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Technical Supervisor, IM


Shanghai City, IL 61412
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Job Details

Business Support and Analyst role for Pfizer's R&D content management/authoring application and systems.(GDMS, pTMF, etc)Position Purpose

Individuals filling the position listed are responsible for providing subject matter expertise in the management of the enterprise content management applications as well as associated change management and support activities for the Information Management, Operations Center of Excellence Content Management and Authoring system portfolio. Incumbent will partner with Business Technology and business lines to ensure timely system(s) data integrity and compliance.

Primary Responsibilities

+ 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)


+ 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).

+ 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

N: Not Applicable - (China)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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