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
• Minimum 2-3 years of 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 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

Why GSK?

We also offer a wide range of additional benefits:

• Career at one of the leading global healthcare companies
• 2/3 days per week form the office
• 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.
• 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 every day

Inclusion & Diversity at GSK:
Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career.
GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant.
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(pl.recruitment-)to further discuss this today.
We will request equal opportunities information from you and whilst disclosure is optional, we encourage you to be open, enabling us to monitor the inclusivity of our recruitment practices for the benefit of everyone. Your data will remain confidential, is never shared with our Hiring Managers and never affects the status of your application. *Local restrictions/legal requirements

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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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).

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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