(e.g., US FDA, EMA, MHRA, PMDA), including drafting inspection responses, preparing submission-related GMP evidence... for organizations facing FDA Warning Letters or Consent Decrees preferred. Background working with agencies such as the US FDA, EMA...
compliance with standards with timely regulatory submissions (FDA pre-IND, IND, EMA CTA). Hands on medical monitoring duties...
inspections is a plus (FDA, MHRA and EMA);Strong communication skills;Strong quality mindset;Excellent written and verbal...
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
regulatory (FDA, EMA, etc.) guidelines in a biological or pharmaceutical manufacturing environment. Experience with regulatory...
any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock...
range of regulatory inspections (FDA, EMA, MHRA) and facilitating QA relationship with external clients. The position... preparation;Reviewing, and analyzing regulatory inspection data issued by regulatory authorities (e.g. MHRA, EMA, FDA);Manage...
medical history, and confirm their purpose of visit. Efficiently enter patient information into our state-of-the-art EHR (EMA...
regulatory (FDA, EMA, etc.) guidelines in a biological or pharmaceutical manufacturing environment. Specific Experience as the...
, or related degree is preferred. Familiarity with ModMed, EMA, EMR preferred. Thorough understanding of HIPAA laws...