Medical Writing Operations Formatter

Job Summary

Detail-oriented and experienced, the Medical Writing Operations Formatter will work remotely on a contract basis to support the preparation, formatting, and publishing of clinical and regulatory documentation within the pharmaceutical industry.

Key Responsibilities

• Format, proofread, and prepare clinical and regulatory documents to ensure accuracy and submission readiness
• Support the organization and completeness of Clinical Study Reports (CSRs) and CSR Appendices
• Import, format, and publish documents within Regulatory Information Management Systems (RIMS)

Required Qualifications

• Bachelor's degree in a relevant field such as Science, English, or Communications
• 3-5 years of relevant experience in pharmaceutical, biotechnology, or clinical research
• Experience formatting clinical or regulatory documents for electronic submission
• Strong proficiency in Microsoft Word, including advanced formatting skills
• Knowledge of regulatory submission standards and Common Technical Document (CTD) structure