Medical Writing Manager

Job Summary

A company is looking for a Medical Writing Manager to prepare and review clinical and regulatory documents in support of drug development.

Key Responsibilities

• Lead the authoring process for various clinical and regulatory documents
• Represent Medical Writing on project teams and provide subject matter expertise
• Research and implement best authoring practices while training team members

Required Qualifications

• BS/BA in life sciences or related field with 6+ years of medical writing experience, or a Master's degree with 4+ years, or a PhD with 2+ years of relevant experience
• Experience leading NDA/MAA submissions or authoring key supporting documents is preferred
• Strong understanding of the medical writing process and regulatory requirements
• Ability to independently interpret and communicate scientific data
• Experience working with and leading contract medical writers