Principal Medical Writer

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Lead authoring and strategic planning for clinical and regulatory documents, including protocols, clinical study reports, briefing documents, and submission dossiers.
• Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards.
• Translate complex clinical and statistical data into clear, accurate, and well-structured scientific narratives for diverse audiences.
• Act as a subject matter expert on medical writing standards, document structure, and regulatory expectations.
• Drive process improvement initiatives, support KPI tracking, and contribute to audit readiness and compliance activities.

Qualifications

• Bachelor’s degree in life sciences, health sciences, or a scientific field.
• 5+ years of experience in medical or regulatory writing within the pharmaceutical or healthcare industry.
• 3+ years of experience with regulatory dossier development and Common Technical Document (CTD) module documents.
• 3+ years of experience independently authoring clinical protocols, clinical study reports, and regulatory submission documents.