to Investigator Brochures, DSURs, Protocols, ICFs, IBs (including RSI determination), CSRs, CCDS, RMP, REMS etc. Assist...
of pharmacy support personnel's work. Ensures compliance with manufacturer requirements for REMS or other requirements when...
employees. Facilitate research collaborations (including REMS programs, Real World Data [RWD] generation and investigator...
operations across the US. You will engage in GMP document management and ensure adherence to local regulations, including REMS...
reconciliation documents, CTD modules, REMS, RMP and CSR). Essential Functions: Manages all medical aspects of contracted tasks... and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules...
from other groups, review coordination, and quality checks. Coordinate RMP updates and REMS reports as appropriate. Support regulatory...
for free drug via manufacturer assistance programs. Serves as the subject matter expert for oral oncolytic REMS programs...
, additional risk minimization measure materials, Structured Benefit Risk Assessments, REMS documents and REMS materials...
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...