长沙招聘

Position Title: Publishing Team Manager
Duration of Assignment:
(Permanent or Temporary) Permanent
Division/Organization:
(e.g., Pfizer Medical/ WSRO or WSS) Worldwide Safety & Regulatory Operations (WSRO)

Line:
(e.g., Quality Standards and Training) Information Management (IM)

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):
? Head IM PPLS China or Global Head PPLS

Position Purpose
To Manage publishing activities at the regional level ensuring that Pfizer delivers on key regulatory submission milestones and maintains compliance with applicable regulatory obligations.

At times of peak load across the organization, the incumbent is expected to publish submissions, and at all times will have comprehensive and detailed oversight of quality control and regulatory workload within their function.

Primary Responsibilities
? Ensuring successful portfolio delivery to designated health authorities to agreed time and quality standards. Managing the resources associated with compilation, publishing and delivery of all marketing applications that support new development projects and maintain regulatory compliance for investigational new drug applications and existing marketed product applications.

? Key Accountabilities:
?
? Direct and active supervision of a subgroup within Submissions, specifically focused on a subsection of the portfolio or type of specialist support to the business.
? Proactive liaison with remote customers within designated region to ensure streamlined product delivery
? Coordinates with remote/local peers to ensure compliance with local and global regulatory requirements
? Ensures that assigned projects/technologies relating to evolution of submission build, publishing and delivery processes and deliverables are carried out according to timelines
? Coordinates load balancing and resources at the respective site and in support of remote sites
? Develops ideas seeking efficiencies and effectiveness while managing the submissions portfolio
? Responsible for professional development through mentorship and motivation?

Technical Skill Requirements
? Understanding of the concepts around regulatory affairs and significant knowledge of submissions processes.
? Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor.
? Articulate with strong analytical and interpersonal skills
? Proven aptitude in project management and process redesign
? Proven ability to work successfully on global teams.?

Qualifications (i.e., preferred education, experience, attributes)
? Supervisory and publishing experience
? Master's or Undergraduate degree plus relevant experience
? Project Leadership
? Regulatory Expertise: Demonstrated knowledge of Regulatory submissions, code, guidance, specifications, and eCTD technologies.
? Communication Skills: Ability to communicate complex information and analyses to a variety of audiences in both verbal and written format.
? Technology: Experience with publishing software, XML, Document Management, regulatory milestone reporting tools
? Project Management skills : Mastery of processes, tools and techniques for planning and monitoring projects to established deadlines. Familiarity with pharmaceutical organizational structures, systems, and culture.

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。