Ensure scientific support for operational realization for assigned study/studies or registries by securing the operationalization of the medical validation/review plan (reports and trackers)
Contribute to preparation and/or review of documents requiring scientific background (abbreviated protocol/protocol/amended protocol, patient written information, presentations, study plans, study reports, trial disclosure forms)
Support CRD in preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, and experts
Support study data validation and review processes

Requirements

Advanced degree (PharmD, PhD, or Master's degree) in life sciences, pharmacy, or related field
1-2 years of clinical development experience in pharmaceutical/biotech industry preferred
Strong knowledge of GCP, ICH guidelines, and regulatory requirements (FDA, EMA)
Understanding of clinical trial processes and adverse event reporting

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical developmentmedical validationdata validationdocument preparationprotocol reviewadverse event reporting

Soft Skills

communicationcollaborationattention to detail

Certifications

PharmDPhDMaster's degree