Extensive experience contributing to drug applications with the FDA and EMA. Experience with applications in Japan and China...
required hand-offs. Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP...
that processes and systems are validated and maintained in accordance with applicable regulations (e.g., FDA, EMA, ISO). Review...
where needed. Proven analytical abilities as demonstrated through past experience and/or academic research. Knowledge of FDA and EMA...
Experience with assisting with biopsies and minor office surgeries is a plus Experience with EMA EMR system...
FDA & EMA regulations, ICH guidelines, GCP, and GMP. Experience with clinical logistics and pharmaceutical supply chain...
RShiny applications to meet regulatory standards such as FDA, EMA, and GxP guidelines. This ensures that the applications...
. Demonstrates advanced knowledge of FDA / EMA / etc. regulations, IND/NDA/BLA and other regulatory requirements, and EDC/CDM systems...
Imaging Endpoint Process Standards Guidance for Industry (2018), Part 11, EMA Guideline on computerized systems and electronic... Trial Imaging Endpoint Process Standards Guidance for Industry (2018), Part 11, EMA Guideline on computerized systems...
ensuring compliance with FDA, ISO, EMA and any other applicable domestic and international regulation. 6. Schedule, plan...