长沙招聘

职位描述：
Delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, Legalizations, Promotional Materials and 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.
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? Key Accountabilities:
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? Delivery of Product License Support Portfolio
? Solution implementation of solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes.
? Knowledge share and educate personnel as appropriate on agency requirements and guidelines.
? Lead or participation on global/local teams to complete assignments and tasks within a specific task force/project.
? Process development and change management in the context of PLS submissions
? liaison with internal stakeholders for issues regarding standards and processes, and drives resolution of these
? utilization support of electronic technologies for submissions and tracking of documentation
? Matrix management of cross-functional teams as appropriate
? Development and maintenance of documented procedures and guidelines as necessary

Technical Skill Requirements
? Demonstrated knowledge of CFR as it relates to specific post-market submissions for Drug Listing and DDMAC divisions at FDA
? Demonstrated knowledge of/experience with Pfizer Commercial Portfolio
? Ability to communicate complex information and analyses to a variety of audiences in both verbal and written format
? Demonstration of processes, tools and techniques for planning and monitoring multiple projects to established deadlines
? Demonstrated ability to work with or lead a team in a matrix structure
? Global perspective within the context of business needs and impact

Qualifications (i.e., preferred education, experience, attributes)
? Undergraduate degree plus relevant experience as below, or
? Demonstrated fluency with regulatory submissions publishing and understanding of application of technologies.
? Demonstrated ability to function autonomously in a matrixed environment.
? Regulatory Expertise: Demonstrated knowledge of Regulatory compliance requirements, processes and systems
? Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
? Technology: Experience and competency with Regulatory software, XML, Document Management, regulatory milestone reporting tools.

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。