frameworks and inspection expectations (e.g., FDA, EMA, MHRA, ICH, PIC/S). Proven experience developing and maturing inspection...
a professional demeanor at all times. Some duties include reviewing medical documentation for accuracy, using EMA EMR to document...
, or related degree is preferred. Familiarity with ModMed, EMA, EMR preferred. Thorough understanding of HIPAA laws...
, EMA, or other EMR software Exciting Perks: 40% off products and procedures, as well as the ability to participate...
in this position may operate any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD...
. REQUIREMENTS: Thorough knowledge of FDA, EMA, and international GMP regulations Proven ability to review and approve GMP...
, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock), Tandem, CoverMyMeds, LabCorp (software for looking up labs...
, commercial, HMO) EClinicalWorks, EMA, or other EMR software Exciting Perks: 40% off products and procedures, as well as the...
and health authority interactions (FDA, EMA, Notified Bodies, NMPA) under direction of the Global Head of HFUE Collaborate...: all relevant FDA HF Guidance documents, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, EMA guidelines Experience designing...
, FDA, EMA, and other global regulatory requirements, including expertise in medical coding, CDISC standards (SDTM, ADaM...