Regulatory Operations Consultant
Cambridge, Massachusetts, United States
Job Description
Job description:
- Our client is seeking an experienced Regulatory Operations Consultant to support Veeva Vault RIM, with a primary focus on archiving legacy regulatory content and mitigating documentation into Veeva Vault. This role will play a key part in submission readiness, ensuring regulatory documentation is properly structured, archived, migrated, and maintained in accordance with current regulatory and system standards.
- The ideal candidate will have hands-on experience working in the current version of Veeva Vault RIM and a strong understanding of regulatory submission workflows, content planning, and document lifecycle management.
- Support day-to-day Veeva Vault RIM operations, with a focus on archiving and remediation of regulatory documentation.
- Execute and maintain submission content plans, ensuring accurate document structure, metadata, and lifecycle states.
- Perform archiving and mitigation of legacy regulatory content into Veeva Vault in alignment with internal standards and regulatory requirements.
- Support submission readiness activities, including document QC, completeness checks, and inspection preparedness.
- Conduct configuration testing within Veeva Vault RIM to validate workflows, metadata, and submission outputs.
- Support development and delivery of end-user training, including SOPs, job aids, and hands-on system guidance.
- Prepare, QC, and finalize regulatory documents using Adobe Acrobat (bookmarking, hyperlinking, formatting, and optimization).
- Utilize DocShifter to support document conversion and submission-ready outputs.
- Partner cross-functionally with Regulatory Affairs, Publishing, and IT stakeholders.
- Identify process gaps and recommend improvements related to regulatory content management and system use.
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Career Focus: Regulatory
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