Compliance Specialist Role
Há 9 horas
Job Title: Regulatory Compliance SpecialistThe primary objective of this role is to provide strategic support to the Global Development Information Management team by identifying and recommending improvements to business processes, regulatory data, and data definitions for the RIM platform.
This includes collaborating closely with cross-functional stakeholders such as IT, Clinical, Nonclinical, Quality, Global Regulatory Operations (GRO), and Global Regulatory Affairs (GRA).
Key Responsibilities:Process Improvement: Identify opportunities within the RIM platform to enhance compliance, efficiency, and reporting.Regulatory Support: Provide support to RIM Reporting and Analytics needs across Global Regulatory Affairs as needed.System Implementation: Contribute to the implementation of E2E RIM, including new system implementation, change requests, upgrades, integrations, data quality, metrics & reporting.Documentation: Ensure user requirements are adequately documented and serve as the basis for system continuous improvement, process engineering/mapping, and/or new system selection.Training and Change Management: Conduct training and support change management activities in RIM implementation and upgrades.Alignment and Integration: Track alignment of business processes and models across all business functions supporting global Regulatory product registrations.Emerging Standards: Monitor emerging structured data standards or health agency requirements, assess business impact, and define a roadmap for addressing them.Required Skills and Experience:6+ years of experience in working in a biotechnology or pharmaceutical Regulatory Affairs Operations environment.Experience in systems management or implementation in the life sciences industry or regulated industry.Must have experience in Veeva Vault RIM.Other system experience preferred and may include Calyx, Lorenz, Integras, SPORIFY, and other Veeva Vaults (PromoMat, eTMF, Quality).
Microsoft Office and Adobe systems.
• Knowledge of regulations, processes, and industry standards and best practices that govern regulated systems, records retention, and GxP.Compensation: $15/hour - $25/hr USDBenefits:- Competitive compensation package- Opportunities for professional growth and developmentWhy Join Us:- Collaborate with a talented team of professionals- Contribute to the success of a leading organization
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