长沙招聘

职位描述：
工作职责
Organizational Relationship(s) including to whom the position reports (JD Job Title):
Publishing Team Manager or Publishing Team Lead

Position Purpose
This entry level role works within a team to provide pre- and after publishing support on Regulatory Agency Submission Packages (Dossier). The Dossiers are compiled in paper and/or electronic format with documentation received from submission coordinators and submitted to Regulatory agencies (often within very tight timeline) to seek clinical trial and/or marketing authorization approval for pharmaceutical products.



Primary Responsibilities
? Responsible for Dossier metadata entry via Pfizer submission management tool and system
? Responsible for pre-publishing Dossier preparation by documentation exporting, merging, splitting and format conversion
? Dossier archive post publishing and dispatch
? Other business needs to ensure publishing compliance

任职资格
Technical Skill Requirements
? In depth knowledge of drug development and regulation
? Fluent in English listening, reading, writing and speaking
? Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat
? Proven technical aptitude and ability to quick learn and use new soft wares, regulations and quality standards

Qualifications (i.e., preferred education, experience, attributes)
? Bachelor Degree (desirable) in Life Science, Business or Information Technology or other related fields
? Experience in pharmaceutical industry is a plus
? Ability to work with accuracy and attention to details
? Quick learner with ability to multi-tasks 举报 分享

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。