Job Description
Job DescriptionJob Description:Please strictly adhere to the following resume naming convention:
ALL CAPS, NO SPACES B/T UNDERSCORES
PTN_US_GBAMSREQID_CandidateBeelineID
i.e. PTN_US_9999999_SKIPJOHNSON0413
MSP Owner: William Bristol
Location: See Below
Duration: 6 months
Role Descriptions: 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.
Essential Skills: 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.
Desirable Skills:
Keyword:
Skills: Veeva Vault Platform~Veeva CRM
Experience Required: 10 & Above