长沙招聘

工作职责:

Position Purpose

Provides an interface to Regulatory and GPD partners within designated Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory CTA submissions to regional partners and selected Health Authorities.

The CTA Submission Manager (CTA-SM) is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs. They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components. The CTA-SM may be assigned as a Hub Submission Manager to meet business demands. In this capacity, they may operate as Subject Matter Expert for a selected geography.

Primary Responsibilities

Manager

？ Drives global submission management activities for their assigned assets. Partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables associated with CTA submission development and execution for designated assets and/or geographies.

？ Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities

？ Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.

？ Liaises with Study Management, regarding essential core documents that cross both HA and EC submission and translation processes

？ Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.

？ Responsible for the co-ordination of translations for core documents required for submission

？ Manages the compilation for core package build, contributing to CTA and authoring documentation as required

？ Acts as Subject Matter Expert for Regulatory Operations and provides country-level intelligence on clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the CTR team, is maintained on the central repository, e.g., Competent Authority submission requirements

？ Coordinates submission production and assists with definition, development, and

implementation of global submissions policies and technologies to meet evolving business needs.

？ Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

？ Serves as a major source of innovative ideas seeking and developing efficiencies and effectiveness within the Submissions process by collaboration with key customer and supplier groups and business partners,

？ Promotes professional development through mentoring and motivating colleagues.

？ Drives connectivity and implements refinements in the Emerging Markets partner model through collaboration with peers

？ Promotes the use of Document Management and Archival systems and standard document authoring, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.

？ Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor

？ Operates as single BU Liaison point of contact for Regional Regulatory Leads and designated CTAs.

？ Leads the interpretation of dossier requirements to produce business processes and ensure that those processes are implemented where appropriate at global and local level.

？ Manages own time to meet objectives; forecasts and plans resource requirements

(people, financial and technology) for projects across Department

？ Provides guidance to and leads CTA submissions and process improvement projects, making decisions independently

？ Considered a technical resource within the group

Senior Manager (cumulative from above)

？

Drives communication and proposes refinements in the Emerging Markets partner model 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

？ Contributes to changes in policies and strategies to meet evolving business needs

？ Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor

？ Self-initiates assignments, developing innovative ideas to resolve complex problems and leading the execution of projects

Operates as delegate for SM leadership as required.

任职资格:

Technical Skill Requirements

Manager (qualitative examples)

？ Proven aptitude in leadership, problem solving and logistics

？ Ability to work on multiple highly complex projects simultaneously.

？ Demonstrated attention to detail.

？ Strong knowledge of the drug development process, regulatory affairs, Clinical Trial Applications and submissions management.

？ 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.

？ Ability to operate seamlessly and influence direct and indirect reports, as well as across organizations.

Senior Manager (qualitative examples)

？ Significant knowledge of the drug development process, Regulatory Affairs and submissions management.

？ Demonstrated understanding of regional and national regulator filing guidelines and dossier requirements.

？ Demonstrated ability to lead and deliver through others in a matrix model

？ Demonstrated ability to deliver swift decision in ambiguous or urgent circumstances

？ Robust organizational management skills

？ Advanced knowledge of the processes, systems and regulatory guidance and a detailed understanding/knowledge of principles and concepts of other disciplines

？ Proven ability to embrace new technologies and processes and drive their implementation

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.

？ In-depth understanding and proven execution of CTA processes globally

？ Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards

？ Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive

？ Understanding of EU Clinical Trial Regulation Desirable

？ Familiarity with pharmaceutical organizational structures, systems, and culture is preferred

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。