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...
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...
of requirements of specific clinical programs as per policy and procedures. (REMS, IgG, Hemophilia, etc.) Participate in center QA...
, Procurement, REMS) to ensure informed decision-making. Implement Work Breakdown and Project Coding Structures, collect...
. · New product launch experience preferred · Specialty pharmacy/REMS experience preferred This position's reasonably...
, formulary request process and presentation to P&T committee(s), evaluate off label/exception review, REMS programs...
for FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) education and onboarding. You'll facilitate the procedural progression.... Your responsibilities will include conducting patient case reviews, managing outstanding requests, and ensuring compliance with REMS...
for FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) education and onboarding. You'll facilitate the procedural progression.... Your responsibilities will include conducting patient case reviews, managing outstanding requests, and ensuring compliance with REMS...