of FDA, EMA, and ICH guidance relevant to clinical pharmacology (e.g., ICH M12 on drug interaction studies, ICH M15 on MIDD...
recommendations to functional and site leadership. Conduct regulatory and procedural gap assessments against applicable FDA, EMA... regulations, FDA and EMA expectations, data integrity, good documentation practices, and quality systems;knowledge of ATMP and EU...
or managing direct reports is desirable. Experience in writing technical drafts for patent filings, IND (US-FDA) or CTA (EMA...
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...