to work
effectively in a cross-functional and cross-cultural team environment, managing
that team as required 举报 分享

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。