to have (but not required): Awareness of EMA Good Pharmacovigilance Practices (GVP) Understanding of adverse events (AE) and/or AE reporting Experience...
. Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.). Supports regulatory requests...
, and compliance requirements, including ICMJE, GPP, FDA, EMA, and internal SOPs. Maintain awareness of competitor publications... standards and compliance requirements (e.g., ICMJE, GPP, FDA, EMA). Experience collaborating cross-functionally with Clinical...
and familiarity with EMR systems (ModMed/EMA). Professional, detail-oriented, and compassionate toward patients...
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...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
interactions with regulatory authorities (eg FDA, EMA, PMDA) 5 Be responsible for interpreting analysis results and ensuring...
of working with EMA is preferred Must have strong verbal and written communication skills Scribing experience is highly...
oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.). Supports regulatory requests and inspections. Supports the QC...