REMS (Risk Evaluation and Mitigation Strategies) trainings and certifications specific to the site: Tysabri, Lemtrada...
compliance with Baptist Health policies, 340B program (if applicable), accrediting bodies, REMS compliance, third-party payers...
of pharmacy support personnel's work. Ensures compliance with manufacturer requirements for REMS or other requirements when...
, including, pharmaceutical private label products, 3PL, REMS programs, clinical research programs, pharmaceutical and medical...
operations across the US. You will engage in GMP document management and ensure adherence to local regulations, including REMS...
employees. Facilitate research collaborations (including REMS programs, Real World Data [RWD] generation and investigator...
and expand the business. Expert in the areas of specialty pharmacy including REMS products, oncology, hematology... Enforcement Agency, as well as state and local laws and regulations. Detailed understanding of REMS programs relevant...
Evaluations, Signal Evaluation Reports, RSI, PASS, RMPs, REMS, RTDs, PASS, INDs, NDAs, BLAs, and CTAs) Provides medical safety...
journey development particularly for specialty medications (e.g., high cost, biologics, CAR-T, REMs, drug-device combinations...
Evaluations, Signal Evaluation Reports, RSI, PASS, RMPs, REMS, RTDs, PASS, INDs, NDAs, BLAs, and CTAs) Provides medical safety...