of all interactions with patients via EMA. 5. Speaks with patients or patient representatives to give biopsy and lab results. 6. Obtains...
and resolution). Prior experience with quality in a cGMP setting. Experience working with regulated GMP systems and FDA, EMA...
documentation Knowledge of regulatory guidelines, including GCP/ICH, FDA/EMA/CHMP, 21 CFR Part 11, validation requirements...
’ experience in Pharma required including a thorough understanding of PV processes Working knowledge of FDA, EMA PV regulations...
Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA...
with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies...
safety processes for clinical trials Knowledge of GCP, FDA, MHRA and EMA regulatory requirements for clinical trial...
past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies...
with relevant regulatory guidelines (FDA, EMA). Maintain rigorous quality control standards throughout the process development...