audits (FDA, EMA, Anvisa, etc) and internal audits. Manage and oversee the interrelated function activities including design...
Regulations, ICH, EMA and/or other international healthcare regulations. Minimum 5 years of experience working with regulated IT...
pharmacovigilance regulations and requirements EMA regulations Applicable regulatory guidance and standards Required: Experience...
is a plus. Experience with bioanalytical method validation (e.g., per FDA or EMA guidelines). Working knowledge of statistical analysis...
required skills. Determines eligibility for Spanish and English speaking patients for Medicaid, EMA and financial assistance programs...
, including expertise in the pharmaceutical sector, familiarity with FDA/CVM, USDA/CVB, EMA, VICH Guidelines, Clinical Field...
areas organized and records readily retrievable. Support internal/external audits (FDA, EMA, MHRA) by presenting chain...
., per FDA or EMA guidelines). Working knowledge of statistical analysis tools (e.g., GraphPad Prism, JMP, or Excel-based...
.• Knowledge of Athena, Epic, EMA EMR systems a plus.• Must have a valid driver's license and be willing and able to drive...
against applicable FDA, EMA, ATMP, and EU GMP Annex 1 expectations;translate identified gaps into risk-based remediation plans. Support.... Working knowledge of cGMP regulations, FDA and EMA expectations, data integrity, good documentation practices, and quality...