Principal Medical Writer

Job Summary

Working remotely in a full-time capacity, the Principal Medical Writer will independently plan and prepare regulatory documents and medical communications to support product development, collaborating with cross-functional teams while ensuring compliance with ICH and regulatory guidelines.

Key responsibilities

• Organize, analyze, interpret, and present scientific and statistical information for regulatory submissions
• Lead submission-level sections of clinical documents, ensuring clarity and adherence to timelines and budgets
• Collaborate with internal and external teams to produce high-quality medical writing deliverables across various therapy areas

Required qualifications

• Bachelor's degree, 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 Microsoft Word skills
• Broad experience across multiple therapy areas with the ability to transfer knowledge within the organization