. Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations...
and application of global regulatory guidance (e.g., FDA, EMA, PMDA, etc.) that are essential in designing drug development strategy...
are not an exhaustive list; EMA would be happy to discuss a customized position based on your background and interests and the needs of the...
literature, published studies, and regulatory guidances (e.g., FDA, ICH, EMA) Analyze and provide recommendations on concomitant..., ICH, EMA) Analyses of clinical trial PK and/or PK/PD data in NONMEM, R and/or related software Participate in the design...
. Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations...
with the Ophthalmic Retina Community and regulatory authorities in US, EU and APAC Integrated understanding of FDA, EMA..., ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies is desirable. Base salary compensation...