with cGMP and global regulatory standards including FDA, EMA, WHO, and ICH Drive continuous improvement initiatives using Lean... Green Belt or Black Belt certification Experience supporting USFDA, MHRA, and EMA inspections Knowledge of data...
with global health authorities, including the FDA and EMA. You will be accountable for the oversight, preparation, and submission...
patient history, visit reason, medications, and patient understanding of procedures, and make notes in EMA. Ensuring MIPS...) EClinicalWorks, EMA, or other EMR software Exciting Perks: 40% off products and procedures, as well as the ability to participate...
. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA...
regulatory agencies (FDA, EMA, Health Canada, etc.) and the biotech industry, including but not limited to 21 CFR, GxP, HIPAA...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies...
of GMP quality systems in accordance with ICH, FDA, EMA, and other global regulatory requirements Provide quality oversight...
). This position requires hands-on regulatory writing expertise aligned with ICH, FDA, and EMA expectations, strong cross-functional...: Ensure compliance with ICH guidelines, FDA/EMA guidance, company SOPs, and style conventions Contribute to template...
to have (but not required): Awareness of EMA Good Pharmacovigilance Practices (GVP) Understanding of adverse events (AE) and/or AE reporting Experience...