. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA...
, EMA, or other worldwide regulatory agencies Develop software systems to generate displays of clinical study data... programming team leader or manager Fluency in English and Chinese Strong knowledge of relevant regulatory (FDA, NMPA, EMA, PMDA...
of cleaning processes. Ensure compliance with regulatory guidelines (FDA, EMA, cGMP, ICH) and internal SOPs. Participate... maintenance, and responding to compliance requirements. Strong knowledge of cGMP, FDA, EMA, and ICH cleaning validation...
regulatory requirements, including FDA, EMA, and ICH guidelines. Act as the primary liaison between clients, internal teams...
, testing and offer creation. · Maintain, edit, and/or add default pricing by contract in CVM. · Manually create EMA format...
standards, taxonomies, and controlled vocabularies with global regulatory requirements (e.g., ICH, EMA, FDA)​ Lead governance...
from electronic data capturing system and cleaning data;and (h) working with regulatory guidelines including GCP/ICH, FDA/EMA/CHMP...
, GMP+, SQF, and familiarity with FDA/EMA expectations. Practical experience in implementing and maintaining site-level...
. Facilitate the deployment and management of the OSHA PSM, EMA RMP, and GSK 5.13 programs. Develop personal Process Safety...
% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial...