and familiarity with FDA, EMA, and global regulations. Strong scientific writing skills and communication skills (written and verbal...
to have (but not required): Awareness of EMA Good Pharmacovigilance Practices (GVP) Understanding of adverse events (AE) and/or AE reporting Experience...
and final drug product samples. We ensure adherence to Good Manufacturing Practices (GMP) and regulatory guidelines (FDA, EMA...
and final drug product samples. We ensure adherence to Good Manufacturing Practices (GMP) and regulatory guidelines (FDA, EMA...
procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations Extensive understanding of related...
analysis of an FDA or EMA-approved gene therapy, and exploration of advanced statistical techniques relevant to rare disease... FDA or EMA, including trial design, statistical strategy, and regulatory feedback. Explore one or more advanced...
. Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations...
. Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations...
in clinical trial compliance Interest in learning about audits and regulatory authority inspections (e.g. FDA, EMA...
and familiarity with FDA, EMA, and global regulations. Strong scientific writing skills and communication skills (written and verbal...