Regulatory Publishing Manager – Contract
Vertex Pharmaceuticals
contract
Posted on:
Location Type: Remote
Location: United States
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Tech Stack
About the role
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Microsoft Word formattingPDF generationeCTD structureregulatory document formattingdocument workflow managementdynamic linkingsubmission-ready standardschecklist refinementtemplate development
Soft Skills
attention to detailquality mindsetindependent workcross-functional communication