Process Engineer III, NPI - Site MSAT - Site Based, Seattle, WA
manufacturing technologies Knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance...
manufacturing technologies Knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance...
a MUST Ability to multitask in a fast-paced environment Experience in a medical office preferred EMA/EMR experience preferred...
: Understanding of cGMP and Quality systems;familiarity with FDA/EMA guidance relevant to gene and cell therapy;experience...
with global regulations (FDA, EMA, ICH, and other standards). The ideal candidate will bring strong GMP expertise and hands...
attitude a MUST Ability to multitask in a fast-paced environment Experience in a medical office preferred EMA/EMR experience...
). Maintain accurate and up-to-date patient charts, demographic, and insurance information in EMA. Maintain a clean, organized... information into EMA. Update and maintain the PA log, ensuring accuracy of codes and documentation. Financial & Payment...
. Ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GxP, ISO). Conduct regular...
that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators...
that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators...
of pharma regulatory and compliance frameworks (e.g., Medical, Legal and Regulatory reviews, FDA/EMA guidelines). Proven...