长沙招聘

Version Date:
(dd-Mon-yyyy) 11-Dec-2012
Position Title: Publishing Manager

Duration of Assignment:
(Permanent or Temporary) Permanent
Division/Organization:
(e.g., Pfizer Medical/ WSR or WSS) Worldwide Safety & Regulatory (WSR)

Line:
(e.g., Quality Standards and Training) Submissions and Operations Support (SOS)

Department:
(e.g., Pharmacovigilance Quality Management) Publishing & Product License Support (PPLS)
Location(s):
(e.g., New London, Connecticut) Multiple

Organizational Relationship(s) including to whom the position reports (title):
? Publishing Team Manager

Position Purpose
This role works within a team to create Regulatory Agency Submission Packages (Dossier) using a number of build and publishing tools. The Dossiers are compiled in paper and/or electronic format with documentation received from Submission co-ordinators and submitted to Regulatory agencies (often within very tight timelines) to seek clinical trial and/or marketing authorization approval for pharmaceutical products.


Primary Responsibilities
? Responsible for the building, publishing, archiving activities and associated tasks for assigned Regulatory submissions within agreed timelines.
? Adhering to quality control procedures and standards related to submission publishing.
? Adhering to the appropriate use of document management systems, publishing and validation tools, through the use of working practices and quality control steps to ensure Regulatory compliance.
? Support other team members with submission workload when necessary to provide flexible support for the submissions portfolio.
? Support global/local teams by completing tasks assigned by submission co-ordinators
? Adhere to Pfizer compliance standards.

Technical Skill Requirements
? Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat.
? Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
? Functional and technical knowledge and skills to do the job at a high level of accomplishment

Qualifications (i.e., preferred education, experience, attributes)
? Proven technical aptitude
? Quick learner with ability to multi-task
? Ability to work with accuracy and attention to detail
? Ability to work with autonomy and/or part of a team in a busy environment
? Demonstrated ability to work in a highly regulated environment
? Demonstration of experience working in a customer service environment

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。