with multiple agencies (FDA, EMA, JNDA, TGA). Leadership: Support Cell Culture CMC teams, and align resources to deliver...
, SI, (Source Inspector), Electrical Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced...
pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules...
to corporate or enterprise-level quality teams. Ensure compliance with GMP, GLP, FDA, EMA, and other applicable regulatory...
pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules...
(Excel, Word, Outlook) and revenue cycle technology platforms. Utilize EHR/PM systems (e.g., Modernizing Medicine/EMA... or in an enterprise/shared-services model. Experience with Modernizing Medicine/EMA. Knowledge of California-specific payer requirements...
and formatting content and creating job aids Knowledge of US and EU cGMP regulations and guidance (FDA, EMA, or other authorities...
environment. Understands basic FDA & EMA regulations, ICH guidelines, GCP, and GMP. Experience with clinical logistics...
(preferred) Familiarity with the ModMed EMA EMR (preferred) Thorough understanding of HIPAA law Team player Physical...
regulatory agencies (FDA, EMA, PMDA) on clinical pharmacology, translational modeling, and MIDD strategies. Coordinate... with the FDA, EMA, or other global agencies. In-depth understanding of ICH guidelines, FDA guidance on MIDD, and evolving...