Specialist, Regulatory Information Management (RIM) & Data Office

Job Purpose

Join Our Team! Ensure patient safety, regulatory compliance, and operational excellence by managing critical data and documents. Uphold the highest standards of quality and accuracy, and provide essential support to GSK’s global regulatory functions. Apply now to make a significant impact. 

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
• Accurate completion of routine data maintenance tasks to agreed schedule
• Ensure own work 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
• 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
• Maintain knowledge of GSK standards and procedures associated with RIMS and contribute to the definition of new and revised procedures to improve quality and effectiveness
• Indexing, abstracting and quality assurance of Health Authority (HA) submissions and associated correspondence into established regulatory document management system(s). 
• Support customer requests, as needed, by conducting specific searches for proprietary regulatory information using on-line databases.
• 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
• Working on projects as required in response to internal and external customer requests.
• Identify areas for improvements/efficiencies in existing processes and contributes to the Regulatory Information Management Systems (RIMS) Change Control Process

Why you?

Basic Qualifications:

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

• Bachelor’s degree in a scientific or technical field of study
• 3-5 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
• Demonstrated ability to proactively manage workload, timelines and identify priorities. • Interacts with customers to ensure compliance with regulatory records and data management requirement
• Direct or indirect experience of regulatory processes associated with gaining and maintaining product registrations (for both Investigational and Marketed Products) and Regulatory Information Management Systems
• Has worked successfully with a complex computer system

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master’s degree
• 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
• 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 is advantageous
• Ability to present and actively communicate Regulatory Archives requirements and policies and champion change.
• Knowledge of records retention procedures and relevant regulations and business practices regarding regulatory document management.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

#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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