Senior Specialist

Key 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, adhoc 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.

​Basic qualifications-

• A minimum of 6-8 years of experience in data and or records management, handling user requests.

• Consistently accurate completion of a significant number of data management tasks including a broad range of procedures.

Related experience -

• 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

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  • 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 organisational 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, prioritisation 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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment- to discuss your needs.

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