and regions (e.g., FDA, EMA, PMDA, NMPA) - CTMS data: sites, enrollment, milestones, monitoring, and operational performance...
documents, global PV regulatory environment, EMA regulations (Required) Writing experience;science/medical writing...
(e.g., FDA, EMA) Experience in gene therapy, rare disease, and/or ophthalmology clinical development Proficient...
, validation, and/or technology transfer. Experience authoring technical documents supporting regulatory filings (FDA, EMA, JNDA...
those of the FDA, EMA, and other relevant authorities. Ability to collect, process, and analyze data using established methods...
FDA, EMA, ICH, and ISO. · As a member of the Quality Leadership Team and key advisor on global compliance policies...
differences from manned aircraft. Experience with EMA or EHA control surface actuators. Secret clearance eligible...
. Knowledge of Athena, Epic, EMA EMR systems a plus. Must have a valid driver's license and be willing and able to drive...
, biotechnology, chemical, industrial, or other highly regulated operations Knowledge of cGMP, cGLP, OSHA, EMA, FDA, or similar...
audits (FDA, EMA, Anvisa, etc) and internal audits. Manage and oversee the interrelated function activities including design...