北京招聘

Role Description
Position TitleGovernance & Oversight Liaison
Division/OrganizationPfizer Medical / Worldwide Safety & Regulatory Operations (WSRO)
Line (i.e., Technology Infrastructure)Operational Excellence
Department (i.e., Application Hosting Services)Worldwide Safety & Regulatory Operations
LocationUS, UK, Asia
Predicted Grade(s)Range - P3 Manager / P4 Associate Director

Position Purpose
The Governance & Oversight Liaison (GOL) individual, operating as part of an integrated team has ultimate responsibility for the performance of Medical Documentation and Labeling (MDL) and Submission Management designated business processes across regions and between Pfizer and Vendors. The individual serves as a Pfizer expert in the end-to-end process adopting an integrated approach to continuous learning, proactive stewardship of key performance indicators, process development and guidance documentation. Through these responsibilities, this role plays a key part in improving and documenting year-on-year productivity levels across the MDL and Submissions organization.

The GOL ensures that feedback from concerned stakeholders (including Pfizer Country Offices, WRS HQ and WSRO labeling, authoring and submissions colleagues) is collated and assessed in the context of metrics available from systems monitored by WSRO Operational Excellence colleagues. Process optimizations emerging as a result will be discussed with the business line SMEs, Business Process Owner (BPO) and other stakeholders before implementation and communication of the changes.

The GOL ensures that the processes for document assignment and delivery are robust and responsive, and develops metrics targets for functional lines and Vendor to adhere to, in line with Pfizer service expectations. The GOL monitors customer satisfaction with the Vendor, proposing corrective actions to Management, and ensures that any agreed actions are fully implemented into Vendor processes in liaison with WSRO Strategic Sourcing and Procurement.

The GOL works closely with the WSRO Operational Excellence group when performing this work. Close collaboration with Worldwide Regulatory Strategy (WRS), and Worldwide Safety Strategy (WSS) functions both within and above country is also essential in gathering intelligence on process performance.

In summary this role is the enabling function for the BPO ensuring that designated business processes are developed and endorsed as appropriate.

Primary Responsibilities
Primary responsibilities include:
*Communicates and markets the process, sets goals with the BPO and initiates process improvements.
*Analysis and reporting of metrics on in-house and Vendor performance using data provided by vendors, WSRO and Pfizer Medical lines.
*Identify performance issues through analysis of metrics, and customer feedback (people, process and/or tool). Responsible for creating improvement actions, changes to processes, including updates to implemented guidance documents, and management of entire process improvement cycle to ensure performance effectiveness, with close collaboration from MDL and Submission Management SMEs and Business Process Owners.
*Subject Matter Expert on performance of processes underlying specified deliverables. Recognized throughout the organization as the spokesperson for liaison for designated vendors and both within-country and above-country Pfizer functions to ensure gathering of timely feedback to identify opportunities for process enhancement, and reporting of current performance metrics.
*Direct collection and analysis of metrics where these are not available via systems.

Technical Skill Requirements

*Knowledge of global/regional regulatory regulations and guidelines pertaining to WSRO deliverables
*Able to assimilate complicated issues, simplify them and make decisions
*Ability to negotiate with multiple stakeholders. Ability to work independently in a fast-moving environment
*Demonstrated ability to work with geographically diverse global teams and individuals
*Ability to understand, analyze, and interpret metrics and other performance measures, identify trends of concern, and link disparate issues through identification of common themes
*Knowledge of Continuous Improvement methodology is desired
*Fluency in English language important however multi-language skills are advantageous
*Strong written and verbal communication skills to ensure process improvements are effective

Resources Managed (budget and FTEs)

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。