Medical Director
with partners, investigators, contractors, consultants, and team members across functions. Knowledge of FDA/EMA requirements, good...
with partners, investigators, contractors, consultants, and team members across functions. Knowledge of FDA/EMA requirements, good...
right first-time manufacturing in accordance with FDA/EMA/ICH regulations/guidance. Lead root cause investigations...
for individual studies and ISS/ISE to FDA, EMA, and other worldwide regulatory agencies Participate in the review of statistical...
in a medical office preferred. Familiarity with ModMed/EMA system is a plus. Bilingual in Spanish/English is strongly preferred...
and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.) Excel in a quality driven...
with relevant GMP guidelines, including FDA, EMA, and other regulatory bodies. -Align local site based procedures with global SOP...
is required. Understanding of US and EMA labelling requirements for GRL role is preferred. In depth knowledge of current US FDA, Health Canada... (and EMA for GRL) and global regulations as they relate to overall regulatory strategy is preferred. Ability to work...
such as Modernizing Medicine (“EMAâ€). Ability to adhere to strict attendance and punctually expectations. Ability to attend...
Experience with assisting with biopsies and minor office surgeries is a plus Experience with EMA EMR system...
of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (FDA, EMA, Health Canada, MHRA...