with the oncology and REMS programs. Ensures medically appropriate, high quality, cost-effective care and appropriateness...
regional infusion site strategy and oversee its implementation. Ensure compliance with REMS program, medical and site of care... policies, including REMS certification. Provide education and support on billing/coding, coverage/payment, and clinical...
/concerns with MSLs and key internal stakeholders. REMS training with Authorized Representative Perform supplemental...
in development and maintenance of risk management plans and REMS as applicable. Key member on the Product Safety Committee...
, including, pharmaceutical private label products, 3PL, REMS programs, clinical research programs, pharmaceutical and medical...
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...
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...