Regulatory Publishing Manager – Contract

This is a fully remote position, open to applicants in United States.

📋 Description

• Format intricate regulatory documents in Microsoft Word to achieve submission-ready standards.

• Implement structured formatting, hyperlinks, bookmarks, cross-references, and best practices for linking.

• Transform Word source files into compliant, high-quality PDFs.

• Utilize Veeva Vault Publishing to oversee document workflows and dynamic linking capabilities.

• Assist in report-level publishing (e.g., clinical reports, protocols, periodic reports).

• Ensure compliance with global regulatory publishing standards and eCTD requirements.

• Collaborate with document authors and SMEs to incorporate quality into Word source documents at an early stage.

• Offer guidance on standards for submission-ready formatting.

• Aid in the refinement of evolving submission checklists and templates.

• Independently manage multiple concurrent document priorities.

⛳️ Requirements

• 5–7 years of experience in global regulatory publishing.

• In-depth knowledge of eCTD structure and electronic submission requirements.

• Experience with Veeva Vault Publishing (direct experience is highly preferred).

• Advanced expertise in Microsoft Word formatting.

• Experience in generating submission-ready PDFs.

• Capability to work independently in a developing, non-standardized environment.

• Strong attention to detail and a quality-focused mindset.

• Effective communication skills across cross-functional teams.

🏝️ Benefits

• Compensation, medical benefits, fringe benefits, and other employment terms and conditions will be provided by the third-party agency partner upon offer.

• Overtime pay in accordance with federal and state regulations.