Document Specialist

Job Summary

A company is looking for a Document Specialist responsible for formatting and processing regulatory documents to support electronic publishing activities.

Key Responsibilities

• Formats, reviews, and compiles regulatory documents for electronic submissions, ensuring compliance with client specifications
• Performs document conversion to PDF and ensures eCTD compliance through quality checks and adherence to guidelines
• Manages multiple projects simultaneously while maintaining communication with clients and ensuring timely completion

Required Qualifications

• Minimum 3 years of experience in document publishing and/or formatting
• Pharmaceutical/biotech industry experience preferred, particularly with INDs, CTAs, NDAs, BLAs, and MAAs
• Fluency in English
• Extensive knowledge of Microsoft Word and Adobe Acrobat
• Experience with eCTD publishing systems and regulatory document tools