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_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 |
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Numbers & Facts
| Location | Aurora, IL |
| Industry | Computer/IT Services |
| Company Size | 500 to 999 employees |
| Year Founded | 1990 |
| Website | http://q1tech.com/ |
About Company
Q1 consists of experienced and recognized experts providing the capability to respond to market demand in order to provide professional services for our clients including Enterprise software implementations, application integration and technical / functional support.
Q1 has steadily grown into a Quality IT services and solutions organization with the average experience of our team being over 10 years. We have continuously met or exceeded client expectations by delivering professional services and project implementations on time and under budget to help clients truly recognize return on investment.
Skills
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