Medical Assistant
as a Medical Assistant in an outpatient clinical setting Comfort using EMR/EHR systems (ModMed/EMA a plus) Preferred...
as a Medical Assistant in an outpatient clinical setting Comfort using EMR/EHR systems (ModMed/EMA a plus) Preferred...
and executing IQ, OQ, and PQ documentation. Strong technical writing and documentation skills. Experience working under FDA, EMA...
between Emergency Management Agency (EMA), University of Alabama, local/state/federal governments, citizens, elected officials...
audiences (internal and external). Knowledge of medical affairs processes, regulatory compliance (GCP, FDA/EMA...
working with multiple regulatory health authorities (e.g. FDA, EMA, TGA, MHRA, PMDA, HC, etc.) Familiarity with ICH and FDA...
). Strong understanding of GMP/GxP requirements for large molecule commercial reagents as per global agency (e.g., FDA, EMA...
, clinical evaluation reports, and scientific publications. Ensure compliance with ICH GCP, FDA/EMA guidelines, and internal...
or Bayesian approaches) Experience in leading to answer health authority questions (FDA, EMA) and leading in statistics...
Selection, and Approvals and Continuous Improvement. Provides support and interfaces directly/indirectly with the FDA, EMA, MHRA...
knowledge of PV regulations: FDA (21 CFR 312.32, 314.80, FAERS), EMA GVP (Modules VI, VII, IX), and ICH E2 (E2A-E2F). Direct... (Big 4 or life sciences consultancies) in PV projects. Involvement in regulatory inspections (FDA/EMA GVP), and audit...