Regulatory Document Specialist

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

Job title: Regulatory Document Specialist/Medical Writing Word Processing Coordinator II

Duration: 12 Months, extension or conversion potential based on business need and performance

Work Arrangement: 100% Remote (US-based; must align with core team business hours)

Interview Process: 1 Virtual Interview Round

Position Overview:

The Medical Writing Word Processing Coordinator II provides technical document formatting, style compliance, and submission-readiness support for clinical and regulatory documentation (including Clinical Study Reports and CSR Appendices). Working as a technical partner to Medical Writers and cross-functional teams (Clinical Development, Regulatory Affairs, Safety), this role ensures all deliverables meet stringent eSubmissions standards, follow established templates, and cleanly convert into submission-ready PDFs.

This position is strictly centered on hands-on document formatting, styling, and technical PDF generation. It is not a content-writing, medical writing, or line-editing role. Candidates must prioritize technical formatting speed, accuracy, and efficiency over substantive textual review.

Key Responsibilities:

• Advanced Document Formatting: Apply standard master and redesign styles, standardize layouts, and format complex multi-page clinical/regulatory documents in Microsoft Word.
• Navigation & Structural Elements: Build and troubleshoot dynamic Tables of Contents (TOC), cross-references, bookmarks, hyperlinks, headers/footers, and complex data tables.
• PDF Rendering & Submission Readiness: Generate, review, and QC PDFs from MS Word to verify that all links, bookmarks, pagination, and fonts render properly according to electronic Common Technical Document (eCTD) specifications.
• Document Management & Routing: Import, route, and track documents within Regulatory Information Management Systems (RIMS) and electronic document management repositories.
• CSR Appendix & Lifecycle Support: Coordinate and verify the completeness, structure, and compilation of Clinical Study Report (CSR) appendices.
• Metadata & Compliance: Accurately populate document properties, maintain standardized file-naming conventions, and verify standard literature citations.
• Technical Issue Resolution: Troubleshoot corrupted styles, broken cross-references, table misalignments, and rendering discrepancies in high-priority submission documents.
• Stakeholder Coordination: Communicate deliverable timelines, flag formatting discrepancies or obvious document defects directly to authors/medical writers, and support centralized intake mailboxes.

Must-Have Technical Qualifications:

• Advanced Microsoft Word Mastery: Deep operational proficiency with Word templates, built-in and custom style palettes, multi-level numbering, section breaks, automated fields, and layout troubleshooting.
• PDF Generation & Quality Control: Hands‑on experience producing and validating eSubmissions-compliant PDFs (using Adobe Acrobat Professional or equivalent regulatory toolsets).
• Document Production Focus: Demonstrated track record where daily responsibilities were centered on formatting and technical document preparation rather than content generation.
• Experience working with Regulatory Information Management Systems (RIMS) or electronic Document Management Systems (eDMS) such as Veeva Vault, Cosmos, Documentum, or similar platforms.
• Familiarity with ICH/eCTD guidelines, regulatory submission workflows, and clinical document structures (e.g., protocols, investigator brochures, CSRs).
• 3+ years of experience in regulatory operations, document publishing, or technical word processing within the pharmaceutical, biotech, or contract research organization (CRO) sectors.

Education & Experience Guidelines:

• Education: High School Diploma, Associate Degree, or Bachelor's Degree (Life Sciences, English, Communications, or related discipline). Practical, verifiable formatting expertise heavily outweighs specific degree levels.
• Experience Range: Open to qualified candidates across experience tiers (from 3–5 years up to senior specialists with 15+ years), provided the candidate is comfortable with an execution-focused formatting workload.
• Target Profiles / Prior Titles: Regulatory Publisher, Document Formatter, Regulatory Document Specialist, Document Production Specialist, Word Processing Specialist, or Technical Writer/Editor with heavy formatting ownership.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.