of domestic and international regulations and guidance documents, with a focus on FDA & EMA regulations Broad pharmaceutical...
Assurance, Quality Systems, regulatory expectations (FDA, EMA, ICH), and end to end product lifecycle. Ability to design...
and studies Understanding of FDA, EMA, MHRA and ICH GCP guidelines as they pertain to translational strategy. At AstraZeneca...
, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases. Support exploration of new signal...
(MAA), clinical study reports (CSRs), and global regulatory submissions to the FDA, EMA, and other international health... amendments Clinical summaries and overviews FDA and EMA briefing documents Responses to Health Authority questions Advisory...
, EMA, and other global agencies. Experience with integrated analysis activities for FDA and rest of world submissions...
of previous experience in dermatology medical office preferred Experience utilizing Modernizing Medicine / EMA Electronic Medical...
: Medical Terminology. (Dermatology preferred) EMR knowledge (Helpful if familiar with EMA/ModMed) 1 years working...
, but not required. Experience using Modernizing Medicine/EMA Electronic Medical Record (EMR) is preferred, but not required. About Advanced...
to multitask in a fast-paced environment Experience in a medical office preferred EMA/EMR experience preferred...