Regulatory Publishing Manager
Company: Careers Integrated Resources Inc
Location: Princeton
Posted on: June 28, 2025
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Job Description:
Job Title: Regulatory Publishing Manager Location: Princeton, NJ
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 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 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, Brentwood , Regulatory Publishing Manager, Science, Research & Development , Princeton, New York
