Principal Medical Writer

Job Summary

Leading the authorship of regulatory documents, the full-time Principal Medical Writer will manage client engagements and mentor junior writers while working remotely to streamline the regulatory documentation process.

Key responsibilities

• Oversee the creation and authorship of various regulatory documents across multiple service lines
• Act as project leader for client engagements, ensuring clarity of purpose and adherence to timelines and budgets
• Mentor and guide junior writers in regulatory writing best practices and document creation processes

Required qualifications

• Bachelor's degree or higher
• 7+ years of experience in regulatory writing, specifically with clinical-related documentation
• Strong understanding of regulatory requirements and global health authority guidelines
• Experience leading the authorship of study and submission-level documents
• Proficiency in Microsoft Word and document management techniques