Associate Director, Medical Writing and AI Implementation - Remote

Overview

The Associate Director, Medical Writing will support the Medical Writing function at Lexeo, working cross-functionally to generate and manage the development of clinical and regulatory documents. This role will also take a lead in implementing artificial intelligence (AI) tools to drive optimization and efficiency in all aspects of regulatory and medical writing.

In Short

• Draft and contribute to high-quality submission-ready documents.
• Conduct editorial reviews of documents for quality assurance.
• Manage document development processes and timelines.
• Publish documents and oversee vendor management.
• Implement AI tools to enhance writing efficiency.
• Research and evaluate AI-powered tools for regulatory writing.
• Drive integration of AI technologies into daily activities.
• Lead training for teams on new AI tools.
• Monitor trends in medical writing and propose improvements.
• Oversee vendor engagement and management.

Requirements

• Bachelor's degree required; graduate degree preferred.
• Minimum of 8 years experience in medical writing.
• Experience with AI tools in a regulatory setting preferred.
• Direct experience in developing clinical and regulatory documents.
• Knowledge of eCTD and document publishing specifications.
• Thorough knowledge of drug development processes.
• Advanced writing and communication skills.
• Experience with complex regulatory documents.
• High attention to detail and ability to manage multiple projects.
• Proficiency in Microsoft Office and Adobe Acrobat.

Benefits

• Opportunity to lead innovative projects in medical writing.
• Work with cross-functional teams and external vendors.
• Professional development in AI and regulatory writing.
• Contribute to process improvement initiatives.
• Dynamic and collaborative work environment.