with 2+ years of QA Shop Floor experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy...
the EM program as a Subject Matter Expert during internal and external regulatory inspections (FDA, EMA, etc.). Advanced... processing. Deep understanding of global regulatory requirements (FDA, EMA, ICH) for environmental and utility monitoring...
more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START...
with next day work. Answer off-hours phone calls from all UGI customers. Answer calls from 911/EMA centers and public utilities..., ARCOS Strong PC skills including all forms of Microsoft Office Understanding of UGI distribution system, local EMA/911...
with the ModMed EMA EMR (preferred) Thorough understanding of HIPAA law Team player Physical Demands Standing...
service standards Knowledge of ICD-10 and CPT coding (preferred) Familiarity with the ModMed EMA EMR (preferred) Thorough...
: Understanding of cGMP and Quality systems;familiarity with FDA/EMA guidance relevant to gene and cell therapy;experience...
of all procedures, using EMA, eClinical Works (or current practice management system) practice management system, according to policy...
Selection, and Approvals and Continuous Improvement. Provides support and interfaces directly/indirectly with the FDA, EMA, MHRA...
familiarity with GCP, regulatory requirements (FDA, EMA), ethical guidelines for biospecimen use (e.g., informed consent, GDPR...