Syneos Health

Regulatory Publishing Specialist – Veeva Experience Required

Syneos Health

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇦🇷 Argentina

Visit company website
AI Apply
Apply

Job Level

Mid-LevelSenior

Tech Stack

Vault

About the role

  • Perform Assembler tasks within the document publishing system
  • Troubleshoot issues with eCTD builds and provide guidance to the entry level publishers
  • Prepare and assemble applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to global regulatory authorities
  • Lead team to produce compliant, submission-ready PDFs from the Word source files

Requirements

  • Experience with collaborative authoring and Dynamic Linking in Veeva Vault Publishing would be highly preferable
  • Experience working closely with Document authors/functional SMEs
  • Performs Publishing tasks within the electronic publishing system, including, but not limited to, adding special sheets, applying rules, preparing for publishing, and publishing
  • May log and track regulatory documents, publications, and other relevant materials
Benefits
  • Career development and progression
  • Supportive and engaged line management
  • Technical and therapeutic area training
  • Peer recognition
  • Total rewards program

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Assembler taskseCTD buildsdocument publishingcollaborative authoringDynamic Linkingpublishing tasksregulatory submissionsPDF productionWord source filesspecial sheets
Soft skills
troubleshootingguidanceteam leadershipcollaborationcommunication