长沙招聘

职位描述：
Position Purpose
To oversee and direct regional/national submission portfolio execution associated with ~40000 submissions worldwide to regulatory health authorities per annum, through leadership and engagement of Hub Submission Managers as part of a global business model.
Executes strategic direction, defines and upholds regional submission standards in support of new registrations and full product license lifecycle management to multiple regulatory authorities, maintaining compliance with applicable regulatory obligations while working to tight, business-critical deadlines within a highly regulated environment.
Accountable for managing submissions when required to meet business needs and at all times maintain a comprehensive and detailed oversight of process, quality control and regulatory workload within the function.
Proactive coordination of load balancing, resources and training in support of cross regional submission activity; assessment and monitoring of trends in portfolio activity that drive changes in operating model.
To represent Submissions Management as direct partner for WSR Country Regulatory Heads for designated markets and stakeholder management across partner lines.

Primary Responsibilities
Manager
? Partnership with peers ensuring quality and consistency of processes, directly supervising Hub Submission Managers to ensure Pfizer delivers on key regulatory submission milestones and maintains compliance with applicable regulatory obligations
? Responsible for balancing workload within and across regions and resource optimization in support of the global portfolio
? Drives and executes implementation of global submission policies and strategies to meet evolving business needs, achieving operational excellence through continuous improvement
? Develops and executes the optimization and harmonization of hub process to support the flexible resourcing model, ensuring portfolio execution meets time, quality and budgetary requirements
? Serves as a major source of innovative ideas seeking efficiencies and effectiveness and driving the implementation of technological solutions
? Understands, interprets and influences technical requirements for electronic Submissions as defined by FDA, EMA, MHLW, ICH and national markets
? Responsible for developing partnerships with country/regional leads and key stakeholders to ensure achievement of deliverables and identification of opportunities to gain greater efficiencies
? Responsible for professional development through mentorship and motivation.
? Responsible for hub adherence to internal standards and maintains a state of Inspection Readiness
? Provides guidance to and leads moderately complex submission and process improvement projects, making decisions independently
? Leads the interpretation of regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.
? Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Department
? Considered a technical resource within the group
? Matrix manages global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.

Senior Manager (cumulative from above)
? Drives communication and proposes refinements in the submissions process and related projects through collaboration with stakeholders and regulatory leaders
? Leads Lessons Learned sessions and implements change in partnership with Dossier Excellence Team
? Serves as Pfizer SM representative with Health Authority meetings, Industry discussions/ initiatives
? Accountable for changes in policies and strategies to meet evolving business needs
? Self-initiates assignments, developing innovative ideas to resolve complex problems and leading the execution of projects
? Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor
? Operates as delegate for SM leadership as required.

Technical Skill Requirements
Manager
? Demonstrated business acumen; strong organizational management skills, the ability to manage multiple demands simultaneously; the ability to respond to tight timelines in a highly regulated environment
? Strong knowledge of the drug development process, regulatory affairs, and submissions management; demonstrating an understanding of regional and national regulatory filing guidelines and dossier requirements
? Proven aptitude in project management and logistics
? Ability to work on multiple highly complex projects simultaneously; demonstrated attention to detail.
? In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
? Strong understanding of build and delivery of human health electronic and paper regulatory submissions and electronic review aids as defined by FDA, EMA, MHLW and ICH.
? Ability to operate seamlessly and influence direct and indirect reports, as well as across organizations.
? Ability to manage or deliver through others in a global operating model
? Ability to manage a significant and diverse portfolio of work with cross-site and line teams.
? Proven ability to embrace new technologies and drive their implementation
? Proven aptitude in project management and process re-design

Senior Manager (cumulative from above)
? Demonstrated business acumen; proven organizational management skills, and ability to manage multiple demands simultaneously; ability to respond to tight timelines in a highly regulated environment
? Significant knowledge of drug development process, regulatory affairs, and submissions management; demonstrating an understanding of regional and national regulatory filing guidelines and dossier requirements
? Ability to partner with Senior leaders in support of organizational objectives through strategic business planning
? Demonstrated ability to lead and deliver through others in a matrix model
? Demonstrated ability to deliver swift decision in ambiguous or urgent circumstances
? Advanced knowledge of the processes, systems and regulatory guidance and a detailed understanding/knowledge of principles and concepts of other disciplines
? Promotes peer relationships -can quickly find common ground and solve problems for the good of all; easily gains trust and support of peers; encourages collaboration.
? Uses a range of effective communication styles and creates and inclusive environment with internal/external stakeholders to deliver goals and promote quality; uses diplomacy and tact and can diffuse high-tension situations comfortably.

Qualifications (i.e., preferred education, experience, attributes)
? B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
? Proven aptitude in project management and process redesign
? Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
? Demonstrated excellence in interpersonal (verbal and written) skills
? Ability to successfully establish and build collaborative relationships with colleagues within and across an organization
? Demonstrated leadership and flexibility in dealing with change and diversity as part of a global team
? Experience in resource management in a professional & dynamic environment
? Multi-lingual skills desirable.
? Familiarity with pharmaceutical organizational structures, systems, and culture is preferred 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。