Principal Medical Writer

Job Summary

A company is looking for a Principal Medical Writer who independently plans and prepares regulatory documents and medical communications to support product development.

Key Responsibilities

• Organize, analyze, interpret, and present scientific and statistical information in compliance with regulatory guidelines
• Collaborate with cross-functional internal and external document production teams
• Prepare a range of regulatory documents and medical communications for all phases of product development

Required Qualifications, Training, and Education

• 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
• Experience with Microsoft Office Suite, particularly advanced proficiency in Microsoft Word