safety processes for clinical trials Knowledge of GCP, FDA, MHRA and EMA regulatory requirements for clinical trial...
and applicable FDA/EMA Guidance;Collaborate with manufacturing, engineering, facilities, and quality assurance to Responsible...
% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial...
and Enrollment, Compliance, and Payor Contracting. EMR: EMA by Modernizing Medicine Marketing support to promote your online...
: EMA by Modernizing Medicine Marketing support to promote your online presence includes organic search, online lists...
., original/supplemental approvals, expedited program designations), and health authority engagements (e.g., FDA, EMA...
all regulatory documents meet regulatory requirements and guidelines (e.g., FDA, EMA) and company standards Stay...
regulations, including to the FDA, EMA, MHRA, and all assigned international RAs Implement pharmacovigilance SOPs and ensure the..., and other countries' Regulatory reviews;experience in US, EU Canada, Brazil, Australia preferred Direct FDA and EMA...
statisticians. Has led phase 1 and phase 2 oncology studies. Knowledgeable regarding FDA/EMA/ICH guidelines for drug development...
studies. Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical...