. Have experience with submissions including human factors data outside the US, such as EMA, MHRA, PMDA, NMPA, etc. Have experience...
as a Medical Assistant in an outpatient clinical setting Comfort using EMR/EHR systems (ModMed/EMA a plus) Preferred...
) in compliance with FDA, EMA, ICH guidelines, and other regulatory requirements. Ensure all processes and products comply... and/or regulatory inspections. Excellent communication skills. Knowledge of FDA, EMA, ICH guidelines, and cGMP regulations...
, EMA, HIPAA, 21 CFR Part 11) Help prepare training materials, documentation, and change management assets tailored...
, but not limited to: AWS CWI, API 510, 570, SI, (Source Inspector), Electrical Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting...
autonomy, EMA EMR, optional cosmetics/surgery. Up to 6 weeks PTO + 2 weeks CME. Join a premier Dermatology group with 50... facilities powered by EMA EMR and a strong clinical infrastructure that lets you focus on patient care, not paperwork...
The is seeking a Product Specialist to join the team. In compliance with FDA and EMA regulations, completes...
, but not limited to: AWS CWI, API 510, 570, SI, (Source Inspector), Electrical Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting...
experience or other relevant experience within the Pharmaceutical industry/FDA/EMA. Proven track record of successful management...
drafts for patent filings, IND (US-FDA) or CTA (EMA) filings is desirable. Subject to the terms of their respective plans...