Principal Medical Writer

Job Summary

Working fully remote, the full-time Principal Medical Writer will independently plan and prepare regulatory documents and medical communications, organizing and presenting scientific information in accordance with industry guidelines while collaborating with cross-functional teams.

Key responsibilities

• Independently plan and prepare a range of regulatory documents and medical communications
• Organize, analyze, interpret, and present scientific and statistical information according to industry guidelines
• Collaborate with internal and external document production teams as directed by Medical Writing management

Required qualifications

• Bachelor's degree required; PhD, MD, or PharmD preferred in a science-related field
• Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology setting
• Experience as a lead writer on at least 20 manuscripts, abstracts, and presentations across all drug development phases
• Advanced knowledge of ICH and related regulatory guidelines; ISMPP CMPP certification preferred
• Proficiency in MS Office Suite and Adobe Acrobat for document preparation and editing