Regulatory Specialist, Labelling Business Performance

Key Responsibilities -

• Coordinate data collection for performance & compliance metrics, report dissemination and follow-up for flagged events related to labelling activities within an agreed schedule across global, regional, and local levels
• Assist with activities for the development, implementation, maintenance, and use of standards and processes to maximize quality and efficiency of continuous improvements
• Provide support with building tools and defining processes for data analytics, modelling, transformation, integration, reporting etc. on business data to improve visibility of key performance indicators (KPIs), resource tracking, compliance monitoring, and forecasting
• Confirm accuracy of metrics, compile monthly reports, and escalate of risks and variances when appropriate
• Assist with development and maintenance of content for websites, GSK team sites, MS Teams, SharePoint lists, and other communication channels
• Work with functional groups to recognize trends, patterns and improvements using data along with identifying root causes of deviations, or ingredients of success
• Contribute to automation and simplification initiatives to reduce manual/redundant processes, eliminate risks, and drive continuous improvement
• Support labelling systems with training of global and local users in accordance with GSK policies and procedures
• Understanding of system testing tools and procedures to work with Tech and Business System Owners on solution delivery and support, such as the participation in user acceptance testing (UAT), migration and training
• Support assignments for new system functionalities and data requirements to meet business needs of GSK Labelling and supported business partners
• Horizon scan to stay up to date with the latest technology, techniques, and methods available internally and externally

Analytical skills -

• Good computer skills and proficient in Excel, Word, Access, Outlook, and PowerPoint
• Strong data analytical and problem-solving skills with the ability to synthesize (source, consolidate and mine) data and extensively analyse data, trends and produce reports. 
• Understanding database modelling and design in combination with utilization of analytical tools (e.g. Power BI, Qlik, Tableau) to communicate appropriate information to target audience Support activities for accuracy, completeness, timeliness, and reconciliation of data between multiple systems and databases.
• Ability to quickly assimilate facts and data
• Ability to communicate complex matters with simplicity - persuasive with details and facts
• 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 -

• Some project management and facilitation abilities/ experience
• Adaptable to fast-paced environments with changing circumstances, direction, and strategy within a diverse organization.
• Knowledge of project and programme management concepts and techniques
• Ability to plan, coordinate, facilitate and executing projects
• 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
• Good team worker
• Awareness of Labelling & Quality systems and their criticality to internal standard operating procedures and legislative requirements
• Data mining experience
• 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

Mandatory skills -

• 2-3 years 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)
• 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 and compliance 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
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes

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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