Senior / Regulatory Specialist, Regulatory Information Management

The information (data and documents) managed by Regulatory Information Management is critical to patient safety, regulatory compliance and effective business operations. The post holder is accountable for the quality and accuracy of their own work and for the support of the large number of other users across GSK. The role provides operational support to Regulatory Information Management Systems (RIMS) end-users.

In this role you will….

• Be responsible for accurate completion of more complex or non-routine data maintenance tasks to agreed schedule
• Supervise, support and monitor quality of the work of junior colleagues
• Advise, train and support users of the global Regulatory Information Management (RIM) systems and procedures
• Ensure own work and that of junior colleagues is compliant with data standards and defined procedures
• Ensure defined quality control procedures are followed and appropriate actions taken following any issues identified during routine quality monitoring activities.
• Trouble shoot problems when required and propose appropriate solutions
• Identify areas for improvements/efficiencies in existing processes and contributes to the Regulatory Information Management Systems (RIMS) Change Control Process
• Maintain knowledge of GSK standards and procedures associated with registration data management and contribute to the definition of new and revised procedures to improve quality and effectiveness
• Routine/ ad-hoc extraction and transformation of raw data from various Regulatory Information Management Systems (RIMS) for KPI generation in the context of data quality improvement and performance monitoring

Why you?

BASIC REQUIREMENTS:

• Min Bachelor’s degree from preferably: IT, chemistry, pharmacy or other related science or regulatory affairs, Project Management, Communication area
• Sound experience in data and/or record management, handling user requests; consistent and accurate completion of a significant number of data management tasks, including a broad range of regulatory procedures
• Competency in the use of regulatory information management tools
• Proven ability to work on multiple projects simultaneously and demonstrated organisational skills
• Excellent written and verbal communication skills in English and Polish, and ability to present information in a clear and concise manner
• Strong interpersonal skills, service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment
• Excel macro/pivot table skills and Veeva Valut would be a plus
• Knowledge of records retention procedures and relevant regulations and business practices regarding regulatory document management.
• Customer Focus, Enable and drive change, Service orientation, customer-focused
• Awareness of Regulatory Information Management Systems and their criticality to legislative requirements
• Please note we are open to hire either a specialist or a senior specialist, depending on your experience and background

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)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible counterparts
• Sports cards (Multisport)
• 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

#LI-GSK

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Inclusion at GSK: 

As an employer committed to Diversity and Inclusion, 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.

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.

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