长沙招聘

Delivery of electronic and paper regulatory transactions and electronic review aids in support of post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.

 

 

 

Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. U.S. promotional activities, drug listing and establishment registrations, legalizations, and scheduled regulatory compliance reporting. 

 

 

 

Subject matter expert of Pfizer’s positions in support of proposed changes to CFR, Federal Register notices for rule changes as well as local process experts across organizational lines.

 

 

The role is responsible for coordination of information in support of New Drug Application Annual Reports. For all Pfizer approved products, the role have accountability  for sending annual report call for contributions to all functional lines, drafting regulatory docs, compilation contributions, facilitating creating regulatory agency submissions and oversighting on time deliveries to FDA. The role hold critical responsibility to ensure Pfizer maintains compliance for post marketing products.

 

 

 

Besides, the role also provides NDA AR labeling and PADER labeling contribution, including reporting most current USPI (labeling), artwork and action take related to safety reasons. The activity is to make sure all labeling changes are captured and reported to FDA in a certain period. The role also has the responsibility to search the artwork/USPI changes and work with drug listing team to make sure the newest artwork are effectively been published in Pfizer’s website and FDA, the National Library of Medicine (Daily Med) Website.

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。