GRA CMC Specialist
and risk mitigation strategies. Monitor, interpret, and communicate evolving global CMC regulations (FDA, EMA, PMDA, NMPA...
and risk mitigation strategies. Monitor, interpret, and communicate evolving global CMC regulations (FDA, EMA, PMDA, NMPA...
Readiness Oversee assay qualification, validation, transfer, and lifecycle management aligned with FDA, EMA, ICH, and WHO...
. Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA) Be responsible for interpreting analysis...
meet global regulatory requirements (FDA, EMA) and CSL Quality standards. ▪ Oversee commissioning, qualification...
, EMA qualification opinions, ISPOR standards, and cross-cultural instrument adaptation requirements. Experience...
(EMA) system (Ohio State specific data analysis tool) , CRM Salesforce), Student Information System (Peoplesoft...
and risk mitigation strategies. Monitor, interpret, and communicate evolving global CMC regulations (FDA, EMA, PMDA, NMPA...
. Awareness of regulatory guidelines in FDA and EMA guidance documents, CFR, ICH, USP, and Ph. Eur. Proficient in risk...
values Advanced systems including Modernizing Medicine’s EMA for efficient EMR and practice management Flexible...
with stakeholders to develop risk-based, compliant solutions that ensure compliance with EMA Guidelines on Good Pharmacovigilance... Regulation (EU) No 520/2012 EMA GVP Modules (I-XVI + product/population-specific modules) Organizational Agility: Strong...