Job Purpose :
This role will work across Business Performance and Compliance within Global Labelling to ensure labelling activities are monitored and managed in compliance with GSK policies and procedures, to leverage existing resources and sources of data to provide metrics for the efficient operational management of the Global Labelling functions and lead system and data administrative support for users of labelling systems. This role will design and manage data visualisation dashboards from regulatory tracking systems and databases in accordance with defined standards and processes to provide insights and analytics to stakeholders. This role is suitable for candidates who wish to develop skills in technology, systems, and digital data & analytics supporting the Global Labelling teams along with aligning to internal/external partners. This role is a business partner to the functional head, with responsibilities of developing, reporting, analysing, and presenting metrics across multiple business functions within Global Regulatory Affairs.
Key Responsibilities :
The information managed is critical to patient safety, regulatory compliance, and effective business operations. The role is accountable for the quality and accuracy of their own work and for the support of the substantial number of other users across GSK.
Responsibilities of this role are:
- Manage collection and analysis of performance & compliance data, report dissemination and follow-up for flagged events for labelling activities within an agreed schedule across global, regional, and local levels
- Support activities for the development, implementation, maintenance, and use of standards and processes to maximize quality and efficiency of continuous improvements
- Demonstrated project leadership skills managing several projects/activities at various stages of development
- Support various labelling systems and processes in accordance with GSK policies and procedures
- Leverage modern data visualization and analytics technologies to create dynamic business dashboards to effectively communicate and bring key insights to life for the business to improve visibility of key performance indicators (KPIs), resource tracking, compliance monitoring, and forecasting
- Collaborate with other GSK functions to ensure process consistency across teams and identify best practices, participate in forums for continuous improvement and present to stakeholders within GSK
- Proactively work with business services to identify areas for improvements to create efficiencies in labelling processes and use data analytics to propose solutions for effective decision making
- Accountable for the development, communication, and training of systems and tools within Global Labelling including delivery of high-quality analyses and metrics
- Support with functional groups with identifying root causes of deviations or ingredients of success
- Provide risk and issue management, mitigation services and compliance monitoring
- Produce and communicate service metrics and compile into monthly reports for distribution and escalation along with identifying trends, patterns and improvements using data
- Provide training, coaching, mentoring, and knowledge sharing within a dynamic environment for GSK Labelling and business partners
- Define automation and simplification initiatives with support from business partners to reduce manual/redundant processes, eliminate risks and drive continuous improvement
- Design new system functionalities and data requirements with support from system owners to meet business needs of Global Labelling and supported business partners
- Manage the development and maintenance of content for websites, GSK team sites, MS Teams, SharePoint lists, and other communication channels
- Understanding of system testing tools and procedures to work with Tech and Business System Owners on solution delivery and support, such as defining scripts for user acceptance testing (UAT), migration and training
- Support of requests from other functions, participate in project teams and activities as needed, and contribute to the implementation of changes to processes and systems
- Horizon scan to stay up to date with the latest technology, techniques, and methods available internally and externally
Education Requirements:
Minimum Level of Education
- Bachelor’s degree in business administration or life sciences field or related field that is appropriate to the function
Area of Specialisation
- Science / IT / Labelling or Regulatory Operations
Why is this Level of Education Required?
- Working in complex technical environment within a labelling/regulatory organization
- 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 :
- 2-6 years relevant experience (in pharmaceutical industry, life sciences research or regulatory operations, compliance, or labelling) 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).
- Consistent and accurate completion of data reporting, analysis, and follow-up tasks
- Ability to use adequate tools and systems to collate and report on appropriate performance measures for the business.
- High Attention to detail, significant experience with document and database management, excellent organization and time management skills, and a commitment to quality
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner with the ability to interact with various levels of management
- Ability to think flexibly to meet shifting priorities and timelines.
- Broad understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
- An understanding of labelling (e.g., through management of local labelling tracking and/or business performance systems and metrics).
- Ability and demonstrated performance working with GSK colleagues in areas of ambiguity.
Other Job-Related Skills:
Analytical skills:
- Good computer skills and proficient in Excel, Access, Word, Outlook, and PowerPoint
- Strong data analytical and problem-solving skills with a demonstrated ability to synthesize (source, consolidate and mine) data and extensively analyse data, trends and produce reports.
- Experience defining database modelling and design in combination with utilization of analytical tools (e.g. Power BI, Qlik, Tableau) to communicate appropriate information to target audience
- Ensure accuracy, completeness, timeliness, and reconciliation of data between multiple systems and databases.
- Ability to quickly assimilate facts and data of performance and compliance data to identify appropriate actions
- Ability to communicate complex matters with simplicity - persuasive with details and facts
- Good understanding database/data warehouse modelling and design
- Solid problem-solving with ability to challenge assumptions, drive change and improvement
- Understanding of the functional activities and drivers of performance in the assigned function
- Ability to translate processes, concepts, and strategies into measurable objectives
Project management & interpersonal skills:
- Good project management and facilitation abilities/experience
- Understanding and application of project and programme management concepts and techniques
- Ability to plan, coordinate, facilitate and executing projects
- Effectively manages interactions with Senior Stakeholders and Leadership Team
- Strategic thinking while recognizing and resolving local business needs.
- Experience in setting, managing, and tracking performance targets (activity to be performed by functional group, but assisted by this role)
- Adaptable to fast-paced environments with changing circumstances, direction, and strategy within a diverse organization
- Prioritize work requests and oversee project execution to ensure requirements are met, timelines are achieved, and customer needs are addressed
- Ability to think flexibly to meet shifting priorities and timelines.
Related Experience:
- Service orientation, customer-focused
- Excellent communications skills.
- Fluent and able communicator in English and able to communicate with users for whom English is not their primary language.
- Ability to work carefully under time constraints and prioritize accordingly within a matrix team environment
- Good team worker
- Awareness of Labelling & Quality systems and their criticality to internal standard operating procedures and legislative requirements
- Data visualization and data mining experience
- Experience using analytical tools such as Power BI or relevant applications
- Experience in training others in the use of tracking tools and reporting
- Proven experience in defining strategy and ensuring delivery of new and modified systems and processes for labelling compliance and/or tracking
- Direct or indirect experience of regulatory processes associated with management of labelling update information in validated regulatory systems
- Exposure to work within a regulated environment, ideally in drug / vaccines development.
- Regulatory document management experience
- Experience and familiarity of working within databases and MS team sites
Familiarity with entry, tracking and registration data management systems
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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