Quick overview
Job description
Job Description Job Description Job 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 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
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