Senior Medical Writer

Job Summary

Leading the preparation of clinical and regulatory documents, the full-time Senior Strategic Medical Writer will work remotely to support drug and device development while ensuring compliance and quality throughout the project lifecycle.

Key responsibilities:

• Prepares and maintains clinical and regulatory documents, coordinating quality control and review processes
• Develops knowledge of submission strategies and regulatory requirements, participating in process improvements
• Collaborates with cross-functional teams to address inquiries and ensure an inspection-ready approach

Required qualifications:

• A minimum of 4+ years of experience in the bio-pharmaceutical industry, focusing on drug development and regulatory documentation
• Bachelor's Degree or higher in a scientific discipline
• Experience with ICH guidelines, GCP, and familiarity with CONSORT and PRISMA standards
• Understanding of clinical research, study designs, and biostatistics
• Excellent writing skills with the ability to communicate complex scientific information effectively