Regulatory Specialist, Labelling Business Performance

Job title:

Regulatory Specialist, Labelling Business Performance

Company:

GlaxoSmithKline

Job description

Regulatory Specialist, Labelling Business PerformanceThis role will work across Business Performance and Compliance within GSK Labelling to ensure labelling activities are monitored and managed in compliance with GSK policies and procedures, to leverage sources of data to provide metrics for the efficient operational management of the GSK Labelling functions and provide system and data administrative support for users of labelling systems.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.

Qualifications & Skills

• Bachelor’s degree (or higher) in business administration or life sciences field or related field that is appropriate to the function
• Several years relevant experience (in pharmaceutical industry, life sciences research or regulatory) delivering business operational support to critical business systems in a global environment
• 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
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes
• 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

We offer

• Career at one of the leading global healthcare companies
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible counterparts
• Long-term incentives
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure
• Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
• Extensive support of work-life balance (flexible working solutions, short Fridays option, health & well-being activities)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits everyday
• Free car and bike parking, locker rooms and showers

We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team ( ) to further discuss this today.#LI-GSK#LI-HYBRID#LI-DEIWhy 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.GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at

Expected salary

Location

Poznań, wielkopolskie

Job date

Sun, 02 Feb 2025 01:19:43 GMT

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