Director of Medical Writing - Remote

Overview

The Director of Medical Writing will drive the compilation and preparation of clinical and regulatory documents, collaborating with project teams to support product development and submissions to regulatory authorities.

In Short

• Lead the preparation of clinical and regulatory documents.
• Synchronize timelines and processes for document preparation.
• Communicate deliverables and timelines to the Development team.
• Convert data into scientifically sound documents.
• Work with teams to develop strategies for submissions.
• Provide writing expertise across multiple projects.
• Ensure compliance with regulatory requirements.
• Oversee contract writers and external vendors.
• Foster innovation in medical writing processes.
• Maintain compliance with industry standards.

Requirements

• Master’s degree required; PhD preferred.
• 10 years of experience in medical writing.
• AMWA certification preferred.
• Exceptional writing and editing skills.
• Knowledge of US, ICH, and international regulations.
• Experience with regulatory documentation templates.
• Familiarity with electronic document management systems.
• Ability to interpret and translate scientific data.
• Strong proficiency in word processing and spreadsheets.
• Flexibility to adapt to changing priorities.

Benefits

• Competitive base salary.
• Discretionary bonus eligibility.
• Equity awards based on performance.
• Opportunities for professional development.
• Diverse and inclusive work environment.