Director, Manufacturing
of cGMPs and regulatory guidance requirements (FDA, EMA, PIC/S, etc.). Previous leadership of commercial GMP manufacturing...
of cGMPs and regulatory guidance requirements (FDA, EMA, PIC/S, etc.). Previous leadership of commercial GMP manufacturing...
claim rejections Ability to post copays into EMA Ability to verify straight Medicare vs Medicare Advantage Plan...
of completing all patient Demographics to avoid claim rejections Ability to post copays into EMA Ability to verify straight...
of cGMP, ICH, FDA, EMA regulations or guidelines Intermediate understanding of pharmaceutical laboratory and/or production...
exposure to FDA / EMA / PMDA / ANVISA or other authorities of similar standing. Experience working with investigational...
agency expectations (FDA, EMA, ICH, etc.). Strong knowledge of regulatory submission systems (eg, Veeva Vault QMS, eCTD, CTD...
, and climate policy. BA/BS required. Preferred: Energy efficiency training (IEMA, EMA, Certified Energy Manager (CEM...
Protocol development experience Understanding of regulatory requirements related to clinical trials e.g. FDA, EMA, MHRA...
of completing all patient Demographics to avoid claim rejections Ability to post copays into EMA Ability to verify straight...
required. Extensive working knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and have a proven...