Remote Medical Writing Operations Specialist

The Fountain Group; United States; Remote; USD 45,000 - 48,000; Full time

Job summary

The Fountain Group is seeking a detail-oriented Medical Writing Operations Formatter to support formatting and publishing of clinical and regulatory documents for a prominent client. This remote role collaborates with Medical Writers, Clinical Research, Regulatory Affairs, and other teams to meet formatting standards and submission deadlines.

Responsibilities include formatting, proofreading, CSR preparation, handling RIMS/eSubmissions, maintaining CTD knowledge, and ensuring accurate PDFs for

Qualifications

• 3–5 years of relevant pharmaceutical/biotech experience.
• Experience formatting clinical/regulatory documents for electronic submission.
• Familiarity with CSRs and CSR Appendices.
• Experience with RIMS or electronic document management systems.
• Knowledge of CTD structure and regulatory submission standards.

Responsibilities

• Format, proofread, review, and prepare clinical and regulatory documents for submission readiness.
• Support CSR and CSR Appendix preparation and organization.
• Import, format, route, track, and publish documents in RIMS/eSubmissions.
• Ensure documents comply with templates, formatting standards, and submission requirements.
• Apply document styles, properties, and naming conventions for consistency across submissions.
• Maintain proper formatting of Word docs and PDFs for electronic submission.
• Stay up-to-date on CTD structure and regulatory publishing requirements.
• Collaborate with writers and cross-functional teams on formatting deliverables and timelines.
• Coordinate with stakeholders to resolve formatting issues and publishing challenges.

Skills

Detail-oriented

Communication skills

Organizational skills

Education

Bachelor's degree in a relevant field (Science, English, Communications)

Tools

Microsoft Word Advanced Formatting

PDF preparation

RIMS / eSubmissions platforms

Document management systems

Job description

The Fountain Group is seeking a detail-oriented Medical Writing Operations Formatter to support formatting and publishing of clinical and regulatory documents for a prominent client. This remote role collaborates with Medical Writers, Clinical Research, Regulatory Affairs, and other teams to meet formatting standards and submission deadlines.

Responsibilities include formatting, proofreading, CSR preparation, handling RIMS/eSubmissions, maintaining CTD knowledge, and ensuring accurate PDFs for