JVT Advisors Sr. System Engineer, Regulatory & Content Management Systems in Cambridge, Massachusetts
Contract Length: 6+ months
Job Summary: As the lead technical resource for the content management systems team you'll ensure our platform's reliable, compliant and scalable operations to support the company’s extensive portfolio. You'll support colleagues in regulatory operations, clinical, medical affairs and Pharmacovigilance, enabling them to get the most value out of our digital platforms.
· Organize, manage and perform platform support activities
· Define and manage application enhancement process and release management for R&D Clinical applications such as SAS, Data management apps e.g., Clinical Data Repository
· Provide daily operations support to business groups including user accounts creation, system troubleshooting etc.
· Perform Change management activities in GxP environment including authoring and getting changes reviewed and approved in ServiceNow
· Maintain all system related digital SOPs, WIs, system administration guides to keep content Gxp compliant
· 7+ years' experience as a system manager/administrator
· Deep and proven experience in system engineering and maintenance across a wide span of GxP applications with a focus on data platforms (SAS, EDC, SDMS)
· Experience with lab systems such as LIMS
· Familiarity with AWS environment for applications and platforms hosting
· Working knowledge of CSV concepts for SaaS GxP applications and robust understanding and practice of change management
· Tangible track record in using Agile approaches in a regulated environment