Medical Writer

A2-Ai LLC • Ann Arbor, MI

419d • $60,000 - $100,000

About The Position

A2-Ai is seeking a highly motivated medical writer to join their team. The role involves collaborating with pharmacometricians to prepare analysis plans, modeling and simulation reports, and regulatory submission documents for drug development programs. The medical writer will ensure compliance with regulatory guidelines and facilitate the review and approval process of reports.

Requirements

• Bachelor of Science in a scientific discipline (e.g., Biology, Chemistry, Pharmacology).
• Excellent writing and communication skills.
• Mid-level analysis skills.
• Leadership abilities.
• Knowledge of medical terminology.
• Familiarity with FDA regulations.

Nice To Haves

• Experience with population PK/PD analysis.
• Experience in regulatory writing and knowledge of regulatory guidelines (e.g., FDA, EMA).

Responsibilities

• Prepare analysis plans and reports for 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 in the preparation of manuscripts for journal submissions and/or posters for professional meetings.

Benefits

• 401(k) with company contributions
• Fully funded health insurance without employee premiums
• Employer funded health savings account (HSA)
• 20 days of paid time off
• Parental leave
• Relocation assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree