Principal Medical Writer

Job Summary

Independently planning and preparing regulatory documents and medical communications, the full-time Principal Medical Writer will support all phases of product development while working remotely and collaborating with cross-functional teams.

Key responsibilities

• Organize, analyze, interpret, and present scientific and statistical information in compliance with ICH and regulatory guidelines
• Collaborate with internal and external document production teams to ensure high-quality deliverables
• Prepare a range of regulatory documents to support product development initiatives

Required qualifications

• Bachelor's degree required, preferably in a science-related field
• Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology setting
• Advanced knowledge of ICH and related regulatory guidelines
• Proficiency in Microsoft Office Suite, particularly advanced skills in Microsoft Word
• Strong interpersonal and communication skills