City : 100 Milverton Drive

Category : Autre

Industry : Healthcare

Employer : GSK

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.

GSK est un employeur qui prône l'égalité des chances et s'engage en faveur de la diversité et de l'inclusion. Nous invitons toutes les personnes qualifiées à postuler à nos offres d'emploi. GSK s'engage à tenir compte des besoins des personnes handicapées. Si vous avez besoin d'un logement à n'importe quel stade de la procédure de candidature ou si vous souhaitez plus d'informations sur nos politiques de logement, veuillez nous contacter à l'adresse canada-recruitment@gsk.com. Merci de ne pas envoyer votre curriculum vitae à cette adresse électronique et de postuler via la procédure de candidature en ligne pour ce poste.

En tant qu’entreprise axée sur la santé et la science, GSK est résolue à suivre les recommandations énoncées par Santé Canada et à prendre toutes les mesures nécessaires pour aider à freiner la propagation de la COVID-19, ce qui comprend la vaccination contre la COVID‑19. Nous croyons fermement que c’est la meilleure façon d’aider à protéger ceux qui nous importent le plus : nos employés, les membres de nos familles et de nos collectivités, ainsi que les patients et les consommateurs que nous servons. À cette fin, nous avons pris une mesure de taille pour assurer la sécurité de nos employés pendant cette crise mondiale de santé publique.

Ainsi, seuls les employés entièrement vaccinés contre la COVID-19 peuvent se rendre à nos bureaux de Mississauga et de Laval (Montréal). De plus, tous les employés en contact direct avec les clients qui, dans le cadre de leur travail, fréquentent des établissements de soins de santé comme les hôpitaux, les pharmacies ainsi que les cabinets de médecins et de dentistes devront être entièrement vaccinés contre la COVID-19. Malgré ce qui précède, les employés peuvent demander une mesure d’adaptation pour des motifs liés aux droits de la personne, y compris des problèmes de santé ou des croyances religieuses. La santé et la sécurité de nos employés demeurent l’une de nos grandes priorités.

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