长沙招聘

Reporting to: Solid line to Shanghai CPW Site Lead, China R&D Center (CRDC)

Dotted line to Head of Wuhan R&D Center (WRDC)

Zone / Line: Development Operations (DevOps), Pfizer Worldwide Research &Development (WRD)

Location: Biolake, Wuhan, Hubei (武汉光谷生物城)

Position Summary

The CPW Lead-Wuhan is responsible for leading the CPW group, through management and supervision of clinical programmers at Pfizer Wuhan R&D Center (WRDC) and oversight of vendors (CROs and FSPs) to whom these activities may be outsourced. The CPW Lead-Wuhan proactively manages resources across the CPW function and ensures effective collaborations with CPW groups at other sites in order to share resources flexibly to achieve optimal project support. The CPW Lead-Wuhan will develop and maintain strong links with other CPW Heads and Group Leads globally, and will work to align and motivate staff behind global Development Operations strategy. The role requires the development of strong working relationships with the other departmental functions, to facilitate open lines of communication regarding project priorities. The role has ultimate accountability for the delivery of CPW resources and services to meet goals associated with clinical study report sign-off.

Major Responsibility

• Provide supervision and leadership for CPW staff working across a number of clinical research projects.

• Be accountable for provision and proactive management of CPW resources across projects.

• Work with the CRDC Business Operations Head to plan and manage budgets and resourcing for clinical programming and writing activities at CRDC and at vendors.

• In collaboration with CRDC Business Operations Head, contribute to evaluation and selection of vendors providing services in the clinical programming and writing areas.

• Ensure that all staff fully understand the requirements of the job and are clear regarding the CPW deliverables for their protocol/project.

• Ensure development and implementation of site-specific change management based on worldwide strategies and standards; and in collaboration with other local functional heads.

• Ensure that all CPW activities are conducted in compliance with relevant regulatory requirements and SOPs. Ensure use of approved technologies that support the business goals.

• Implement strategies to ensure successful integration of global processes to ensure speed and quality in all CPW activities.

• Direct resources for the support of writing activities related to publication and other scientific reporting activities, as required.

• Develop and maintain strong links with other Dev Ops CPW group leaders and other functional lines to share best practices, identify areas for process and technology improvements, and develop and implement strategies to address these improvement opportunities.

• Work with CPW staff in the group to pro-actively identify problems on projects and help define solutions. Work supportively within global issue escalation process to ensure open discussion and positive learning. Support CPW staff in forming innovative options for their activities

• Administer and manage the CPW group in terms of contractual requirements, local HR issues, goals development, performance management, application of Pfizer policies / procedures and recruitment.

Training & Experience Requirement

• Post-graduate in statistics or computer science, or equivalent education/training is preferred.

• At least 5 years experience in programming or medical writing in the pharmaceutical industry / clinical research.

• Demonstrated leadership capability and substantive experience leading a team responsible for clinical study reports delivery (with programming), or membership of such a team and other team leadership experience.

• Clinical development and business experience in order to have a thorough understanding of the processes associated with delivering clinical study reports.

• Experience in oversight of vendors or contractors (CROs) performing clinical programming is preferred.

Competency Requirement

• Project management skills that can be used to facilitate efficient resource allocation and ensure adherence to timelines

• Excellent verbal and written communication skills in relating to stakeholders and colleagues; Good English language skills, both verbal and written

• Demonstrated ability to create clear written professional communications

• Excellent knowledge of drug development; Knowledge of methodology of clinical study, quality control, ICH guidelines and regulatory requirements,

• Knowledge / experience of statistical analysis, clinical study data analysis with SAS programming (desirable)

• Knowledge of medical writing (desirable), Experiences of clinical study conduct operation (desirable)

• Understands stakeholder needs and clinical project resource needs

• Strong customer service and consultative skills

• Ability to take a broad view of department operations and act proactively to optimize the department resources and preparedness for upcoming work

• Interacts effectively with a wide network of management, stakeholders, and colleagues across lines and sites, in a multi-cultural context

• Ability to provide leadership and management oversight, with particular emphasis on the ability to lead process development and improvement initiatives

• Proven ability to manage the performance of others to meet business objectives as well as colleague development / team development objectives and principles

简历收集邮箱：job-c2.china@pfizer.com

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。