Regulatory Medical Writer

Position: Regulatory Medical Writer Needed
Join a team providing critical medical writing services and consultations for clinical research projects. Your expertise in regulatory documents and communication will drive impactful results.

This role focuses on delivering high-quality medical writing for Clinical Research Scientists, academic partners, and sponsors. You will research, write, and review essential documents, including protocols and clinical study reports. Your project management skills will ensure timely and compliant document submissions while maintaining quality standards throughout the process.

Key Responsibilities:

• Lead planning and production of regulatory documents

• Coordinate specialized content with authors and technical specialists

• Act as the primary contact for publication-related inquiries

• Perform quality control reviews for other authors’ documents

• Support teams with editing study documents as requested

Requirements:

• Bachelor’s degree with 3-5 years in medical writing

• Experience in protocol and clinical report development

• Trained in GCP, GDPR, and HIPAA

• Strong written and verbal communication skills

• Familiarity with ICH M11 and AMA Style Guide

Leverage your medical writing expertise to enhance research deliverables and build important collaborations.