长沙招聘

工作职责:

Position Purpose

Project manage and coordinate the compilation, submission ready quality control, request for sign-off, and post-approval compliance requirements associated with development of Pfizer global clinical study reports (CSRs)

Ensure timely delivery of Pfizer global CSRs for regulatory submissions or public disclosure requirements and ensure  compliance with regulatory guidelines, specifications, and Pfizer submission standards is achieved

Participate in process improvement activities to achieve operational excellence in clinical study report production

Primary Responsibilities

Project manage and coordinate compilation, quality control, approval and post-approval processes associated with development of Pfizer global CSRs, including:

Create CSR mockups in Pfizer Document Management System and populate document templates

Project manage CSR compilation, approval and publishing activities

Execute submission ready QC on CSR components and structure

Communicate with suppliers regarding issues with CSR components and seek resolutions

Seek approval from signatories on finalized CSRs and update clinical trial registry with CSR milestone status

Prepare investigator’s declaration packages for distribution to the coordinating investigator

Prepare study data packages required for distribution to study PIs

Generally:

Ensure all CSR activities are executed within agreed timelines and in accordance with working practices.

Proactively establish and follow clear priorities across portfolio of CSR workload to ensure the timely completion of CSRs contributing to a regulatory submission.

Where applicable, provide appropriate responses to any audit findings. 

Actively pursue training in technical and personal skills relevant to the CSR Coordinator role. 

Contribute to the achievement of departmental goals by ensuring that targets are incorporated into team and personal goals, and ensure that relevant metrics are collected so that functional line can monitor and address goals, targets and Submission Ready issues. 

In pursuit of maximum efficiency that addresses both speed and quality in document preparation across all therapeutic areas, assure that lessons learned are shared and applied across programs, and carry out established strategies to achieve continuous process improvement towards excellence in document management. 

Where appropriate, act as mentors to newly appointed CSR Coordinators

任职资格:

Technical Skill Requirements

Attention to detail and exceptional organizational skills

Proficiency in English language (read, written and spoken)

Track record of excellence in coordination skills

Experience in clinical study operations or regulatory operations preferred

Experience in project management preferred

Experience in electronic document management preferred

Experience in multinational company preferred

Qualifications (i.e., preferred education, experience, attributes)

Master or bachelor degree in biological, medical, or pharmaceutical sciences preferred  

#LI-PFE

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。