documents and regulatory responses Experience in leading writing activities for major US and/or EMA regulatory submissions...
and executing validation strategies, protocols, and test scripts for computerized systems while ensuring compliance with FDA, EMA... including IQ, OQ, PQ, UAT, and system qualification. Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and Data...
, and flexibility you need to focus on exceptional patient care. State-of-the-art facilities with fully integrated EMR (EMA...
Strong understanding of clinical trial design and regulatory frameworks (ICH-GCP, FDA, EMA) Fluent English required;Spanish...
Strong understanding of clinical trial design and regulatory frameworks (ICH-GCP, FDA, EMA) Fluent English required;Spanish...
Strong understanding of clinical trial design and regulatory frameworks (ICH-GCP, FDA, EMA) Fluent English required;Spanish...
Medical Device Regulation, EU In-vitro Device Regulation, EMA Policies 0043 & 0070, & PhRMA/EFPIA Principles for Responsible...
and Regulatory Agency requirements (e.g., FDA, EMA, MHRA, etc..) for the Rensselaer site. Conduct investigations of OOS, Deviations...
of pharmacology, pharmacokinetics, and biochemistry/enzymology;familiarity with PK related FDA/EMA regulatory guidance...
with fully integrated EMR (EMA) Experienced administrative and clinical support staff Strong clinical and operational support...