Systems Specialist
PM
Systems Specialist
Poznań
Type of work
Undetermined
Experience
Mid
Employment Type
Permanent
Operating mode
Office
Tech stack
Agile
Analytics
Management
Job description
Online interview
We are looking for Systems Specialist who will ensure that GSK Regulatory Function maximizes the benefit from its investment in IT systems and business process development, by managing and optimizing the interaction between the Regulatory business groups and IT teams, both at GSK and vendors.
Key Responsibilities:
- Supports a varied portfolio of off the shelf and bespoke regulatory systems and platforms, that are used globally for the delivery and maintenance of regulatory activities.
- Provides first line support to global users
- Works under an agile framework to deliver value to the business in an iterative manner, including:
- Translation of business requirements into user stories
- Input to process impact analysis
- Gathering user feedback
- Supporting business validation testing (e.g. UAT & SATPs)
- Provide support to migration projects
- Contributes to development of project proposals and business cases.
- Provides and coordinates business engagement in projects in collaboration with IT and Business Project Teams.
- Input to training materials and reference guides.
Qualifications:
- Bachelor degree in relevant field (Science/IT)
- Experience in delivering business operational support to critical regulatory systems in a global environment (Regulatory Information Management and Reporting, Electronic Publishing and Validation Systems, Electronic Data Exchange and/or Labeling Management Systems).
- Software and System Experience (any of these): Veeva Vault RIM, Power Bi report analytic tool, CSC Regulatory Submission Suite - eCTDXpress, Publisher, Toolbox, Viewer, Global Submit Validate – Lorenz eValidator, Axway eSubmission Gateway – FDA Web Trader, EMA Gateway CESP.
- Led / participated in Business Change Teams, delivering IT solutions for the business.
- Extensive experience of working within a regulated project delivery environment.
- Good understanding of IT lifecycle, processes and quality management.
- Working in IT but with business facing knowledge or role e.g. business analysis, end user support.
- Ability to communicate and provide assistance and support on both sides of the Business-IT interface.
- Proven ability to interact effectively with senior managers within the organization.
- Experience managing change control and system lifecycle within a regulated environment, ideally in drug / vaccines development.
- Experience in Business Analysis and Business Process Design.
- Fluent communicator in English and local language.
- Ability to self-manage pieces and work and prioritize effectively.
- Service orientation, customer-focused.
- Good team-player.
- Result-driven, proactive, detail-oriented, problem solver.
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