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...
, 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...
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...
% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role...
service standards Knowledge of ICD-10 and CPT coding (preferred) Familiarity with the ModMed EMA EMR (preferred) Thorough...
implementation Knowledge of regulatory compliance frameworks (GxP, FDA, EMA). Familiarity with integration tools (e.g., MuleSoft...
. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA...
for the transmission system in Eastern Massachusetts (EMA). Essential Functions: Manages the work activities of personnel... assigned to the EMA Protection & Controls Engineering section. Ensures projects undertaken are in accordance with Transmission...
experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts...
, and compliance with EMA, FDA, OSHA, and other relevant regulations. Strong vendor management skills, including contract...