Senior Specialist, Reporting and Analytics

The Global Regulatory Operations Reporting Senior Specialist at GlaxoSmithKline (GSK) is responsible for development, implementation, and maintenance of reporting services that support regulatory operations on a global scale. This role ensures the delivery of high-quality, compliant, and timely regulatory reports that meet the business needs and regulatory requirements across various regions. The manager collaborates with cross-functional teams, including Regulatory Affairs, IT, Quality, and other stakeholders, to drive continuous improvement in reporting processes and data integrity. By leveraging advanced analytics and innovative technologies, the Global Regulatory Operations Reporting Service Manager enhances GSK’s ability to navigate the complex regulatory landscape, thereby supporting the successful registration, maintenance, and lifecycle management of GSK’s products worldwide.

Locations: Poland (Poznan), Belgium (Wavre)

Key Responsibilities:

• Leadership and Management:

Lead a team of reporting analysts and specialists, providing guidance, mentoring, and support to ensure high performance and professional growth

• Reporting Strategy:

Develop and implement a comprehensive reporting strategy that aligns with GSK’s regulatory operations goals and objectives, ensuring compliance with global regulatory requirements

• Data Integrity and Quality:

Oversee the accuracy, completeness, and integrity of regulatory data, ensuring that all reports are compliant with internal and external standards

• Stakeholder Collaboration:

Work closely with Regulatory Affairs, IT, Quality, and other cross-functional teams to understand reporting needs, gather requirements, and deliver effective reporting solutions

• Regulatory Compliance:

Ensure all regulatory reporting activities comply with applicable regulations, guidelines, and standards, including FDA, EMA, and other global regulatory bodies

• Process Improvement:

Continuously identify opportunities for process enhancements and efficiencies in regulatory reporting, implementing best practices and innovative solutions

• Technology Utilization:

Leverage advanced analytics, data visualization tools, and other technologies to optimize reporting processes and deliver actionable insights

• Project Management:

Manage multiple reporting projects simultaneously, ensuring timely and accurate delivery of regulatory reports and submissions

• Training and Development:

Develop and deliver training programs for team members and stakeholders on regulatory reporting processes, tools, and best practices

• Risk Management:

Identify potential risks in the reporting process and develop mitigation strategies to ensure continuous compliance and operational excellence

Why you? 

Basic Qualifications:

• High School or Secondary School completion in IT / Science / Technical area of specialization
• Preferred: Bachelor degree in scientific or technical area of specialization
• 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)
• Lead and participated in Business Change Teams delivering IT solutions for the business
• Extensive experience of working within a regulated project delivery environment
• Ability to communicate and provide assistance and support on both sides of the Business-IT interface
• Proven ability to interact effectively with senior managers within the organization
• Experience managing change control and system lifecycle within a regulated environment, ideally in drug / vaccines development
• Experience in Business Analysis and Business Process Design
• Experience with DevOps model for application of continuous improvement of deployed Power BI dashboards
• Fluent and able communicator in English and local language
• Strong communication and influencing skills
• Ability to self-manage the work and prioritize effectively
• Service orientation, customer-focused
• Good team worker, but with confidence to lead when appropriate
• Good understanding of IT lifecycle, processes and quality management
• Extensive Experience with Power BI development and support
• Software and System Experience (one of more of the following):

• 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
• SharePoint

Why GSK?

At GSK we offer a wide range of additional benefits: 

• Career at one of the leading global healthcare companies
• Hybrid work ( 2/3 days per week from the office)
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Company Car
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible
• Sports cards
• Possibilities of development within the role and company’s structure
• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, 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 every day

Inclusion at GSK:

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

#LI-GSK

#LI-HYBRID

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.

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/ Agencies

GSK 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 https://openpaymentsdata.cms.gov/