Job Title:
Regulatory Systems Business Support Manager
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Summary:
A key role is available for a Regulatory Systems Business Support Manager to oversee the migration of an ongoing Veeva to Veeva regulatory information management system.
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Responsibilities:
* Executing planned activities within the migration plan to ensure project on-track status.
* Providing oversight and direction towards mapping requirements between two Veeva RIM systems.
* Ensuring successful deployment of migration strategies.
* Maintaining compliance with relevant regulations and internal policies throughout the migration process.
* Offering insight and technical knowledge for enrichment of regulatory data if necessary.
* Assisting the Systems and digital lead as needed throughout the project.
* Supporting migration verification strategies, risk assessment, and cut-over strategies.
* Collaborating with stakeholders to gather enriched data requirements and resolve any issues or discrepancies that arise.
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Qualifications & Experience:
* Bachelor's degree in a relevant discipline.
* Minimum 4 years of experience in the pharmaceutical/biotech industry, within Global Regulatory Affairs, Clinical, or Regulatory Operations, supporting systems.
* Experience within a Veeva Regulatory Information Management system is required.
* Preferably a white belt or system administrator training.
* Significant knowledge of Regulatory Affairs business processes, preferably experience with a regulatory information management migration project.
* Demonstrated experience managing, developing, and administering electronic document management systems, regulatory publishing systems, and regulatory tracking databases.
* Experience in maintaining GxP, Annex 11, and 21 CFR Part 11 computerized systems.
* Skills: Global Regulatory Affairs, Clinical, GxP, Veeva