Site Name: Bengaluru Luxor North Tower
Posted Date: Jun 20 2024
Key Responsibilities
Provide operational support to GRC for Regulatory Systems
Support a varied portfolio of off the shelf and bespoke regulatory systems that are used globally for the delivery and maintenance of regulatory activities.
Provide first line support to global users
Interface with IT, Business System Owners to coordinate solutions delivery and support.
Contributing to development of project proposals and business cases.
Providing and coordinating the business engagement in projects in collaboration with IT and Business Project Teams.
Education Requirements
Minimum: Bachelor's Degree in IT / Science / Technical area of specialization
Reason: Working in complex technical environment within a scientific organization
Bachelor degree in scientific or technical area of specialization
Reason: The ability to interact confidently with highly-educated staff, customers and partners in a complex technical environment will be a significant advantage in this role
Job Related Experience
Experience 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).
Participate and Lead Business Change Teams delivering IT solutions for the business.
Solid foundation of working within a regulated project delivery environment.
Ability to communicate and provide assistance and support on both sides of the Business-IT interface.
Experience managing change control and system lifecycle within a regulated environment, ideally in drug / vaccines development.
Experience Business Analysis and Business Process Design.
It is essential that the candidate has experience of managing/supporting regulatory business IT systems (rather than just programming them). Some experience with business system ownership and business system lifecycle management.
Other Job-Related Skills
Fluent and able communicator in English.
Service orientation, customer-focused
Good team worker
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
Veeva Regulatory Vault
PowerBi
SharePoint
Why GSK
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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