) Experience supporting EMR environments and clinical workflows (ModMed EMA/PM exposure a plus) Security certifications: CISSP...
per day), onsite pathology lab and EMA / EMR Competitive compensation package with guarantee plus percentage-based incentives...
and experienced support staff already in place Efficient workflows utilizing EMA and a streamlined, team-oriented clinical model...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites... Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
with cGMP and global regulatory standards including FDA, EMA, WHO, and ICH Drive continuous improvement initiatives using Lean... Green Belt or Black Belt certification Experience supporting USFDA, MHRA, and EMA inspections Knowledge of data...
global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc. Lead analysis to identify and address changes...
for a pharmaceutical organization. Ensure compliance with industry regulations (FDA, EMA, GMP), drive process standardization, and enable...
& Validation Documentation Ensure all CQV documentation complies with GMP, FDA, EMA, and ICH requirements Author and review... management systems (BMS) Experience supporting regulatory inspections (FDA, EMA) Experience on greenfield or large capital...
, FDA and EMA regulatory requirements Experience with Electronic Document Management Systems (EDMS) (e.g., Master Control... #PharmaJobs #QualityAssurance #GMP #cGMP #BatchRecordReview #BPR #PharmaceuticalManufacturing #FDACompliance #EMA...
, FDA, EMA, etc. Leading gap analysis to ensure alignment with changes in global regulations Strategizing and drafting...