Manager, Clinical Insights and Alliances Incubation
, EMA). Project Management Professional (PMP) certification with proven success with external partnerships...
, EMA). Project Management Professional (PMP) certification with proven success with external partnerships...
, EMA). Project Management Professional (PMP) certification with proven success with external partnerships...
with: interacting with Health Authorities, including FDA or EMA (European Medicines Agency), during inspections; working with Regulatory...
and policies specific to pharmaceutical manufacturing, distribution, and sales In-depth knowledge of FDA regulations, EMA...
and policies specific to pharmaceutical manufacturing, distribution, and sales In-depth knowledge of FDA regulations, EMA...
industry methods with minimal guidance and supervision. Knowledgeable of current FDA and EMA GLP compliance as it relates...
with relevant regulations and guidance (e.g., ICH, FDA, EMA, etc.) Conduct Regulatory Intelligence related to the assigned programs...
experience and/or academic research. Has in-depth knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity...
modalities and biologics. Direct experience with GLP-regulated studies, GLPs and knowledge of FDA/ICH/EMA guidance governing...
and interprets these. Knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national...