Solution Architect – Regulatory Information Management (RIM)

Job role: Solution Architect – Regulatory Information Management (RIM)Location: Richmond, VA (Remote)Work Arrangement: RemoteWorking Hours: Monday–FridayPay Rate: $40-$50/hr on W2Domain: ITEmployment Type: ContractDuration: 3 Month CTHApplication Deadline: Open until FilledJob Description:This company is implementing Ennov Regulatory Information Management (RIM) as the strategic platform to support regulatory submissions, regulatory correspondence, submission lifecycle management, reporting, workflow automation, integrations, and archival capabilities. Ennov has been selected as the preferred RIM solution following a vendor evaluation process.The Solution Architect will be responsible for the end-to-end architecture, design governance, integration strategy, data migration approach, and technical leadership for the implementation of the Ennov RIM platform. The role will work closely with Regulatory Affairs, Quality, Enterprise Architecture, Data, Integration, Security, and Vendor teams to ensure successful deployment and alignment with enterprise standards.The RIM platform is expected to enable regulatory registrations, submissions, publishing, archival, workflow automation, and integration of regulatory data across the enterpriseKey Responsibilities:Solution Architecture & DesignConfigure master data to support regulatory submission identification, templates and analysisConfigure submission templates (to accelerate construction of submissions)Configure submission workflow templates (to assure routing for review and approval in the most efficient manner)Configure supporting templates and workflows, such as Regulatory CorrespondenceConfigure submission archivingDeliver reporting and dashboards for both master data and the submissions process (dashboards)Deliver integration to support Master Data updatesDeliver integration to support submissions development (e.g. data files, studies reports)Perform data migration of in-scope completed submissions, attaching migrated submissions to appropriate master data and dispositionExperience:10+ years of enterprise application architecture experience.5+ years as Solution Architect for enterprise software implementations.Prior experience implementing:Regulatory Information Management (RIM)Regulatory Affairs applicationsQuality Management SystemsClinical or Life Sciences platformsRegulatory Domain ExperienceStrong understanding of:Regulatory Affairs processesSubmission managementProduct registrationsRegulatory correspondenceSubmission publishingRegulatory archivesBenifitsMedical | Dental | Vision | 401(k)EEOC Compliance:We are an equal opportunity employer, and all qualified applicants will receive consideration for employment.Disclaimer:AI Usage Policy: Pacer Group uses AI to assist in screening applications. Final hiring decisions are made by human recruiters based on qualifications and experience.