Conformance Specialist - Berkeley, CA
and regulatory requirements (FDA, EMA, ICH, etc.);Experience in performing investigative work;Knowledge and hands-on experience...
and regulatory requirements (FDA, EMA, ICH, etc.);Experience in performing investigative work;Knowledge and hands-on experience...
(FDA, EMA, ICH, etc.) guidelines in a biological or pharmaceutical manufacturing environment. · Experience interacting...
medical history, and confirm their purpose of visit. Efficiently enter patient information into our state-of-the-art EHR (EMA...
and supporting regulatory inspections is a plus (FDA, MHRA and EMA);Strong communication skills;Strong quality mindset...
or name and address into EMA. Collecting all pertinent information at check in. (NPP, INS & ID, Demos, CCOF) Updating the... and EMA software and Lightspeed Ability to stay focused on tasks to be accomplished while working in dynamic situations...
range of regulatory inspections (FDA, EMA, MHRA) and facilitating QA relationship with external clients. The position... preparation;Reviewing, and analyzing regulatory inspection data issued by regulatory authorities (e.g. MHRA, EMA, FDA);Manage...
service standards Knowledge of ICD-10 and CPT coding (preferred) Familiarity with the ModMed EMA EMR (preferred) Thorough...
maintenance plans. Ensure compliance with cGMP, FDA/EMA regulations, internal quality systems, and safety standards. Support...
, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock), Tandem, CoverMyMeds, LabCorp (software for looking up labs...
, or related degree is preferred. Familiarity with ModMed, EMA, EMR preferred. Thorough understanding of HIPAA laws...