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Information Manager

Company Name:
Koch Davis
Supports the integration of labeling solutions into business processes. Liaises with business stakeholders and business technology groups to define or gather business requirements, defines new or improved business and support processes. Investigates solutions to business problems, and contributes to written materials that communicate solutions and/or options to relevant stakeholders resulting in appropriate decisions. Liaises with business stakeholders and business technology groups to provide/review impact assessments of business requirements and technical changes which include the identification of processes and applications, required changes to these processes and applications, and alternatives to mitigate impact. Supports utilization of RIM systems and processes by responding promptly to end-user inquiries. Assists business users in generating reports from labeling systems. Develops and executes ad hoc or standard queries and follow established procedures to validate queries/results in support of business requirements. Supports processes to ensure the quality of metadata associated with labeling systems. Leads small projects of short duration following established methodologies. Participates in system release activities. Participates in developing and performing user acceptance testing (UAT) as required. Participates in the development of training for labeling systems and collaborates with business lines to ensure a consistent approach and minimal overlap with business process-specific training. Supports a collaborative program of continuous improvement within the organization. Completes training in accordance with WSR regulatory information management curriculum, including information protection management Guidelines (IPMG) and 21 CFR Part 11 training requirements.
Requirements
3-5 years of relevant experience in data management with labeling and regulatory processes in the pharmaceutical industry, including an understanding of the drug development process. Experience with regulatory systems, databases, content management, tracking systems, business process management and electronic workflow/routing tools. Knowledge of safety, regulatory, and document management systems and technologies. Knowledge of application system management and change control processes, application validation (e.g., business user acceptance testing) and implementation in a GxP environment. Knowledge of pharmaceutical metadata and standards. Experience with and understanding of collaboration tools (e.g., SharePoint). Experience authoring business user requirements, business impact assessments. Experience conducting application testing activities. Experience with compliance frameworks and standard operating procedures. Experience with query tools/data extraction techniques (e.g., SQL, PL/SQL, Brio, MS Access) is desired.
Education
Bachelor degree/equivalent employment experience in life sciences, or information management related discipline required
Client
A multinational pharmaceutical corporation which develops and produces medicines and vaccines for a wide range of medical disciplines.

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