湖州招聘

Job Responsibility

- 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

- 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

- 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

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

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

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

Qulifications

- 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

Requirements

- 2-3 Years clinical research experience in a
pharmaceutical company and/or CRO in the capacity of a Project Lead / Project
Manager

- Experience
in handling multiple tasks and strong
personnel management experience

- Bachelor’s
degree required in associated scientific discipline, or Master’s
degree, PhD, or RN degree preferred

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。