Vertex Pharmaceuticals

The Science of Possibility

Regulatory Publishing Manager – Contract

ComplianceComplianceContractRemoteTeam 1,001-5,000Since 1989H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

14 days ago

Salary

Not specified

Bachelor Degree5 yrs expEnglishVault

Job Description

• Format complex regulatory documents in Microsoft Word to meet submission-ready standards. • Apply structured formatting, hyperlinks, bookmarks, cross-references, and linking best practices. • Convert Word source files into compliant, high-quality PDFs. • Work within Veeva Vault Publishing to manage document workflows and dynamic linking functionality. • Support report-level publishing (e.g., clinical reports, protocols, periodic reports). • Ensure alignment with global regulatory publishing standards and eCTD requirements. • Partner with document authors and SMEs to build quality into Word source documents early. • Provide guidance on submission-ready formatting standards. • Support refinement of evolving submission checklists and templates. • Manage multiple concurrent document priorities independently.

Job Requirements

  • 5–7 years of global regulatory publishing experience
  • Strong knowledge of eCTD structure and electronic submission requirements
  • Experience with Veeva Vault Publishing (direct experience strongly preferred)
  • Advanced Microsoft Word formatting expertise
  • Experience generating submission-ready PDFs
  • Ability to work independently in a developing, non–cookie-cutter environment
  • Strong attention to detail and quality mindset
  • Effective cross-functional communication skills

Benefits

  • Pay dependant upon experience
  • Overtime pay eligibility

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