At GSK, we’re constantly developing new products and improving our established medicines to improve the quality of human life by enabling people to do more, feel better and live longer.
Ensuring these products are correctly prescribed and used is essential, and that’s where our labelling team is key. The Labelling team supports our portfolio of medicines by ensuring that the information relating to the safety and efficacy of our products reaches patients and prescribers.
GSK currently has opportunities in its Global Regulatory Affairs (GRA) - Labelling department. This role is perfectly suited for enthusiastic IT or regulatory professionals with experience or an interest in patient and prescriber information and who would like to pursue a career in a global pharmaceutical company.
Our Labelling team supports a product during development and throughout its lifecycle. In your role as Senior Regulatory Specialist, Labelling Business Performance you will work with the Labelling Business Performance Teams within Global Labelling to ensure that labelling updates are monitored and managed in compliance with GSK procedures, to leverage existing resources and sources of data to provide metrics for the efficient operational management of the Global Labelling functions, and provide system and data administrative support for users of labelling systems.
You will be responsible for effective development, management, reporting and analyses of regulatory tracking systems and data in accordance with defined standards and processes.
This role will provide YOU the opportunity to lead key activities to progress YOUR career.
These responsibilities include some of the following
Lead development of tools and processes for managing baseline data, resource tracking and forecastingCoordinate and manage data collection and reporting process for compliance with timelines and for delivery of labelling updates with partners at global, regional and local levelsSupport the Labelling management team with reports to address performance queries (related to source data) and work with functional groups to identify root causes of deviations, or ingredients of successSupport labelling systems with system administration, including training of global and local users in accordance with GSK policies and procedures
Support Global Labelling teams to improve visibility and access to performance and workload data
Work closely with IT, Business System Owners to coordinate solution delivery, system validation and support
Support development and maintenance of labelling websites, Team Sites and other communication channels
Support labelling functions and participate in other projects and activities as needed, such as contributing to the implementation of changes to processes within GRA Labelling.
Subject Matter Expert in labelling tracking systems.
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals :
Bachelor’s degree in business administration or life sciences field or related field that is appropriate to the function
Relevant experience (in pharmaceutical industry, life sciences research or regulatory) delivering business operational support to critical business systems in a global environment
Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research or regulatory
Regulatory Technology experience (Document / Content Management / RIMS / Veeva Vault) including administration
Data visualization experience
Proven experience in defining strategy and ensuring delivery of new and modified systems and processes for labelling compliance and / or tracking
Ability to work carefully under time constraints and prioritize accordingly within a matrix team environment
Excellent written and verbal communication skills in English and ability to present information in a clear and concise manner
Ability to think flexibly in order to meet shifting priorities and timelines