长沙招聘

职位描述：
Primary Responsibilities
? Provide operational support to Hub Submission Manager(s) or equivalent roles within Submissions Management organization, execute designated tasks associated with submission coordination activities for assigned products and/or regulatory procedures as appropriate.
? Acountable for delivering quality and timeliness as per applicable policy, SOP/Work Instructions, guidelines or service level agreement.
? Command necessary knowledge and skills of regulatory submission and ensure regulatory or business requirements are fulfilled.
? Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
? Operate as Subject Matter Expert in dossier technical processes with responsibility for training and mentoring fellow colleagues.
? Escalate, inform, and/or resolve any issues that may impact timeline, quality or compliance of submissions.
? Commit to completing required on-the-job training courses to ensure training compliance is preserved.

Training & Education Preferred
? Degree in Pharmaceutical Sciences, Life Sciences, Business or Information Technology is preferred; equivalent relevant professional experience will be considered.
? Proven technical aptitude and ability to quickly learn and use new softwares or tools.
? Knowledge of drug development process and applicable regulatory guidelines.

Prior Experience Preferred
? Work experience in pharmaceutical industry.
? Experience of working in a challenging customer service environment.
? Demonstration of attention to detail.
? Solid experience and/or formal training in office tools.

Technical Competencies:
? Knowledge of the tasks performed by relevant lines in drug development, and the relative priorities and interdependencies
? Breadth of knowledge and experience with the utilization of variety of software applications and/or tools. Technical proficiency is a key competency for this role.

Behavioral Competencies:
? Works collaboratively with group members and contributes to positive intra- and inter-team relationships
? Looks for opportunities for collaboration and acts upon them
? Analyzes and solves problems to make effective decisions
? Able to foresee potential conflicts and problems related to schedule or resource needs and provide suitable solutions/options
? Seeks quality in all elements of the plans to provide high quality information and recommendations
? Responds to changing situations and others’ ideas that differ from own positively and constructively

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。