Insight Global
Location: Basking Ridge,NJ, USA
Date: 2024-11-22T08:36:28Z
Job Description:
Act as a consultant and advisor providing guidance to improve business processes, products, services, and software through data analysis. Engage with business leaders and leverage the appropriate Regulatory teams to determine requirements and deliver data-driven recommendations to improve efficiency and add value. Facilitate meetings and workshops with stakeholders to gather feedback and present proposed solutions. Act as a liaison between the business units and the technical teams to ensure clear understanding of database requirements. Design and implement processes and supporting system solutions within Regulatory Information Management specially into Registration management. Create detailed business analysis, outlining problems, identifying gaps in existing functionality, opportunities, and solution recommendations. Ensure the maintenance of existing Regulatory tracking system and get involved in specification of minor change request and/or major upgrades as well as the overall user experience is considered in the design. Ability to review a comprehensive requirement specification that will determine the estimate of cost, time, and resources to deploy solutions. Ensure consistency and traceability between user requirements, functional specifications, and testing & validation. Support validation and testing (OQ, PQ, VAT...) Ensure the overall user experience is at the centre of the design for existing and new solutions. Ensure data integrity and accuracy by defining and implementing validation rules, error-handling procedures, and data quality standards. Support the design and develop reports, dashboards, and queries for analysis of registration data. Documentation & Training: Helping with preparation of user guides, system documentation, job aids and training materials for database u . Monitoring database usage, identify potential issues, and work with the technical team to resolve them. Provide ongoing support to end-u and act as the point of contact for any system-related issues.20-25/hrWe 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 ...@insightglobal.com . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: . Required Skills & ExperienceExperience in Regulatory Affairs domain (good understanding of key business processes), innovative medicines and global presenceo Experience in RIM (Regulatory Information Mgmt) business area, experience in Calyx and Veeva Registration implementation and system operations/maintenanceo Strong interpersonal, communication, collaboration and analytical skills with ability to communicate effectively with a diverse internal and external audience and to interpret and communicate complex information. 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.
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