). 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...
guidelines including regulatory initiatives/actions from ICH, FDA, EMA and other countries as appropriate. Enhances regulatory...
more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START...
—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs...
1, Ph 2 and Ph 3). Seek input from regulators through EMA | HTA joint scientific advice to inform an asset...
and major regulatory interactions, and represent Biostatistics in engagements with global regulatory authorities (e.g., FDA, EMA...) and interactions with health authorities such as FDA, EMA, and PMDA. Experience with people management, particularly in developing...