Principal Strategic Medical Writer

📋 Description

• Lead and write clinical and regulatory documents for drug/device development.
• Coordinate review, approval, and quality control of documents.
• Manage timelines and communicate deliverables to the team.
• Drive submission objectives and project management strategies.
• Develop knowledge of US/international regulatory guidance.
• Apply therapeutic area knowledge to projects and improvements.

🎯 Requirements

• 5+ years in bio-pharmaceutical industry delivering medicines/therapies.
• Bachelor’s degree or higher; scientific discipline preferred.
• Outstanding written and oral communication; strong scientific terminology.
• Experience writing/editing clinical/regulatory docs; ICH, GCP, CONSORT/PRISMA knowledge.
• Drug development, clinical research, study designs, biostatistics, regulatory terms.
• Excellent writing; ability to manage multiple projects with cross-functional teams.

🎁 Benefits

• Paid time off (vacation, holidays, sick).
• Medical/dental/vision insurance.
• 401(k) eligibility.