Job Description
• Support efforts to align business processes to a RIM enterprise data strategy.
• Contribute to implementation of E2E RIM which includes new system implementation, change requests, upgrades, integrations, data quality, metrics & reporting, etc.
• Ensure user’s requirements are adequately documented and serve as the basis for system continuous improvement, process engineering/mapping, and/or new system selection.
• 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 and/or support 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.
• Lead and support Regulatory Operations Intelligence processes related to industry technology platforms and processes.
• Business process continuous improvement ensuring stakeholder, process and system alignment in compliance with evolving electronic data standards and submission of structured data. This may include reengineering or replacement of existing systems.
• Assist with external partnerships
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & 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
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.