Senior Regulatory Medical Writer

Job Summary

A company is looking for a Senior Regulatory Medical Writer to lead and manage the writing of clinical regulatory documents.

Key Responsibilities

• Collaborate with internal teams to write and manage clinical regulatory documents
• Coordinate review cycles and lead data interpretation and comment resolution meetings
• Ensure compliance with regulatory standards and conduct quality control reviews

Required Qualifications

• Bachelor's Degree required; advanced degree preferred
• A minimum of 5 years of experience as a medical writer in the pharmaceutical industry
• Experience with regulatory documents such as clinical study reports and marketing applications
• Solid knowledge of FDA, EMA, and ICH guidelines
• Technical proficiency with Microsoft Office, Adobe Acrobat, and document management systems