Medical Director/Senior Medical Director - Rheumatology/Dermatology
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
Therapeutic expertise in rheumatology or dermatology, clinical trial management, safety data analysis, regulatory guideline knowledge (FDA, ICH, EMA, GCP), medical consultation, report writing (CSR, ICSR, PSUR, DSUR, RMP, REMS, CTD)
Preferred skills
Active medical licensure, experience as principal investigator, biostatistics knowledge, data management proficiency
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 and safety reports; manage signal detection activities and support label updates
Seniority
Senior, hands-on IC
