Associate Director, Biostats
with drug development in biologics, targeted therapies, and companion diagnostics preferred Experience working with FDA, EMA...
with drug development in biologics, targeted therapies, and companion diagnostics preferred Experience working with FDA, EMA...
, drug stability according to ICH, FDA, and EMA standards, and biophysical characterization. - Prepare and maintain accurate...
Records (EMR) Proficiency with NextGen and EMA Basic medical knowledge Patient care experience Additional Skills... scheduling experience is a plus. Experience with NextGen, EMA, or Phreesia is a plus. Ambulatory surgical scheduling experience...
with EMR systems, specifically NextGen and EMA. Additional Skills & Qualifications Medical Assistant certification 1-2...
and documentation. Stay current on global regulatory requirements (FDA, EMA, ICH, GCP). May participate in or lead quality improvement...
, etc.) Basic understanding of cGMP principles and regulatory requirements (FDA, EMA, ICH). Familiarity with quality management...
, EMA, notified bodies) Proficiency with Veeva Vault, MasterControl, or similar EDMS platforms Resourceful Detail...
, or process validation documentation Experience in regulated environments with high-visibility audits (FDA, EMA, notified bodies...
regulations and guidance (FDA, EMA, NMPA) for Phase II & III. Respond to authority queries and support deficiency resolution...
regulatory standards, including FDA (21 CFR), EMA, MHRA, WHO GDP, and local health authorities, by aligning distribution...