Full Job Description
Job Purpose:
To ensure that the GSK Pharmaceuticals Regulatory Function maximizes the benefit it gets 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:
Provide operational support and strategic direction to GRPD for Regulatory Systems
Deliver and lead the ownership and business support for a varied portfolio of off the shelf and bespoke regulatory systems that are used globally for the delivery and maintenance of regulatory activities.
Manage business, project and support challenges globally
Lead the interface with IT, Business System Owners to coordinate solutions delivery and support.
Develop project proposals and business cases to address the tactical and strategic needs of the business.
Lead the business engagement in projects in collaboration with IT and Business Project Teams.
Basic Qualifications:
Bachelors degree in Area of Specialization like IT / Science / Technical.
Preferred Qualifications:
Master’s degree in Scientific or technical
Significant experience delivering business operational support and strategic direction for 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).
Lead Business Change Teams delivering IT solutions for the business.
Expert in experience working within a regulated project delivery environment including standard GSK change control and validation procedures.
Drive support assistance and support on both sides of the Business-IT interface.
Significant experience managing system ownership including change control and system lifecycle management within a regulated environment, ideally in drug / vaccines development.
Experience developing solution based on business analysis needs and external drivers.
Fluent and able communicator in English and local language
Service orientation, customer-focused, Protection of Enterprise
Ability to take accountability and ownership of
Team Leader
Software and System Experience (any)
Parexel Insight Manager – RIM and Cognos Reporting
Documentum D2 – Labeling System
CSC Regulatory Submission Suite (eCTDXpress, Publisher, Toolbox, Viewer)
Global Submit Validate – Lorenz eValidator
Axway eSubmission Gateway – FDA Web Trader, EMA Gateway CESP
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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