上海招聘

位概述 Job Summary :

1.   Establishes and maintains the good and closed relationship with SFDA testing centers. And successfully gains product registration certificates per registration forecast plan. 和全国各 SFDA 检测中心保持良好关系,依据公司产品上市计划及时取得进口产品注册检测报告。

2.   Establishes and maintains the good and closed relationship with hospital IVD departments (clinical Lab, drug monitoring lab, GCP, etc...). And builds up and represents Roche Diagnostics’ good image, and gain products clinical trial reports per action plan. 建立并保持与 IVD 临床机构(检验科,药剂科,药理基地 等)的良好关系,树立公司形象,并及时取得临床试验报告。

3.   Monitors and reports on local regulation changes and its impact together to company. Assists manager to handle daily work in Regulatory Dep.将信息和政策导向及时通知公司。协助经理处理日常法规问题

主要工作职责 Main Tasks & Responsibilities :

1.   Works with sales and marketing dep. to fulfill product registration plan. Achieves RD expectation on product registration.与销售和市场部配合,完成注册计划。达到公司对产品注册的要求。

2.   Establishes and maintains the good relationship with key contacts. Recommends valuable suggestion to company 建立并保持与政府部门及重点客户的良好关系,为公司提供有价值的意见。

3.   As a member of RD, provides active and strong regulatory supports to internal dep. as needed. 作为团队的一分子,积极为各部门和内部员工提供及时和有力的政策法规的支持。

4.   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法规问题。做好工作记录。文件分类归档,保留完好。

5.   Other projects or tasks assigned by line manager

主管指派的其他任务6. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in

Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection

遵循罗氏所有合规要求,包括但不限于罗氏信息安全,罗氏商业中的行为,罗氏竞争法互动对话,罗氏安全健康环境等,合法合理开展业务活动

Bachelor degree or above, subject on Medical/bioengineering/ clinical Medicine or biochemistry .

大学本科以上学历,医学/ 生物工程/ 临床或生化专业.

工作 经验 Experience :

1.   Have not less than 2 years about experience in medical regulatory affairs, focus on testing center and clinical trial. Understand IVD products’ Standard like industry and national standards( YY and GB)有 2 年以上医学法规领域的经验 ,有检测和临床经验优先。 了解 IVD 产品标准(行业和国家标准)。

2.   High enthusiasm and devotion, work hard and earnest 具有强烈的事业心,工作仔细认真。

3.   Willing to work under pressure, self-starting and self-inspiring 能承受高强度的工作压力,积极主动

并自我激励。4. Be honest and open, excellent interpersonal communication skill, ability of social activity and

  

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