Senior Biostatistician - Clinical Trials
from the FDA, EMA, and other agencies Collaborate with Data Management and Regulatory Affairs on CRF design, data validation...
from the FDA, EMA, and other agencies Collaborate with Data Management and Regulatory Affairs on CRF design, data validation...
and in compliance with all applicable federal, state, and company regulations (OSHA, EPA, FDA, EMA etc.). Responsible for the...
, EMA, and other regulatory requirements. Leadership Skills: Strong leadership and people management skills, with the...
regulations and guidance. ·Knowledge and proven experience in FDA, EMA, or other regulatory authority. ·Well-practiced...
with the EMA review process concluded positively in September 2023. It is an exciting time in the company’s development...
and influence including explaining complex quantitative issues in simple terms Solid understanding of Regulatory (FDA/EMA...
while still meeting set deadlines Good knowledge of existing guidelines dealing with cleaning and disinfection/CIP COP (EMA;FDA...
Parts 210/211, ICH guidelines, EMA requirements). Exceptional organizational, communication, and stakeholder management...
regulations (21 CFR Part 312), EMA Compassionate Use frameworks, and international regulatory requirements. Demonstrated vendor...
capabilities. As part of a small, operational EMA team, the successful candidate will also support EOC activations, exercises...