years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies...
with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support...
resolution. Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry... requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations. Prepare and contribute to regulatory submissions...
service standards Knowledge of ICD-10 and CPT coding (preferred) Familiarity with the ModMed EMA EMR (preferred) Thorough...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
) Experience supporting EMR environments and clinical workflows (ModMed EMA/PM exposure a plus) Security certifications: CISSP...
). 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...
, which includes leadership in more than one IND/IMPS, BLA/NDA/MAA, Advisory Committee or other PMDA/EMA/FDA meetings is desirable... and analyze complex situations Has experience leading preparation of PMDA/EMA/FDA milestone meetings, such as Pre-IND, EoP-1...
or name and address into EMA. Collecting all pertinent information at check in. (NPP, INS & ID, Demos, CCOF) Updating the... and EMA software and Lightspeed Ability to stay focused on tasks to be accomplished while working in dynamic situations...
global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc. Lead analysis to identify and address changes...