Medical Director/Sr Medical Director - Rheumatology
Core
Provides medical oversight of clinical trials and marketed products to ensure regulatory compliance and safety, serving pharmaceutical clients and biotech partners.
Role type
Senior Medical Director (Pharmacovigilance & Clinical Trials)
Builds
Clinical trial deliverables (CSRs, safety reports, CTD modules) and marketed product safety dossiers
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Medical judgment, safety data analysis, regulatory guideline interpretation, therapeutic expertise, signal detection, report writing
Preferred skills
Active medical licensure, mentorship, biostatistics knowledge, data management
Technologies
Medra, safety databases
Responsibilities
Provide medical consultation to clients and investigators; Review and analyze serious adverse events and periodic safety reports; Monitor safety variables in clinical studies; Manage signal detection activities for marketed products; Assist in writing and reviewing clinical study reports and regulatory documents.
Seniority
Senior, hands-on IC with mentorship