1 Year Temporary Contract - Medical Operations Regulatory Junior Analyst
Core
Support the Medical Operations Regulatory Manager in preparing, negotiating, and executing Clinical Studies Agreements for AbbVie-sponsored clinical studies, including field support for study submissions, managing interactions with Ethics Committees (ECs) and Administration Offices (AOs), and handling Compassionate Use (PAA) program requests.
Role type
Junior Regulatory Analyst (Medical Operations)
Builds
Clinical Studies Agreements, study submission updates, IIS management system records, and Compassionate Use drug resupply processes.
Domain
Clinical Research / Pharmaceutical Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory and ethical aspects knowledge, document archiving, matrix organization navigation, English (B1), medical/science/legal degree
Preferred skills
Compassionate use experience, 6+ months regulatory experience, PhD or specialty degree
Technologies
IIS management systems