Principal Medical Writer

📋 Description

• Lead medical writing on complex publications and regulatory documents for filings and dossiers.
• Collaborate with cross-functional teams (Regulatory, PK, Toxicology, Data Management, Publishing)
• Mentor junior writers and recommend process improvements to writing systems.
• Translate scientific data into audience-appropriate formats for journals and submissions.
• Coordinate reviews, approvals, and audit responses with Regulatory Quality Assurance.

🎯 Requirements

• Bachelor's degree in English/Communications with science background or Life Science with writing
• 3-4 years in medical writing or related areas; AMWA certification preferred.
• Expert knowledge of US/international regulations for scientific publications and submissions.
• Strong editing/writing skills, attention to detail, and ability to work cross-functionally.
• Proficiency with journal/congress requirements, ICH guidelines, and electronic submission standards.
• Experience with eCTD, COSMOS, and electronic document management systems.

🎁 Benefits

• Competitive compensation range related to location.
• Comprehensive benefits package including PTO and 401(k).
• Eligibility to participate in long-term incentive programs.