Job Title

About FreyrFreyr is a leading Regulatory Solutions and Services company supporting global Life Sciences organizations across Regulatory Affairs, Pharmacovigilance, Quality, and Compliance.Job Title: RA Data Governance SpecialistLocation: Canada RemoteEmployment Type: Full-Time / ContractRole OverviewSupport Regulatory Affairs (RA) data governance, data quality, and data modelling activities, ensuring alignment with enterprise standards, regulatory requirements, and internal processes.Key/Primary Responsibilities:Governance and Stewardship:Maintain RA data governance frameworks, including roles for data owners and stewardsOversee tickets and workflows for reference and master data changes (organization, substance, medicinal product). Service Now (SNOW)Support harmonization of Regulatory reference and Master data models with enterprise standards (e.g., medicinal product, device, packaging hierarchies).Support IDMP-based modelling and alignment of data between RIM and Master Data management systemParticipate in medicinal product governance meetings and expert community sessions.Support enterprise-level modelling principles (conceptual, logical, physical) and metadata management against internal and external benchmarksPerform routine data quality checks and generate metrics reports.Coordinate with Data Stewards and functional Data Owners to resolve data quality issues.Track and report on KPIs related to accuracy, consistency, and completeness.Act as operational liaison for RA Data Governance activities with internal teams.Support communication and training sessions on data governance processes and systems.Provide operational input and resources for projects impacting RA data governance.Assist in configuration and testing of data governance toolsManage Jira boards for RA data initiatives, including backlog prioritization, epics, and user stories. Ensure traceability of requirements and validation results in Jira for compliance. Monitor backlog and escalate issues as necessary.Support running and reporting on KPIsAnalyze data quality trends, monitoring progress and report findings to leadershipPrepare compliance reports for regulatory requirements (e.g., IDMP, XEVMPD)Automate routine reporting tasks to improve efficiencyTranslate analytics into actionable insights for stakeholdersBenchmark internal metrics against industry standardsGather feedback from users to continuously improve reporting tools and outputsMaintain and update data governance documentation, data catalogue entries, and controlled vocabularies.Execute codification of rules in Data Quality tools and monitor adherence.Support centralized master and reference data management (MDM/RDM) processes.Secondary ResponsibilitiesData Modelling:Support harmonization of Regulatory reference and Master data models with enterprise standards (e.g., medicinal product, device, packaging hierarchies).Support IDMP-based modelling and alignment of data between RIM and Master Data management systemParticipate in medicinal product governance meetings and expert community sessions.Support enterprise-level modelling principles (conceptual, logical, physical) and metadata management against internal and external benchmarksData Quality Management:Perform routine data quality checks and generate metrics reports.Coordinate with Data Stewards and functional Data Owners to resolve data quality issues.Track and report on KPIs related to accuracy, consistency, and completeness.Interactions / Stakeholder CoordinationAct as operational liaison for RA Data Governance activities with internal teams.Support communication and training sessions on data governance processes and systems.Project & Project Management SupportProvide operational input and resources for projects impacting RA data governance.Assist in configuration and testing of data governance toolsManage Jira boards for RA data initiatives, including backlog prioritization, epics, and user stories. Ensure traceability of requirements and validation results in Jira for compliance. Monitor backlog and escalate issues as necessary.Reporting and AnalyticsSupport running and reporting on KPIsAnalyze data quality trends, monitoring progress and report findings to leadershipPrepare compliance reports for regulatory requirements (e.g., IDMP, XEVMPD)Automate routine reporting tasks to improve efficiencyTranslate analytics into actionable insights for stakeholdersBenchmark internal metrics against industry standardsGather feedback from users to continuously improve reporting tools and outputsQualifications & ExperienceEducation: Bachelors degree in life sciences, data science, or related field.Experience: 35 years in data governance, data quality, or regulatory data management.Technical SkillsExperience with data management in pharmaceutical regulatory affairs.Familiarity with regulatory requirements, structured data submissions, and compliance practices, including XEVMPD & IDMPFamiliarity with data management and data quality/governance tools like Reltio, Collibra and AtaccamaFamiliarity with Veeva RIM, Service Now, Jira and SAP appreciatedSoft SkillsStrong communication, business writing, and project management skills.Experience facilitating meetings with cross-functional teamsWhat We OfferCompetitive compensation, global exposure, and opportunity to work on cutting-edge regulatory data governance initiatives.Why Join FreyrBe part of a fast-growing organization driving innovation in Regulatory Affairs and Data Governance across global life sciences companies.