Thermo Fisher Scientific
Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
10,000+
Medical Director - Cardiology
September 20
Thermo Fisher Scientific
Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
10,000+
Description
• Provide medical support and medical advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department • Provide medical leadership to the study teams, including creating clinical trial protocols • Contribute to site selection, review and approval of study protocols and amendments • Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint and study subject safety • Educate Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting • Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
Requirements
• Education MD, MB/BS or equivalent degree and strong medical knowledge, shown clinical experience running Cardiology patients in hospital practice • Board certified in Cardiology • Experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important • Is fluent in spoken and written English • Shown understanding and experience with NDA submission process • Shown understanding of regulatory guidelines for adverse event reporting • Strong communication & presentation skills and is a strong teammate
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