Data Coordinator
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
regulatory agencies (FDA, EMA, PMDA) on clinical pharmacology, translational modeling, and MIDD strategies. Coordinate... with the FDA, EMA, or other global agencies. In-depth understanding of ICH guidelines, FDA guidance on MIDD, and evolving...
, and best practices GMP Compliance & Validation Ensure automation systems comply with FDA, EMA, and global regulatory requirements...
Clinical Practice (GCP), ICH E6 guidelines, applicable regulatory requirements (e.g., 21 CFR Parts 312 and 314, EMA Clinical...
environment. Understands basic FDA & EMA regulations, ICH guidelines, GCP, and GMP. Experience with clinical logistics...
authority interactions, and/or authoring clinical regulatory documents in compliance with ICH, FDA, and EMA guidelines...
Ability to post copays into EMA Ability to verify straight Medicare vs Medicare Advantage Plan Distinguish primary insurance... Proficiency in Microsoft Office and EMA software Effective verbal and written communication skillsAbility to maintain...
(Excel, Word, Outlook) and revenue cycle technology platforms. Utilize EHR/PM systems (e.g., Modernizing Medicine/EMA... or in an enterprise/shared-services model. Experience with Modernizing Medicine/EMA. Knowledge of California-specific payer requirements...
pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules...
(preferred) Familiarity with the ModMed EMA EMR (preferred) Thorough understanding of HIPAA law Team player Physical...