, such as FDA, EMA, MHRA, PIC/S, ICH, and sterility assurance standards. Experience working with third-party manufacturers...
authorities is strongly preferred (FDA, EMA etc.) Exceptional interpersonal and communication skills, with the ability to build...
, FDA/EMA and other applicable global health authority regulations, Good Pharmacovigilance Practices (GVP), and Ultragenyx...
and manage client engagements focused on IT compliance, including but not limited to FDA, EU EMA, and other global health... EMA regulations, as applicable to automated business processes Data Integrity including ALCOA+ Experience...
alignment on CQV activities and project timelines. Ensure compliance with regulatory requirements (FDA, EMA...
protocols (e.g., OPC UA, OPC DA, CFX, CAMX, OIB, SECS/GEM) Familiarity with GxP, FDA/EMA compliance concepts (e.g., FDA 21 CFR...
information systems compliance including but not limited to 21 CFR Part 11 and EMA guideline on computerized systems used...
Modernizing Medicine / EMA Electronic Medical Record (EMR) highly preferred. Compensation The position will offer competitive...
and a strong administrative team that keeps your day running smoothly. Modern, tech-enabled workflow using EMA / EMR Efficient scheduling...
will be part-time, 2 days per week. Our practice maintains a patient-centered and provider-centric approach, through EMA electronic...