MD, PhD, or PharmD: 0 to 3 years with industry experience in clinical development and bioequivalence (BE) clinical trial management or similar experience in university, hospital or research organization
MS: 3 to 5 years of clinical development/clinical trial management
BS: 5 to 8 years with industrial or CRO clinical experience
Experience in writing clinical portions of regulatory dossiers highly preferred
Knowledge of drug development (all clinical research process including protocol and case report form design, etc)
Knowledge of GCP/ICH guidelines and FDA regulations
Desired Qualifications
Writing clinical portions of regulatory dossiers highly preferred
Job Description
Qualifications
MD, PhD, or PharmD: 0 to 3 years with industry experience in clinical development and bioequivalence (BE) clinical trial management or similar experience in university, hospital or research organization • MS: 3 to 5 years of clinical development/clinical trial management • BS: 5 to 8 years with industrial or CRO clinical experience
Experience in writing clinical portions of regulatory dossiers highly preferred • Knowledge of drug development (all clinical research process including protocol and case report form design, etc) • Knowledge of GCP/ICH guidelines and FDA regulations