Medical Writer

Position overview

A2-Ai is currently seeking a highly motivated medical writer to join our team. The medical writer will work with pharmacometricians to prepare analysis plans, modeling and simulation reports and regulatory submission documents for our clients’ drug development programs.

Specific responsibilities

• Prepare analysis plans and reports (internal reports for client as well as submission-ready reports) of modeling and simulation results.
• Facilitate the report review and approval process.
• Coordinate activities for the quality control (QC) of results against original source documents.
• Comply with 21CFR11 regulations to maintain an audit trail of all reported results.
• Maintain working knowledge of regulatory agency guidelines and requirements.
• Prepare regulatory response documents as requested.
• Participate with client and A2-Ai pharmacometricians in the preparation of manuscripts for journal submissions and/or posters for presentation at professional meetings.

Qualifications

• BS or higher in a scientific discipline (e.g., Biology, Chemistry, Pharmacology).
• Excellent communication skills and ability to collaborate effectively with cross-functional teams.
• Experience with population PK/PD analysis is a plus.
• Experience in regulatory writing and knowledge of regulatory guidelines (e.g., FDA, EMA) is desirable.