The Associate Director, Medical Writing and AI Implementation will support the Medical Writing function at Lexeo, generating and managing clinical and regulatory documents, and implementing AI tools to drive optimization and efficiency. This role will be responsible for planning, development, and oversight of study and program level documents, managing medical writing and regulatory operations resources, and contributing to process improvement initiatives.
Requirements
- Draft and contribute to the development of high-quality submission-ready documents such as protocols, protocol amendments, clinical study reports, and others.
- Ensure the quality of deliverables by conducting editorial reviews of documents and completing or managing the quality checking of documents according to Lexeo standards.
- Manage the document development process for deliverables, including planning aspects, project execution, and project finalization.
- Publish documents for submission and/or oversee Regulatory Operations vendors as needed and review published documents prior to submission.
- Use AI and automation to support publishing activities such as document formatting, hyperlinking, and validation checks.
- Use AI capabilities and implement new AI of appropriate scope to improve efficiencies and optimize processes of all activities related to Regulatory and Medical Writing.
- Act as the lead for training the medical writing (and regulatory and clinical development as appropriate) team(s) on new AI/digital tools and updated workflows.
- Continuously monitor emerging trends and best practices in medical writing and AI.
- Propose and lead process improvement initiatives that enhance document quality or team productivity.
- Identify and implement organizational efficiencies for document development and quality, document management, and submission management.
- Serve as a StartingPoint Administrator, managing template upgrades, internal user support, and cross-departmental training.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
