& Scientific Leadership Serve as the primary medical lead in interactions with regulatory agencies (FDA, EMA, and others). Lead...
mitigation and data quality strategies. In-depth knowledge of ICH-GCP, FDA/EMA regulations, and GCDMP. Strong expertise...
, or related degree is preferred. Familiarity with ModMed, EMA, EMR preferred. Thorough understanding of HIPAA laws...
leadership, quality, and regulatory stakeholders. Compliance & Documentation Ensure schedules reflect FDA, EMA, EU Annex 15...
, commercial, HMO) EClinicalWorks, EMA, or other EMR software Exciting Perks: 40% off products and procedures, as well as the...
. Compliance & Documentation Ensure schedules reflect FDA, EMA, EU Annex 15, and ISPE requirements. Support audit readiness...
duties: Prepares Site Master Files (SMFs) required for external EMA inspections through collaboration with donor centers... inspections / audits (FDA, EMA, CLIA/COLA, PPTA, State, Health Canada, internal compliance audits). Supports donor centers...
with, regulatory agencies (FDA, EMA or equivalent). Deep familiarity with GMP compliance, clean utilities (e.g., HVAC, WFI, compressed...
., IRB. FDA submissions) for clinical research. Assist with interpretation and application of regulations (FDA, EMA...
, timelines, and resource allocation Strong understanding of global regulatory expectations and agencies such as FDA and EMA...