Medical Writing Operations Formatter

Job Summary

Detail-oriented and experienced, the Medical Writing Operations Formatter will work remotely on a contract basis for one year, collaborating with Medical Writers and regulatory teams to format, review, and maintain submission-ready clinical documents and CSR Appendices within Regulatory Information Management Systems (RIMS).

Key responsibilities

• Format, import, route, and publish clinical regulatory documents in RIMS, ensuring compliance with templates and eSubmission standards
• Coordinate and verify the completeness of CSR Appendices, applying proper document properties, metadata, and file-naming conventions
• Serve as a Subject Matter Expert (SME) on master file systems, formatting standards, and CTD structure for cross-functional stakeholders

Required qualifications

• Bachelor's degree (BS or BA in English/Communications considered)
• 3 to 5 years of relevant pharmaceutical or biotech industry experience in medical writing, regulatory, quality, or clinical research
• Strong proficiency in MS Word formatting, eSubmission standards, CTD structure, and electronic document publishing
• Proven organizational, time management, and interpersonal communication skills