USA_Developer
Varite Inc
Cambridge, MA, United States
1 day ago
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Role details
Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
7 years minimum
Compensation
$100,131.0 - $107,848.0
Working hours
Regular working hours
Job source
Tech stack
Data Migration
Documentum
Release Management
SAP (Applications)
Iq/oq/pq
Data Strategy
Veeva
VeevaVault
GXP
Legacy Systems
Job description
| Lead the implementation | configuration | and support of Veeva Vault RIM Suite | including Registrations | Submissions | Submissions Archive | and RegulatoryOne modules.Collaborate with Regulatory Affairs | Clinical | Quality | and IT teams to gather business requirements and translate them into scalable Veeva RIMS solutions.Manage the end-to-end lifecycle of global regulatory submissions | registrations | renewals | variations | and health authority correspondence within Veeva Vault RIM.Configure and maintain Veeva objects | document types | lifecycles | workflows | security roles | metadata | and reporting capabilities.Drive regulatory data migration activities from legacy systems to Veeva Vault RIM | ensuring data accuracy | completeness | and compliance.Support integration of Veeva RIM with enterprise platforms such as Veeva Quality | Safety | Clinical | SAP | ERP systems | Documentum | and other regulatory repositories.Develop and execute validation deliverables including URS | FS | RTM | IQ/OQ/PQ | and testing |
| documentation in compliance with GxP | FDA 21 CFR Part 11 | EMA | and global regulatory requirements.Analyze regulatory operations processes and recommend automation | standardization | and continuous improvement opportunities to enhance compliance and submission efficiency.Provide production support | issue resolution | release management | and user training while ensuring adherence to SLAs and regulatory governance standards.Act as a subject matter expert (SME) for Veeva RIMS | advising stakeholders on best practices | regulatory data management strategies | system enhancements | and future roadmap initiatives. |
Requirements
Skills:CategoryNameRequiredImportanceExperienceSkillCategoryTest1_MNVeeva CRMYes1>7 years SkillCategoryTest1_MNVeeva Vault PlatformYes1>7 years
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