Senior Medical Writer

Job Summary

A company is looking for a Senior Medical Writer to provide medical writing support for regulatory submissions.

Key Responsibilities

• Author and project manage contributions for regulatory submissions, ensuring compliance with medical writing standards
• Develop content for phase 1-4 protocols, master ICFs, IBs, and CSRs
• Ensure inspection-readiness of medical writing activities and support project teams to meet deadlines

Required Qualifications

• Bachelor's degree in a scientific or clinical discipline; Ph.D. preferred
• Minimum of 3 years of sponsor-level pharma or biotech clinical/regulatory medical writing experience
• Native/bilingual or fluent American English proficiency
• Basic understanding of scientific methodology as applied to drug development
• Familiarity with pharmacovigilance guidelines and developing aggregate reports