What are the responsibilities and job description for the Medical Writer position at A2-Ai LLC?
About A2-Ai
A2-Ai is a premier full service Clinical Pharmacology Consultancy Service Provider run by leaders who put the science and patients first. Supporting all phases of drug development, we provide end-to-end technical solutions to our clients including 1) Clinical Pharmacology 2) Pharmacometrics and 3) AI solutions. We tailor the resources needed to support client assets and guarantee industry leading high-quality standards. Our leadership has many years of experience within the field and has supported many successful regulatory submissions.
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.
Benefits:
- A2-Ai provides top of the industry benefits including 401(k) with company contributions, fully funded health insurance without employee premiums, employer funded HSA, and 20 days of paid time off.
Compensation:
- Commensurate with credentials. $60,000.00 to $100,000.00
- Eligible for bonus considerations.
Job Type: Full-time
Pay: $60,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- Health insurance
- Health savings account
- Paid time off
- Parental leave
- Relocation assistance
Schedule:
- 8 hour shift
Work Location: In person
Salary : $60,000 - $100,000
