Remote Regulatory Document Specialist - Word Processing Pro

Spectraforce; United States; Remote; USD 75,000 - 105,000; Full time

Job summary

Spectraforce seeks a Regulatory Document Specialist/Medical Writing Word Processing Coordinator II for 100% remote work in the United States. The role centers on hands-on document formatting, PDF generation, and submission-readiness, not content creation or editing.

You will partner with Medical Writers and Regulatory teams to ensure all documents meet eSubmissions standards. Key duties include advanced Word formatting, dynamic TOC development, PDF rendering, metadata management, and CSR

Qualifications

• Hands-on formatting focused role, not content writing.
• Experience with eCTD and regulatory submissions.
• Proficiency with Word templates and styles.
• Experience with RIMS/eDMS like Veeva Vault.
• Knowledge of regulatory submission structures and CSRs.
• 3+ years in regulatory operations or document publishing.

Responsibilities

• Advanced document formatting in Word using master styles.
• Build dynamic TOCs, cross-references, bookmarks, hyperlinks, headers/footers.
• Render and QC PDFs for eSubmissions compliance.
• Manage documents in RIMS/eDMS and repositories.
• Coordinate CSR appendices and lifecycle support.
• Populate metadata and maintain file-naming conventions.
• Troubleshoot formatting issues and rendering discrepancies.
• Coordinate timelines with authors and medical writers.

Skills

Word Formatting

PDF generation

TOC & References

RIMS/eDMS

ICH/eCTD knowledge

Regulatory submissions

Education

Bachelor's degree in Life Sciences or related

Tools

Veeva Vault

Documentum

Cosmos

Job description

Spectraforce seeks a Regulatory Document Specialist/Medical Writing Word Processing Coordinator II for 100% remote work in the United States. The role centers on hands-on document formatting, PDF generation, and submission-readiness, not content creation or editing.

You will partner with Medical Writers and Regulatory teams to ensure all documents meet eSubmissions standards. Key duties include advanced Word formatting, dynamic TOC development, PDF rendering, metadata management, and CSR