
201 - 500 employees
Founded 2020
💊 Pharmaceuticals
Healthcare • Pharmaceuticals • IT Services
Slipstream IT is a strategic partner specializing in redefining IT solutions for the life sciences sector. They offer a comprehensive range of services including IT strategy and consulting, cloud-based solutions, and IT support specifically tailored to healthcare and pharmaceutical companies. With a focus on streamlining IT management and enhancing compliance and quality, Slipstream provides expertise as a certified Veeva solutions provider, serving over 200 clients in the life sciences industry.
🔥 12 hours ago
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201 - 500 employees
Founded 2020
💊 Pharmaceuticals
Healthcare • Pharmaceuticals • IT Services
Slipstream IT is a strategic partner specializing in redefining IT solutions for the life sciences sector. They offer a comprehensive range of services including IT strategy and consulting, cloud-based solutions, and IT support specifically tailored to healthcare and pharmaceutical companies. With a focus on streamlining IT management and enhancing compliance and quality, Slipstream provides expertise as a certified Veeva solutions provider, serving over 200 clients in the life sciences industry.
• Serving as the primary liaison between Regulatory Affairs/Operations business stakeholders and IT/platform teams, translating regulatory business needs into system requirements and configuration specifications. • Supporting implementation, migration, and ongoing managed services engagements across Regulatory Information Management (RIM) platforms, independent of underlying vendor (e.g., Veeva Vault RIM, Generis CARA, Ennov RIM, ArisGlobal LOOP, MasterControl RIM, EXTEDO RIMS). • Facilitating requirements gathering, process mapping, and vendor-neutral system evaluation to support client regulatory technology strategy and roadmap decisions. • Acting as the functional point of contact for client-reported issues, enhancement requests, and release management activities, coordinating with technical configuration and IT teams to deliver resolution. • Own intake, triage, and prioritization of managed services requests and tickets across client RIM environments, regardless of platform. • Support release management processes, including regression testing coordination, UAT script development and execution, and release notes review, for whichever RIM or adjacent platform a client operates. • Identify and document process improvement and automation opportunities across the regulatory technology landscape. • Maintain SOPs, business process documentation, and system configuration specifications for client-facing and internal use.
• 3-5+ years of business analyst experience within regulatory affairs/regulatory operations technology environments, spanning at least one RIM platform (Veeva Vault RIM, Generis CARA, Ennov RIM, ArisGlobal LOOP, MasterControl RIM, EXTEDO RIMS, or equivalent). • Bachelor's degree in Life Sciences, Information Systems, Business Administration, or a related field. • Demonstrated business analysis skills: requirements elicitation, process mapping, functional specification writing, and backlog/user story authoring. • Working knowledge of at least one enterprise RIM platform (Veeva Vault RIM, Generis CARA, Ennov RIM, ArisGlobal LOOP, MasterControl RIM, or EXTEDO RIMS), with the ability to learn others quickly. • Familiarity with the broader regulatory technology and enterprise systems landscape, including Salesforce (CRM/Health Cloud), ServiceNow, SAP, or comparable platforms, and how regulatory data intersects with them. • Understanding of eCTD structure (ICH M8), regional submission requirements, and RIM/registration data models, independent of vendor. • Understanding of GxP computer system validation (CSV) principles as applied to configuration changes in a regulated environment. • Strong facilitation and stakeholder management skills; comfortable running workshops with both business and technical audiences. • Ability to translate ambiguous business needs into clear, testable requirements and configuration specifications. • Excellent written and verbal communication skills; capable of presenting to both regulatory business stakeholders and IT/engineering teams. • Ability to manage multiple client environments, platforms, and competing priorities in a consulting/services setting.
• Exceptional client outcomes
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