Experienced proofreader needed with pharmaceutical labeling and packaging experience to proofread/edit product labels.
· Collaborate with Regulatory Therapeutic Labeling Leads to strategically proof US Rx brand, generic, and device labeling and artwork for packaging components in electronic artwork system for accuracy and compliance
· Review US labeling documents to ensure alignment with FDA regulations in 21 CFR and FDA’s Guidance for Industry for Physician Labeling Rule (PLR) and other applicable guidance documents
· Maintain and update Structured Product Labeling (SPL) files for compliance with FDA regulations and with FDA’s Guidance for Industry for SPL
· Posted SPL to DailyMed and the FDA website to provide accurate and timely information to customers and the agency Note - SPL experience preferred, but not required