Senior Therapy Access Manager
working within Salesforce.com Experience with REMS product(s) Experience with limited distribution product(s) MINIMUM...
working within Salesforce.com Experience with REMS product(s) Experience with limited distribution product(s) MINIMUM...
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...
, meeting REMS, FDA, and manufacturer program requirements Provide high-touch patient support, addressing non-clinical...
medication REMS program requirements, cold chain distribution and storage and medication delivery systems and management. Capable...
(including DSURs, PADERs and PBRERs) Contributes to the writing and/or review of the RMP/REMS documents and their maintenance...
effectiveness and safety, identify optimization and intervene as appropriate. Support quality-improvement and REMS initiatives...
, and implementing best practices for scalability. Familiarity with risk management strategies and REMS program requirements...
for infusions and authorization of Risk Evaluation and Mitigation Strategy (REMS) medications. Provide assistance and expertise...
improvement initiatives by actively participating in clinical outcome studies, REMs compliance/reporting, and ACP-related process...