Senior Medical Writer - Remote

Overview

The purpose of the Senior Medical Writer is to provide medical writing and scientific services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company.

In Short

• Prepare clinical evaluation reports for submission to regulatory bodies.
• Assist Regulatory Affairs with responses to requests from Regulatory agencies.
• Participate in internal and external audits.
• Perform data analysis of clinical outcomes data.
• Conduct literature reviews according to scientific methodologies.
• Work with functional areas to analyze post-market information.
• Develop risk/benefit analyses.
• Manage multiple medium to large scale writing/research projects.
• Ensure compliance with FDA and ISO guidelines.
• Provide knowledge and support to various business units.

Requirements

• Master’s Degree in a related field required.
• 5 years of Medical/Technical writing skills required.
• Experience in systematic literature review required.
• Experience with EU MDR-compliant post-market reporting preferred.
• Experience in medical devices preferred.
• Understanding of biostatistics preferred.
• Working knowledge of Windows based office productivity tools.

Benefits

• Competitive salary.
• Remote work flexibility.
• Opportunities for professional development.
• Supportive work environment.
• Health and wellness benefits.