Regional Director - Neurology-New York Metro
Experience in complex therapies (REMS, Biologics, specialty pharmacy) in the Rare Disease or Neurology field highly preferred ie...
Experience in complex therapies (REMS, Biologics, specialty pharmacy) in the Rare Disease or Neurology field highly preferred ie...
Qualifications: Experience with FDA Risk Evaluation and Mitigation Strategies (REMS) preferred. Demonstrated experience...
Qualifications: Experience with FDA Risk Evaluation and Mitigation Strategies (REMS) preferred. Demonstrated experience...
/provided. Is proficient in Rems, Altheas, Rapid Result Tests (UDS), PFT, EKG, TMS, AIMS Testing, Med reconciliation & refills...
working within Salesforce.com Experience with REMS product(s) Experience with limited distribution product(s) MINIMUM...
/Experience Phase 3b/4 and post-approval dedication research including overseeing patient registries and REMS programs...
, meeting REMS, FDA, and manufacturer program requirements Provide high-touch patient support, addressing non-clinical...
analysis of the safety data and authoring of some sections (Development Risk Management Plan [DRMP], RMP, REMS, etc.) Prepare...
compliance with REMS and accreditation standards, including documentation and reporting requirements Support quality initiatives...
(including DSURs, PADERs and PBRERs) Contributes to the writing and/or review of the RMP/REMS documents and their maintenance...