, NDA/sNDA and EMA) and end to end programming experience. Knowledge and experience working with CDISC Standards...
and competitive data is accurate, scientifically sound and credible. Stay current with FDA and EMA regulations and guidance...
of all interactions with patients via EMA. 5. Speaks with patients or patient representatives to give biopsy and lab results. 6. Obtains...
Expertise in Spotfire or other data analysis tools Knowledge of GCP, EMA, and FDA policies Expertise in authoring clinical...
for each member. Assess and evaluate member’s initial needs through the EMA screening tool. Educate members about Case Management... quality standards are met. Abide by NASW code of ethics, HIPPA and Atlanta EMA Case Management Standards to ensure a high...
application of FDA GMP and EMA regulations. Competency in MS Word, MS Excel, MS Power Point, MS SharePoint and MS Project Plant...
metadata using EMA Avails - Demonstrated ability to work cross-functionally with engineering, design, and marketing/business...
authorities (e.g., FDA, EMA, and other global regulatory agencies) Independently or with limited oversight, plan, compile, review... with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission Coordinate with vendors to appropriately plan...
with internal requirements, regulatory requirements, including FDA, EMA, and ISO standards. Create and maintain standards guides... oriented, self-starter with experience in a complex manufacturing environment. Experience with FDA, EMA, and ISO regulations...
guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard...