Lead Cost Manager, Infrastructure & Capital Projects
Accenture
Senior Manager, Clinical Science, Medical Affairs
Edwards Lifesciences
full-time
Posted on:
Location Type: Hybrid
Location: Irvine • California, Illinois, Texas, Washington • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Provide scientific expertise for clinical studies and evaluations in the TMTT division
- Independently author complex documents including clinical protocols and reports
- Conduct literature reviews from initiation to completion
- Review raw and summary clinical data for accuracy
- Analyze safety and effectiveness results from clinical trials
- Collaborate with cross-functional teams on study results
Requirements
- Bachelor's Degree in a related field with 10 years of related experience in clinical science or medical/scientific writing; OR Master's degree with 8 years of related experience; OR Doctorate degree with 8 years of related experience
- Familiarity with coronary interventional and/or structural heart environments
- Experience in the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations
- Experience with FDA PMA applications
- Strong knowledge of scientific research methodology, GCP, ICH guidelines and Global regulations
- Experience in a cross-functional environment, collaborating with various specialists
- Excellent communication skills and experience influencing stakeholders
- Expert knowledge of regulatory requirements and clinical study execution
Benefits
- COVID Vaccination Requirement: proof of vaccination required for healthcare roles
- Equal Opportunity/Affirmative Action employer
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical protocolsclinical reportsliterature reviewsclinical data analysissafety and effectiveness analysisscientific research methodologyGCPICH guidelinesMEDDEV 2.7/1EU MDR
Soft skills
communication skillsinfluencing stakeholderscollaborationcross-functional teamwork
