上海招聘

Minimum Qualification of the QA Assistant QA Assistant任职要求

EXECUPHARM hereby represents and warrants that the QA Assistant has the relevant qualifications and capability to perform such monitoring service according to medical device regulatory requirements.

翼科在此声明并保证，根据医疗器械相关的法规要求，QA Assistant具备相关资质和能力来完成上述服务工作。

Services 服务

QA Assistant shall perform the following services:

QA Assistant须开展以下服务：

？ Translate the global documents, related records and reports

总部文件、相关记录及报告的翻译

？ Communicate and tracking the implementation of case (inquiry and complaint) handling requirements

协助沟通和跟踪各项事件(问询及投诉)处理要求在中国的执行

？ Communicate and tracking the implementation of Recall action in China Mkt.

协助跟踪召回行动在中国的执行进度。

？ Review the product quality compensation request

协助复核产品质量补偿申请

？ Documents & Records Management and Archive

相关文件及记录的整理和分类归档

？ MRA internal/external WeChat Management.

负责部门内外部微信公众号管理

？ Arrange classroom training for PMS topic.

负责上市后监管相关课程的现场培训安排。

COMPANY shall provide the necessary tools and assistance for the QA Assistant to perform the services as stated hereinabove. The required assistance from COMPANY includes but not limited to:

· Provision of project training e.g. process training, product training

提供项目培训，如流程培训、产品培训

· Overall supervision

全面监督

1. KEY TASKS/ACCOUNTABILITIES

？ Cooperate with related dept. to complete the assigned work and meet the Roche requirements.

积极主动与各相关部门合作，完成分派的工作任务，达到公司要求。

？ As a member of PMS team, provides active and strong process supports to internal department as needed

作为PMS团队的一分子，积极为各部门和内部员工提供及时和有力的上市后相关流程支持。

？ Initiatively deals with daily works. Keeps records. Has clear filing and maintain of all documents.

积极主动处理其他日常事务。做好工作记录。文件分类归档，保留完好。

？ Other projects or tasks assigned by line manager

其他主管指派的任务。

？ Conduct business in full compliance to Behavior in Business and Behavior in Competition

遵循商业行为准则，合理合法开展业务活动。

About ExecuPharm

ExecuPharm, A PAREXEL Company, is a Global Functional Service Contract Research Organization, who provides clinical research support services for the pharmaceutical industry. ExecuPharm’s distinctive business model incorporates flexible models of service and technologies to support every aspect of a clinical trial.

ExecuPharm, with a core management team with extensive clinical operations experience, understands clinical trial challenges and how to solve clinical outsourcing, staffing, placement, technology and process needs.
 
21+ years of Experience Meeting Client Needs
16,250+ Global Clinical Operational Specialists In Network
80% of Recruiting Staff with >15 Years of Experience
Talent Acquisition, Deployment Rates, and Employee Retention above 90%
Management Staff with Tangible Industry Experience
Greater Than 95% Repeat Business
Average Turnaround Time of 14 Days To Deploy Project Team Resources

 
Global Capabilities

ExecuPharm’s clinical operations specialists are well versed in country and regional customs, business practices as well as regulatory and ethical restrictions and considerations. Having a resource that knows the culture, speak the language and is close in proximity to trial sites will aid in resolving any issues pertaining to the trial in a fast and efficient manner. ExecuPharm global locations are as follows:
 
King of Prussia, Pennsylvania, United States - North America
Mexico City, Mexico - North America
Buenos Aries, Argentina - South America
Chichester, United Kingdom - Europe
Bangalore, India - Asia
Shanghai, China - Asia
Tokyo, Japan - Asia


Mission

ExecuPharm was founded with the goal to support the requirements of clinical studies for all pharmaceutical and biotech's around the world. ExecuPharm’s expertise in the placement of staff and the conduct and management of all phases of clinical research and full drug development is attributed to our operational efficiencies, transparency in our partnerships and effective, responsive client service. These core values take the everyday burden and challenges of clinical studies off the clinical team, management and all stakeholders involved leading to faster, more cost efficient execution of studies.
 

Timeline

ExecuPharm has grown organically and strategically since 1995
1995: ExecuPharm founded
2005: Expansion of core services to include functional outsourcing (FSP) recruitment for specific functional areas in clinical research
2006: Awarded trial management personnel augmentation program
2007: Awarded FSP for all trial management activities
2008/2009: Further developed clinical operations department, adding multiple senior leaders from midsized and major pharmaceutical companies Significantly expanded corporate infrastructure to increase capabilities in IT, HR, QA and Recruiting
Expanded functional outsourcing services to include monitoring and site management

2012: Expanded services, with offices, into Europe and Latin America
2013: Expanded services, with offices, into Japan, China, and India
2014: Expanded services, with offices, into Mexico
2016: Acquired by PAREXEL