compliance, ensuring systems operate reliably and remain in a validated state in accordance with EMA and GxP requirements.... Roles & Responsibilities: Validate software used in laboratory and manufacturing instruments in compliance with FDA, EMA...
or Cardiology. Bilingual a plus. We use ModMed EMA for our EMR and PMS. We offer a great hours with a 4.5 day work week... in medical administrative support and patient care - Skilled in scribing, assisting, and using EMA EHR systems - Experience...
compliance with FDA, EMA, MHRA, and ICH requirements, and drives a culture of quality across the company. The VP of QA... with interactions and audits conducted by FDA, EMA, MHRA, and other global authorities in the QA capacity. Must have led...
guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations...
experience is always a plus. Our medical assistants are responsible for rooming patients, entering patient information in 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...
to detail and strong organizational skills in a fast-paced, high-volume environment. Proficiency with ModMed/EMA EMR and PMS...
) and participate in FDA/EMA and other agency interactions Partner with Biostatistics, Clinical Pharmacology, and Translational Science... authority interactions (e.g., FDA Type B/C meetings, EMA Scientific Advice) and contribution to major submissions Technical...
during EOC activation of operational periods established at the discretion of the EMA Director or Designee. Proficiency...