长沙招聘

工作职责:

Pfizer’s Expanded Access Program is within the Global Operations, Governance and Community/Worldwide Medical and Safety organizations. Expanded Access programs are treatment options that allow the use of IMP which under defined conditions, may be made available to patients who have exhausted all standard of care treatment and are not eligible for a clinical trial for a life-threatening or serious illness. The current program and processes follow CT16.

The Expanded Access Associate will provide operational support for the identified activities of the Expanded Access Program to ensure deliverables meet project goals.

ROLE RESPONSIBILITIES

Supporting Redaction Process for Expanded Access Requests with high quality.

Supporting CSDS and PfizerCAReS Metric Enhancement.

Supporting multiple Quality Check task as required.

Supporting the Expanded Access Team with PfizerCAReS data entries as required.

Contribute to special projects as required by the Expanded Access Team

任职资格:

QUALIFICATIONS

 BASIC QUALIFICATIONS

BA/BS degree required with preference for a focus in science, healthcare or related field.

Highly proficient in cloud-based technology databases and reporting browsers

Proficient in English; strong oral and written English communication skills are essential

Ability to utilize a technical platform to perform tasks and provide recommendations for improved business solutions

PREFERRED QUALIFICATIONS

Prior experience with Expanded Access programs preferred

Advanced degree (MS, MPH, RN) in life sciences or drug development required.

Demonstrated effectiveness working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change and diversity.

  

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。