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 with industry standards and project timelines.

Key responsibilities:

• Prepares and maintains clinical and regulatory documents, coordinating reviews and quality control with cross-functional teams
• Develops knowledge of submission strategies and participates in tactical process improvements to enhance documentation quality
• Collaborates with leadership and R&D Quality Assurance to address inquiries and ensure an inspection-ready approach

Required qualifications:

• A minimum of 4+ years of experience in the bio-pharmaceutical industry, with a focus on global pharma or biotech
• Bachelor's Degree or higher in a scientific discipline is preferred
• Experience writing and editing clinical and regulatory documents in accordance with ICH guidelines and GCP
• Strong understanding of drug development, clinical research, and regulatory requirements
• Proven ability to manage multiple projects and collaborate effectively with cross-functional teams