Regulatory Publishing Manager

Company: Careers Integrated Resources Inc
Location: San Diego
Posted on: June 28, 2025

Job Description:

Job Title: Regulatory Publishing Manager Location: San Diego, CA Duration: 3 Months Pay rate: $53.23/hr. on W2 Duties: The Manager/Sr. Manager, Regulatory Publishing is responsible for publishing, QC, and transmittal of eCTD submissions, as well as document formatting and report-level publishing. This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports in alignment with health authority guidelines and industry best practices. Primary Responsibilities: • Using Client's eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions and reports in alignment with health authority guidelines and industry best practices. • For authored documents, ensure formatting is applied consistently according to Client's Style Guide. • As needed, prepare PDF documents for inclusion in regulatory submissions by editing bookmarks, hyperlinks, and other elements to ensure submission-readiness. • QC published eCTD submissions and reports, working collaboratively with teammates to resolve findings and issues. • Support authors and contributors to documents/reports to be included in regulatory submissions by advising on use of Veeva Vault RIM. • For clinical study reports, deliver Regulatory Operations kickoff slides (covering use of Veeva Vault RIM and tracking of appendices). • For clinical study reports, work with SMEs/authors to track status of appendices and manage overall timelines for completion. • As needed, work with system business owners, IT, and QA to support system. implementations and updates including execution of validation scripts.

Keywords: Careers Integrated Resources Inc, San Bernardino , Regulatory Publishing Manager, Science, Research & Development , San Diego, California