Practice Manager
. Knowledge of Athena, Epic, EMA EMR systems a plus. Must have a valid driver's license and be willing and able to drive...
. Knowledge of Athena, Epic, EMA EMR systems a plus. Must have a valid driver's license and be willing and able to drive...
, biotechnology, chemical, industrial, or other highly regulated operations Knowledge of cGMP, cGLP, OSHA, EMA, FDA, or similar...
audits (FDA, EMA, Anvisa, etc) and internal audits. Manage and oversee the interrelated function activities including design...
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...