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

Job Purpose:

Elevate Your Career with GSK’s Regulatory Information Management & Data Office!

Are you ready to make a significant impact on patient safety and business efficiency? Join our dynamic team to drive innovation, ensure data integrity, and support global regulatory processes. Be a part of a fully harmonized global team that continuously seeks innovative opportunities to improve ways of working and drive automation. Apply now to contribute to the future of healthcare at GSK!

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, 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 Dat 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.

Why You?

Basic Qualifications:

• Bachelor’s degree in a scientific or technical area of study
• Must have experience 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 dataset

Preferred Qualifications:

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

• Advanced degree in a scientific or technical area of study
• 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.

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.
• This is a job description to aide in the job posting, but does not include all job evaluation details.

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 canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Read Full Description