Remote Regulatory Document Formatter, CSR & Word Processing

Orion Group; United States; Remote; USD 83,097,000 - 100,124,000; Full time

Job summary

Orion Group is seeking a Medical Writing Operations Formatter to provide document formatting and CSR appendix coordination for regulatory submissions. This remote role supports Medical Writing and Regulatory Information Management Systems.

You will apply Word styles, format CSR appendices, verify literature citations, and ensure documents meet templates and deadlines across functional teams.

Qualifications

• Knowledge of Microsoft Word styles and regulatory document formatting standards.
• Knowledge of CSR and CSR appendix organization and content, including CTD structure.
• Knowledge of RIMS and eSubmissions styles, document processing, publishing, and file naming conventions.

Responsibilities

• Define the scope of document formatting or CSR appendix activities with the document author.
• Process, proofread, verify, and manage clinical regulatory documents to ensure submission readiness.
• Format, import, route, and publish documents in RIMS within required timelines.
• Apply RIMS and eSubmissions styles and formatting standards.
• Populate document properties and apply correct RIMS/eSubmissions naming conventions.
• Ensure CSR appendices contain complete information and support coordination and content.
• Communicate deliverables, timelines, completion dates, issues, and conflicts to stakeholders.
• Provide ongoing support to Medical Writing and related teams; liaise between eDocs support and Medical Writing.
• Serve as SME for master file system, formatting, and report publishing for Medical Writing stakeholders.
• Verify literature citations and perform literature searches.
• Contribute to development and maintenance of Medical Writing Operations processes.
• Assist with centralized mailbox, metrics, and training documents.

Skills

Word styles

CSR formatting

RIMS

eSubmissions

Document publishing

Literature citation verification

Communication

Education

Bachelor of Science in English or Communications

Tools

Microsoft Word

Job description

Orion Group is seeking a Medical Writing Operations Formatter to provide document formatting and CSR appendix coordination for regulatory submissions. This remote role supports Medical Writing and Regulatory Information Management Systems.

You will apply Word styles, format CSR appendices, verify literature citations, and ensure documents meet templates and deadlines across functional teams.