Senior Specialist, Regulatory Information Management (RIM) & Data Office

Job Purpose

Are you passionate about regulatory excellence and innovation? Join our global team at GSK as a Senior Specialist in Regulatory Information Management & Data Office and make a real impact on patient safety and business efficiency. Enjoy competitive benefits, opportunities for professional growth, and the chance to drive automation and continuous improvement. Apply now and be a part of our journey!

Details (Your Responsibilities):

Sharing Subject Matter Expertise in Regulatory Information Management Systems and Processes in-use within Global Regulatory Affairs, requiring a deep understanding of the Regulatory Vault data model and legacy RIM systems:

• Creation and maintenance of Regulatory Information within the company’s Regulatory Information Management (RIM)
• system with information provided ‘on demand’ by end users for all GRA Submission activities – typically supporting urgent ‘timebound’ requests.
• Accurate completion of more complex or non-routine data maintenance tasks to an agreed schedule
• Provision of primary support to end users of RIM systems and processes to enable efficient ways of working including provide basic guidance, ad hoc training, attendance at group meetings, provision of appropriate Reports etc.
• Monitoring data quality routinely to identify and mitigate issues. Additionally, conducting root cause analysis and trend analysis to identify appropriate corrective/preventative actions
• Ensure own work and that of junior colleagues is compliant with data standards and defined procedures
• Streamlining regulatory information communication to Manufacturing and/or QA Release stakeholders to facilitate Supply Chain and QA Release operations
• Routine/ ad-hoc extraction and transformation of raw data from various Regulatory Information Management (RIM) systems for KPI generation in the context of data quality improvement and performance monitoring
• Provision of support for system validation activities such as User Acceptance Testing, with a foundational understanding of the requirements of the Change Control procedures for enabling full impact assessment of any system/process change.
• Responsible for establishing & maintaining appropriate procedural documentation where needed: SOP, WI, How to Guide, User Manuals and Handbooks
• Ensuring continuous improvement (process & system) culture within the team for the benefit of GRA. Ensure understanding of upcoming system changes, propose changes and support the implementation of those changes within RIM.
• Where applicable, perform the role of RIM Subject Matter Expert, driving a partnership with GRA Process Leads, developing deep understanding of GRA E2E business process, sharing technical expertise to support the business and continuous improvement.
• Mentoring and support of new starters or junior colleagues
• Ensuring appropriate procedures are followed in the maintenance of System Reference Data

Why You?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree; in Regulatory Information Management (RIM) AND/OR previous work experience in a customer facing role utilizing databases within a regulated environment
• Fluent in English (written and oral)
• Good understanding of the role and responsibility of Registration Information Management
• Awareness of standard submission formats, with ability to navigate submission content
• Awareness of relevant health authority regulations and guidance, technology trends, as well as industry standards concerning record keeping practices, document/information management and HA submission requirements.
• Knowledge of records retention procedures and relevant regulations and business practices regarding regulatory document management
• Analytical capability; ability to work with large and varied datasets
• Good interpersonal skills, service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary, global, and matrix environment.
• Familiarity with GSK organization and processes associated with gaining and maintaining marketed and investigational product authorizations
• Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Demonstrated knowledge of GSK Marketed Products and development products. Awareness of drug development process
• Organization, prioritization and coordination skills
• Demonstrated proficiency in use of standard IT tools
• Familiarity with GSK IT systems in general and RIM tools, plus awareness of system validation methodology

Preferred Qualifications:

• Advanced degree in Regulatory Information Management (RIM) AND/OR previous work experience in a customer facing role utilizing databases within a regulated environment

#LI-GSK

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 employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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