and will focus on ensuring site readiness for internal and partner audits, as well as health authority inspections (FDA, EMA, PMDA...
recommended by FDA, EMA, CLSI to conduct development, qualification and validation of assays (e.g. M10 Bioanalytical Method...
Device industry Radiopharmaceutical experience a plus Proficiency and knowledge of cGMPs, FDA, EMA, and ICH regulatory...
& Qualifications 1-2 years of recent medical office experience or in a similar capacity is required Experience with EMA and NextGen...
requirements and technical systems. In-depth knowledge of pharmacovigilance regulations and guidelines, including FDA and EMA...
universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10...
Experience with assisting with biopsies and minor office surgeries is a plus Experience with EMA EMR system...
, including FDA and EMA guidelines. · Excellent problem-solving and analytical skills, with the ability to troubleshoot...
with EMA or NextGEN DUTIES: The Medical Assistant will be responsible for, but not limited to the following: Triage...
of experience. Prior working experience in a regulated industry, for example FDA, EMA (EU GMP), Animal Health, Pharmaceutical...