regulatory interpretation of evolving FDA/EMA guidance related to obesity and related conditions (where applicable... Authority interactions (FDA, EMA, PMDA, NMPA, etc.) related to metabolic disorders, including protocol advice, CV safety...
, and integrations between systems. Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems...
to handle high-stakes regulatory content, such as EMA/FDA filings or MedDRA/EDQM terminology. Benefits If you feel you meet...
: Proven ability to handle high-stakes regulatory content, such as EMA/FDA filings or MedDRA/EDQM terminology. Benefits...
a professional demeanor at all times. Some duties include reviewing medical documentation for accuracy, using EMA EMR to document...
to handle high-stakes regulatory content, such as EMA/FDA filings or MedDRA/EDQM terminology. Benefits If you feel you meet...
: Assess and approve data flows, interfaces, and integrations between systems. Support regulatory inspections (FDA, EMA...
regulatory content, such as EMA/FDA filings or MedDRA/EDQM terminology. Benefits If you feel you meet these criteria...
in a collaborative setting Receive dedicated support from skilled medical assistants and professional administrative staff Utilize EMA...
(IND) applications and clinical trial protocols. Ensure compliance with regulatory standards (FDA, EMA, etc.) during the...