capabilities. Preferred Qualifications: Experience supporting regulatory inspections (FDA, OSHA, EMA). Knowledge of RCM, FMEA...
to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. The START...
to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. The START...
understanding related to drug development Knowledge of FDA, EMA, WHO, and ICH regulatory requirements Excellent laboratory...
, including having played a lead role in more than one IND/IMPD, BLA/NDA/MAA filing and in Advisory Committee or other PMDA/EMA... major regulatory filings - IND/IMPD, BLA/NDA/MAA. Experience leading preparation of PMDA/EMA/FDA milestone meetings...
with tech transfer, scale up, and process validation for biologics. Familiarity with global regulatory frameworks (FDA, EMA...
practical, well-reasoned solutions. Contribute to internal regulatory intelligence efforts by summarizing new FDA, EMA...
with the ModMed EMA EMR (preferred) Thorough understanding of HIPAA law Team player Physical Demands Standing...
that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators...
. Knowledge of ICD-10 and CPT coding Familiarity with the ModMed EMA EMR is strongly preferred. Thorough understanding of HIPAA...