Investigator I / II
, biotechnology, chemical, industrial, or other highly regulated operations Knowledge of cGMP, cGLP, OSHA, EMA, FDA, or similar...
, biotechnology, chemical, industrial, or other highly regulated operations Knowledge of cGMP, cGLP, OSHA, EMA, FDA, or similar...
. Knowledge of Athena, Epic, EMA EMR systems a plus. Must have a valid driver's license and be willing and able to drive...
or managing direct reports is desirable. Experience in writing technical drafts for patent filings, IND (US-FDA) or CTA (EMA...
of FDA, EMA, and ICH guidance relevant to clinical pharmacology (e.g., ICH M12 on drug interaction studies, ICH M15 on MIDD...
audits (FDA, EMA, Anvisa, etc) and internal audits. Manage and oversee the interrelated function activities including design...
to join an established practice in Nashville. Our practice maintains a patient-centered and provider-centric approach, through EMA electronic...
. Our practice maintains a patient-centered and physician-centric approach, through EMA electronic medical records, stellar customer...
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...
required skills. Determines eligibility for Spanish and English speaking patients for Medicaid, EMA and financial assistance programs...
areas organized and records readily retrievable. Support internal/external audits (FDA, EMA, MHRA) by presenting chain...