Associate Director, Medical Writing - Remote

Overview

The Associate Director, Medical Writing is responsible for the timely preparation of high quality, compliant clinical and regulatory documents for Dyne Therapeutics, focusing on improving the lives of individuals with genetically driven neuromuscular diseases.

In Short

• Write, edit, and collaborate on regulatory documents.
• Review and ensure quality of documents prepared by others.
• Oversee document review comment resolution meetings.
• Contribute to project management and cross-functional working groups.
• Support development of best practices for authoring and reviewing.

Requirements

• Bachelor’s degree in Life Sciences or related discipline.
• Minimum 5 years of experience in medical writing.
• Competence in writing and reviewing clinical regulatory documents.
• Knowledge of FDA regulations and ICH guidelines.
• Proficiency in Microsoft Office and document management systems.
• Ability to work independently and prioritize tasks.
• Aptitude for data compilation and presentation.
• Commitment to accuracy and detail-oriented work.

Benefits

• Hybrid work flexibility.
• Opportunity to impact lives through innovative therapeutics.