Medical Writer

Job Summary

A company is looking for a Medical Writer responsible for developing and managing medical writing deliverables to support clinical regulatory writing.

Key Responsibilities

• Develop strategies and manage projects for regulatory submissions and clinical deliverables
• Coordinate and author regulatory documents, ensuring integration of scientific, medical, and regulatory input
• Produce high-quality documentation in line with regulatory/compliance/scientific requirements

Required Qualifications, Training, and Education

• 10+ years of experience in the research, medical, pharmaceutical, or biotechnology industry
• Minimum of 8+ years of experience as a medical writer in the pharmaceutical and/or biotech industry, focusing on oncology or rare diseases
• Bachelor's Degree required; Advanced Degree preferred
• Technical expertise in Microsoft Office, Adobe Acrobat, and familiarity with document management systems
• Good understanding of global pharmaceutical drug development and regulatory submission requirements