RIM Data Support & End User Expert

Role: Senior Specialist – Data Support & End User ExpertRegulatory Information Management (RIM)Location: Remote Type: Contract Job Description:Regulatory Dossier Management SupportProvide functional and operational support for regulatory dossier management activities, including:Dossier Lifecycle Oversight: Maintain a comprehensive, cross-market view of current, submitted, and superseded regulatory documents and dossier records within RIM systems.Data & Process Automation: Support automated generation, maintenance, and calculation of dossier records associated with regional submissions, global content plans, and health authority interactions.Configuration & Maintenance: Support the maintenance of dossier templates, object lifecycles, workflows, and country-specific generation rules within RIM platforms.Cross-Functional Support: Collaborate with Regulatory Affairs, Regulatory Operations, CMC, document management, and submission teams to ensure data traceability and resolve document or data discrepancies.Audit & Compliance Readiness: Ensure accurate tracking of translations, source documents, metadata, and status history across applicable markets, supporting inspection and audit readiness. Key ResponsibilitiesGuide the entry, updating, maintenance, correction, and archival of regulatory master data based on requests received from global RIM system users.Support the development, implementation, and maintenance of MDM standards and procedures for regulatory systems.Ensure sustained data quality through established validation, review, and quality-control processes.Act as a key liaison between data management teams and relevant stakeholders for process-related matters.Identify, document, and escalate operational issues, risks, and concerns as appropriate.Communicate stakeholder feedback and process updates to team members.Provide operational oversight to the data management team, ensuring:Team members are appropriately trained and understand their responsibilities.Service-level commitments and operational targets are achieved.Deliverables are completed accurately, consistently, and within agreed timelines.Identify opportunities for process optimization, standardization, and automation.Participate in governance and operational review meetings with relevant stakeholders.Support the development and implementation of reporting metrics, dashboards, and performance indicators.Analyze operational data to identify trends, risks, quality issues, and opportunities for continuous improvement.Promote adherence to applicable processes, procedures, quality standards, and data governance requirements. Required Skills & ExperienceExperience developing and maintaining master data management standards for regulatory or enterprise systems.Strong understanding of regulatory data management processes and workflows.Experience working with RIM, Regulatory Affairs, or related life-sciences systems and applications.Ability to process transactions accurately in accordance with established procedures, policies, and quality standards.Experience supporting project and operational activities in a global environment.Strong understanding of data quality, data governance, and data stewardship principles.Demonstrated ability to analyze information and translate findings into actionable data management improvements.Strong problem-solving, analytical, and decision-making skills.Excellent attention to detail and commitment to data accuracy.Strong stakeholder management and customer service skills.Experience managing processes and ensuring adherence to established standards and procedures.Experience with Six Sigma, Lean, or other process improvement methodologies.Experience developing and implementing standards, procedures, and operational guidelines.Strong reporting and analytical capabilities.Proficiency with Microsoft Excel and experience with regulatory reporting and data management tools.Ability to work effectively across geographically distributed and cross-functional teams.Strong organizational skills with the ability to manage multiple priorities and meet deadlines.Ability to handle confidential and sensitive business information appropriately. Key QualificationsExperience within a pharmaceutical, biotechnology, medical device, or other life-sciences organization operating in a global environment.Bachelor’s degree or equivalent qualification required.Experience leading or supporting data governance, master data management, process improvement, transformation, or operational excellence initiatives.Familiarity with reporting, analytics, dashboarding, and data visualization tools.Experience in regulatory data management or a closely related domain.Experience supporting global regulatory operations and working with geographically distributed teams.Willingness and ability to work US time-zone / US-shift hours is mandatory. Core CompetenciesRegulatory Information ManagementMaster Data ManagementData Governance & Data QualityRegulatory Data & Document ManagementDossier Lifecycle ManagementProcess Improvement & StandardizationReporting & AnalyticsStakeholder ManagementTeam Leadership & Operational OversightSix Sigma / Continuous ImprovementAudit & Compliance ReadinessRIM Systems & Regulatory Operations