Medical Affairs (Life Sciences) work includes:
•Planning, and executing clinical trials/research and data collectionactivities
•Contributing to implementation of clinical protocols and facilitatingcompletion of final reports
Recruiting clinical investigators and negotiating study design and costs
•Directing human clinical trials, phases III and IV, for companyproducts under development
•Participating in adverse event reporting and safety responsibilitiesmonitoring
•Coordinating and providing reporting information for reports submittedto regulatory agencies
•Monitoring adherence to protocols and determining study completion
•Coordinating and overseeing investigator initiations and group studies
•Serving as medical consultant to marketing, commercial or researchproject teams and government regulatory agencies
•Signing off on product safety reviews
In some organizations, may participate in adverse event reporting andsafety responsibilities monitoring. May act as consultant/liaison withother corporations when working under licensing agreements.