长沙招聘

职位描述：
Position Purpose
To Manage and oversight one or multiple PPLS activities including IIP, Product License Support, CSR, submission coordination and publishing at global/regional level ensuring that Pfizer delivers on key regulatory submission milestones and maintains compliance with applicable regulatory obligations.


Primary Responsibilities
Ensuring successful portfolio delivery to designated health authorities within agreed time and quality standards. Managing the resources associated to delivery all marketing applications that support new development projects and maintain regulatory compliance for i***estigational new drug applications and existing marketed product applications.

Key Accountabilities:
? Direct and active supervision of subgroup(s) within organization, specifically focused on one or multiple subsections to provide portfolio support on business
? Proactive liaison with remote customers globally or within designated region to ensure streamlined product delivery
? Coordinates with remote/local peers to ensure compliance with local and global regulatory requirements
? Initiate and execute assigned projects/technologies relating to capability evolution and deliverables are carried out according to timelines
? Closely team/function oversight and continue seeking efficiencies and effectiveness to achieve regulatory operational excellence
? Proactively explore business opportunity internally or externally for capability extension and enrichment
? Responsible for professional development through mentorship and motivation

Technical Skill Requirements
? Deep understanding of the concepts around regulatory affairs and significant knowledge from clinical study to post market approval
? Proven ability to work successfully on global teams; works collaboratively with peers and contributes to positive intra- and inter- team relationships both locally and global
? Functions as a change agent, demonstrated ability to initiate, take and adapt to new processes, responsibilities and organizational changes; positive attitude and proactively manage changes by identifying opportunities and coaching self and others through change
? Proven aptitude in project management and process redesign, need experience with successful delivering projects to appropriate decision points and be able to resolve conflicts effectively and win-win for all parties
? Strong interpersonal skills, be able to communicate effectively and appropriately with staff at widely differing levels in organization and internal/external stakeholders
? Innovation and continuing improvement spirit by exploring, implementing and utilizing novel to complex methodologies to build and maintain competitive advantages


Qualifications (i.e., preferred education, experience, attributes)
? Master with 5+ year experience or bachelor with 8+ year experience in pharmaceutical industry, be familiar with pharmaceutical organizational structures, systems and culture
? Fluent and skillful Mandarin and English, ability to communication complex and analysis to a variety of audience in both verbal and written format
? Leadership with successful team supervisory experience and excellent people management skills
? Project management skills to own processes, tools and techniques for planning, executing and monitoring progress to established deadlines; demonstrated ability working in a matrix team
? Solution oriented and be able to handle different types of responsibilities and multi-task efficiently
? Thorough knowledge on clinical study report, regulatory submissions, codes, guidance, specifications or eCTD technologies
? Experiences with publishing software, XML, document management, regulatory milestone reporting tools; strong computer skills 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。