Regulatory Publishing Specialist – Veeva Experience Required
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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About the role
- Performs Assembler tasks within the document publishing system, including, but not limited to, creating publications, modifying outline, assigning and transforming documents, and adding cross references.
- Performs Publishing tasks within the electronic publishing system, including, but not limited to, adding special sheets, applying rules, preparing for publishing, and publishing.
- Performs QC tasks within the electronic publishing system and QC of the published output.
- May QC materials prepared by team or client.
- May create, key, and assemble client deliverable documents and submissions using standard word processing or publishing systems and utilities (Extedo’s eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat and others).
- Takes lead role in preparing full application submission builds.
- Troubleshoots issues with eCTD builds and provides guidance to the entry level publishers.
- Provides assistance and guidance to entry-level publishers.
- May review documents for legibility, completeness, and accuracy.
- May log and track regulatory documents, publications, and other relevant materials.
- May organize and compile regulatory documentation, perform pagination, clean-up, and duplication tasks.
- May receive and deliver client information/documents, with significant supervision.
- May provide alternatives for completing assigned tasks.
- Prepares and assembles applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to global regulatory authorities.
- Leads team to produce compliant, submission-ready PDFs from the Word source files.
- Completes report level publishing (CSR, DSUR, PSUR, Protocols).
- Completes CSR submission assembly
Requirements
- Experience with collaborative authoring and Dynamic Linking in Veeva Vault Publishing would be highly preferable
- Experience working closely with Document authors/functional SMEs to ensure global quality is built into the Word source docs to reduce time-to-file and promote global document reusability
- SME on global submission-ready standards, Word format, PDF formatting
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
document publishingQC tasksapplication submission buildsreport level publishingcollaborative authoringDynamic Linkingglobal submission-ready standardsWord formatPDF formatting
Soft skills
guidanceleadershiporganizationcommunication