Job Overview:
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* The role will be primarily responsible in the Global Development Information Management team, working closely with cross-functional stakeholders to identify and recommend improvements to business processes and regulatory data.
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Main Responsibilities:
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* To enhance compliance, efficiency, and reporting within the RIM platform, while collaborating with Global Regulatory Operations (GRO), Global Regulatory Affairs (GRA) and other teams.
* Support RIM Reporting and Analytics needs across Global Regulatory Affairs as required.
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Key Deliverables:
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* Align business processes with a RIM enterprise data strategy.
* Implement E2E RIM, including system implementation, change requests, upgrades, integrations, data quality, metrics & reporting.
* Ensure user requirements are adequately documented and serve as the basis for system continuous improvement and process engineering.
* Conduct training and support change management activities in RIM implementation and upgrades.
* Track alignment of business processes and models across all business functions supporting global Regulatory product registrations.
* Lead initiatives to integrate Regulatory information and records globally and for acquired assets and products.
* Monitor emerging structured data standards or health agency requirements, assess business impact and define roadmap for addressing them.
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Requirements:
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* 6+ years of experience in Regulatory Affairs Operations environment.
* Experience in systems management or implementation in 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.
* Microsoft Office and Adobe systems.
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Desirable Skills:
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* Knowledge of regulations, processes and industry standards and best practices that govern regulated systems, records retention and GxP.