Regulatory Publishing Manager

This role supports document-level regulatory publishing activities within a global Veeva Vault Publishing environment, focusing on preparing submission-ready regulatory documents through advanced Microsoft Word formatting, dynamic linking within Veeva, and compliant PDF generation.

Responsibilities

• 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.

Qualifications

• Bachelor’s degree preferred but not required.
• Experience supporting global regulatory submissions required.
• Experience working in a system transition or evolving publishing environment preferred.

Pay

$65/hr - $75/hr

Schedule

• 12-month contract, with the chance to extend.
• Monday - Friday, remote, EST hours.