Medicines Agency (EMA). Key Responsibilities: · Responsible and accountable for one or more clinical studies. · Leverages...
to senior leadership Ensure compliance with GxP, FDA, EMA digital regulations A good match: 8+ years of experience...
, regulatory correspondence). Represent clients at FDA, EMA, and international regulatory meetings as senior medical authority... development pathways for sponsors. Represent the firm in FDA, EMA, and other agency meetings, serving as a credible...
guidelines (FDA, EMA, ICH), Good Clinical Practice (GCP), and global health authority requirements for clinical trials...
Comfortable handling difficult patient conversations with professionalism Technologically proficient (ModMed/EMA EMR, Klara...
compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines. Executes procedures...
agreements Familiarity with GCP, ICH, and relevant FDA/EMA guidelines from a financial perspective Demonstrated ability...
internal and external stakeholders Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines...
, and Training solutions in alignment with regulatory expectations (e.g., FDA, EMA) and company SOPs Hands-on experience...
. Uploading of closed clinic notes from EMA to Athena by the end of clinic or within 24 hours of the visit if the physician... has had to delay closing the note. Alerting the physician that notes need closing in EMA if not done by the day after the...