上海招聘业务系统分析主管

业务系统分析主管

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：2019-04-05
工作地点：上海
招聘人数：1人
工作经验：3-4年经验
学历要求：本科
职位月薪：0.8-1万/月
职位类别：生物工程/生物制药技术支持/维护经理

职位描述

· Supports integration of content management solutions into business processes

· Investigates solutions to operations’ issues and develops or contributes to written materials that communicate solutions and/or options to relevant stakeholders resulting in appropriate decisions.

· Liaise with business and technical groups to define or gather business requirements, define new business and support processes or improve existing processes.

· Liaise with business and technical groups to review impact assessments of business requirements and technical change which include the identification of processes and applications, required changes to these processes and applications, and alternatives to mitigate impact.

· Ensures that the company’s critical information and records stored within COE–owned repositories are managed in accordance with external regulations and internal processes, are protected and controlled over the long term and that content is available for critical business needs and is retained in accordance with established retention schedules.

· Support advanced authoring solutions to simplify and improve document creation.

· Develop and execute ad hoc or standard queries and follow established procedures to validate queries/results in support of business requirements

· Gather metrics and generate standard reports regarding usage or support of IM systems

· Update master data or other standard configuration data elements within IM systems in accordance with standard operating procedures

· Participate in system release activities

· Contribute as appropriate to overall training program for content management systems and collaborate with business lines to ensure a consistent approach and minimal overlap with business process-specific training.

· Participate in development of solution test strategies and author/execute user acceptance testing during system releases to ensure high quality of Regulatory systems

Complete training in accordance with WSR Regulatory Information Management curriculum, including Information Protection Management Guidelines (IPMG) and 21 CFR Part 11 training requirements.
Gather integration requirements and source data
Responsible for facilitating small and medium projects from initiation to closure by working with internal (within Pfizer) and external teams
Document data mapping for integration of data for acquisition related projects
Proactively identify project issues and collaborate with the team to develop solutions
Perform data mapping from source to target systems

Technical Skill Requirements

· Training in current information management concepts and practices.

· Knowledge of document management practice and business processes in the pharmaceutical industry, including an understanding of the drug development process.

· Knowledge of document management systems, databases, business process management and electronic workflow/routing tools, regulatory submission and tracking systems.

· Knowledge of application system management and change control processes, application validation and implementation in a GxP environment

· Knowledge of Pharmaceutical metadata and standards

· Knowledge of Integration and business/industry work experience

· Experience with query tools/data extraction techniques (e.g., SQL, PL/SQL, Brio, MS_Access)

· Preferred Tools and Technologies: Document Management (e.g. GDMS)

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

· Minimum of 3 year document management experience and business processes in the pharmaceutical industry, including an understanding of the drug development process.

· Bachelor’s degree in Pharmaceutical, Biological, Information or Library Science (Master’s degree preferred). · In-depth knowledge with SQL, data management, reporting and query tools is a plus (e.g., SQL, PL/SQL, Brio, MS_Access)

· Experience with SAS or VB is a plus.

· Basic knowledge of Pharmaceutical drug development environment and regulations.

· Demonstrated customer relationship skills and capabilities and collaboration on teams.

· Demonstrated ability to perform in a cross-functional environment.

· Strong verbal, written communication and presentation skills.

· Ability to interact in a professional manner and build strong collaborative relationships with internal Pfizer teams. · Ability to interface with international colleagues, understand the “big picture” in terms of potential implications of changes to systems and processes to sites and/or affiliates outside of home country/region

· Strong project management and organizational skills

职能类别：生物工程/生物制药技术支持/维护经理

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。

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