Senior Clinical Research Director
: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health...
: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health...
, and regulatory readiness. cGMP & Regulatory Compliance: Understanding of FDA (CFR)/EMA regulations (USP, Annex 1), FDA Guidance... & Regulatory Compliance: Understanding of FDA 21 CFR Parts 210, 211, 600, and 640, EMA Guidance for Plasma-Derived Medicinal...
suite used in daily work, including Microsoft Office (Excel, Word, Outlook), ModMed/EMA, Zoom, and Klara, to collaborate...) skills. Experience with the EHR/PM system Modernizing Medicine/EMA is a plus. Knowledge of California specific payer...
Experienced support staff, including dedicated medical assistants providing scribing support User-friendly EMA electronic medical...
medical history, and confirm their purpose of visit. Efficiently enter patient information into our state-of-the-art EHR (EMA...
any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock...
. Knowledge of ICD-10 and CPT coding Familiarity with the ModMed EMA EMR is strongly preferred. Thorough understanding of HIPAA...
authorities (e.g., FDA, EMA, PMDA) for assigned gene therapy projects, leading and facilitating interactions, teleconferences... with global regulatory submissions (e.g., IND/CTA, BLA/MAA) and interactions with major health authorities (FDA, EMA...
in interactions with global Health Authorities (FDA, EMA, MHRA, RoW agencies) and contributing to the advancement of our oncology... with global regulatory bodies (FDA, EMA, MHRA), aligning statistical strategies with current guidelines (including Project Optimus...
to management and correct where possible. Adhere to current Good Manufacturing Practices (cGMP), FDA, EMA, USP...