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Senior Information Manager

Individuals filling the position listed are responsible and leading medium to large scale information management projects to drive support efficiency and value as well and support activities for the Regulatory Solutions portfolio.  Incumbent will partner with Business Technology and business lines to ensure robust solutions and data integrity. ROLE RESPONSIBILITIES Support integration of regulatory solutions into business processes Establish continuous improvement program to analyze support data for root cause and lead continuous improvement solutions to provide more effective support Establish stakeholder management plans across stakeholders of our solutions. Define and lead customer engagement initiatives to identify voice of the customer feedback Provide direction to other regulatory solutions team members on support-oriented projects Deliver solutions to customer issues and develop materials that communicate solutions and/or options to relevant stakeholders resulting in appropriate decisions.  Coordinate with regulatory business including - safety, regulatory, operations and technical groups to define or gather business requirements, define new business and support processes or improve existing processes. Coordinate with business and technical groups to provide/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. Lead continuous improvement projects to simplify and improve system use and system management. Establish and gather metrics and generate standard reports regarding usage or support of IM systems Lead medium to large projects with a medium length duration, following established methodologies Define system training strategy across our solutions and lead system training program for regulatory solutions and collaborate with business lines to ensure a consistent approach with business process-specific training. Participate in and lead medium to large quality oriented projects intended to ensure high quality data in our regulatory systems BASIC QUALIFICATIONS BS/MS in Computer Science, Life Sciences, Business, engineering, statistics or a related discipline Minimum 7 years pharmaceutical industry experience in (or supporting) any of the following disciplines: clinical drug development, clinical trial management, safety surveillance and reporting, clinical project management, R&D or regulatory reporting and analytics, or regulatory affairs. Related experience in other industries will be considered. Demonstrated strong analytical skills with demonstrated ability to investigate and solve problems Demonstrated Knowledge of application system management and change control processes, application validation and implementation in a GxP environment. Demonstrated strong customer relationship skills and capabilities to collaborate with teams. Proven ability to communicate complex information and analyses to a variety of audiences in both verbal and written format. PREFERRED Minimum of 5+ years of project and/or program management experience Graduate degree A comprehensive understanding of data and systems used in the R&D processes. Proven technical aptitude with software used in Regulatory (for example tracking, document management, submission publishing tools). Experience with query tools/data extraction techniques (e.g., SQL, PL/SQL, Brio, MS_Access) is a plus. 4724104
Salary Range: NA
Minimum Qualification
8 - 10 years

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