Medical Director/Senior Medical Director - Nephrology (FSP)
Core
Provide medical oversight of clinical trials and marketed products, ensuring adherence to regulations and client directives while managing safety data and therapeutic expertise.
Role type
Senior IC Medical Director (Pharmacovigilance/Clinical Trials)
Builds
Clinical trial deliverables, safety reports, regulatory dossiers, and risk management activities for pharmaceutical clients
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Medical judgment, safety data analysis, regulatory compliance, therapeutic expertise, protocol interpretation, signal detection, report writing
Preferred skills
Active medical licensure, biostatistics knowledge, data management familiarity, clinical operations understanding
Technologies
Medra, safety databases
Responsibilities
Manage medical aspects of contracted tasks across the pharmaceutical product life-cycle; Monitor safety variables and review adverse events; Provide medical consultation to investigators and clients; Assist in writing and reviewing clinical study reports and safety documents; Manage signal detection activities and support label updates
Seniority
Senior, hands-on IC