Programming TA Lead
辉瑞(中国)研究开发有限公司
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2015-03-26
- 工作地点:上海-浦东新区
- 招聘人数:若干
- 工作经验:五年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:面议
- 职位类别:生物工程/生物制药
职位描述
Primary Duties:
? Represents programming at TA/support area level
? Provides administrative and clinical programming technical and process oversight of TA group
? Performs duties of a Clinical Programmer as needed
? Is accountable for the implementation of clinical programming activities for studies and submissions related to the drug programs within each TA
? Manages team of Clinical Programmers to deliver clinical programming services in a high quality and timely manner, and within CPW metrics goals
? Develops new potential support area as required by Dev Ops initiatives
? Develops charters, resource utilization and project plans to achieve CPW specific goals
? Drives Therapeutic Area (TA) specific continuous improvement/innovations initiatives related to programming
? Actively oversees EPM project milestones and networks inconsistencies with stakeholders
? Ensures appropriate resources are identified to support the portfolio
? Ensures all clinical programming activities under remit conform to applicable standards, such as Pfizer clinical data standards, and are in compliance with relevant regulatory requirements
? Monitors and reports on implementation of functional area initiatives
? Develops aligned clinical programming strategies to ensure clear, transparent, consistent processes in strong collaboration with CRPM, DCAM,CDS, CTPQ, CII, and Alliance Partners
? Recognizes, initiates, and manages change that impacts the department/discipline
? Implements organizational design and develop succession planning for functional area in collaboration with other CPW Leads
? Develop people, including recruitment, retention, and career development and performance management
Training & Education Preferred:
? Minimum of a Bachelor’s Degree or equivalent in statistics, computer science, mathematical science or related discipline; Master’s Degree preferred
Prior Experience Preferred
? At least 8 years of relevant industry experience
? Proven experience leading a substantial group responsible for clinical programming and/or clinical writing function, or equivalent.
? Leadership, project management, resource management (staff and financial), administrative and technical capabilities are required, as well as effective verbal and written communication. Experience supporting the programming components of regulatory submissions required.
Technical Competencies:
Competency Detail / Comments (specific skills, etc.)
? Clinical programming experience.
? Ability to operate in a highly standardized environment.
? Project/process management.
? Clinical & regulatory processes.
? Scientific/administrative excellence.
? Systems technologies.
? Presentation/influencing/negotiation skills.
? Budget /expense management. ? Demonstrated knowledge and success in managing multiple clinical programs, and management technologies and processes.
? Thorough understanding of SAS, generic reporting systems, GDMS and Pfizer Data Standards.
? Demonstrated ability to manage complex projects and processes. Established history of timely and quality delivery.
? Demonstrated knowledge of clinical development and regulatory submission processes and requirements.
? Demonstrated success/results in prior scientific/administrative management roles.
? Knowledge/proficiency/understanding of technologies to support programming and/or writing, and software validation; understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.
? Demonstrated platform skills; experience presenting to large scientific audiences and non-science populations.
? Understands and has demonstrated ability to manage large and complex budget; history of staying on or under budget.
Behavioral Competencies:
Competency Detail / Comments (specific skills, etc.)
? Managing others/managing performance.
? Customer focus.
? Developing others.
? Innovation.
? Influencing.
? Networking and alliance building.
? Courage with decisiveness to act.
? Learning organization.
? Communication skills ? Makes strategic use of business data to monitor & raise performance.
? Establishes strong relationships with customers, strives to understand and meet customer requirements.
? Initiates career and succession planning to build and sustain longer term capability.
? Utilizes, encourages and shares innovative approaches to build and maintain a competitive advantage.
? Lobbies key internal and external stakeholders to ensure success.
? Looks for opportunities for collaboration and acts upon them.
? Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards.
? Develops a learning organization, encouraging experimentation, risk-taking, and development in all aspects of work performance.
? Strong listening skills with the ability to proactively define and manage required communication channels
? Represents programming at TA/support area level
? Provides administrative and clinical programming technical and process oversight of TA group
? Performs duties of a Clinical Programmer as needed
? Is accountable for the implementation of clinical programming activities for studies and submissions related to the drug programs within each TA
? Manages team of Clinical Programmers to deliver clinical programming services in a high quality and timely manner, and within CPW metrics goals
? Develops new potential support area as required by Dev Ops initiatives
? Develops charters, resource utilization and project plans to achieve CPW specific goals
? Drives Therapeutic Area (TA) specific continuous improvement/innovations initiatives related to programming
? Actively oversees EPM project milestones and networks inconsistencies with stakeholders
? Ensures appropriate resources are identified to support the portfolio
? Ensures all clinical programming activities under remit conform to applicable standards, such as Pfizer clinical data standards, and are in compliance with relevant regulatory requirements
? Monitors and reports on implementation of functional area initiatives
? Develops aligned clinical programming strategies to ensure clear, transparent, consistent processes in strong collaboration with CRPM, DCAM,CDS, CTPQ, CII, and Alliance Partners
? Recognizes, initiates, and manages change that impacts the department/discipline
? Implements organizational design and develop succession planning for functional area in collaboration with other CPW Leads
? Develop people, including recruitment, retention, and career development and performance management
Training & Education Preferred:
? Minimum of a Bachelor’s Degree or equivalent in statistics, computer science, mathematical science or related discipline; Master’s Degree preferred
Prior Experience Preferred
? At least 8 years of relevant industry experience
? Proven experience leading a substantial group responsible for clinical programming and/or clinical writing function, or equivalent.
? Leadership, project management, resource management (staff and financial), administrative and technical capabilities are required, as well as effective verbal and written communication. Experience supporting the programming components of regulatory submissions required.
Technical Competencies:
Competency Detail / Comments (specific skills, etc.)
? Clinical programming experience.
? Ability to operate in a highly standardized environment.
? Project/process management.
? Clinical & regulatory processes.
? Scientific/administrative excellence.
? Systems technologies.
? Presentation/influencing/negotiation skills.
? Budget /expense management. ? Demonstrated knowledge and success in managing multiple clinical programs, and management technologies and processes.
? Thorough understanding of SAS, generic reporting systems, GDMS and Pfizer Data Standards.
? Demonstrated ability to manage complex projects and processes. Established history of timely and quality delivery.
? Demonstrated knowledge of clinical development and regulatory submission processes and requirements.
? Demonstrated success/results in prior scientific/administrative management roles.
? Knowledge/proficiency/understanding of technologies to support programming and/or writing, and software validation; understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.
? Demonstrated platform skills; experience presenting to large scientific audiences and non-science populations.
? Understands and has demonstrated ability to manage large and complex budget; history of staying on or under budget.
Behavioral Competencies:
Competency Detail / Comments (specific skills, etc.)
? Managing others/managing performance.
? Customer focus.
? Developing others.
? Innovation.
? Influencing.
? Networking and alliance building.
? Courage with decisiveness to act.
? Learning organization.
? Communication skills ? Makes strategic use of business data to monitor & raise performance.
? Establishes strong relationships with customers, strives to understand and meet customer requirements.
? Initiates career and succession planning to build and sustain longer term capability.
? Utilizes, encourages and shares innovative approaches to build and maintain a competitive advantage.
? Lobbies key internal and external stakeholders to ensure success.
? Looks for opportunities for collaboration and acts upon them.
? Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards.
? Develops a learning organization, encouraging experimentation, risk-taking, and development in all aspects of work performance.
? Strong listening skills with the ability to proactively define and manage required communication channels
公司介绍
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。
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。
联系方式
- Email:ChinaCPWTalent@Pfizer.com
- 公司地址:1 (邮编:200000)