Eric Bourne Email & Phone Number

•15 years of Clinical Development experience (Phase II through IV)oMember of cross-functional medicine development teams (Regulatory, Commercial, Safety, Clinical Operations, Data Management, Monitoring, and Biostatistics) to develop plans for differentiated and reimbursable filesoPresenting study plans and budget to senior management for approval in accordance with clinical development plansoPrimary presentations (protocol, recruitment strategy) at Investigator, Monitor Training, and Global Study Management meetingsoTherapeutic area scientist on study teams •Over 10 years of Medical writing including:oConcept protocols, full protocols, protocol amendments, clinical study reports, clinical trial summaries, study procedure manuals, monitoring plans and clinical development plansoClinical Investigator Brochures, IND Annual Reports, and part of sNDA review team (clinical)oDocument guidelines (template management) and SOPs for clinical and regulatory documentsoLeading round tables for review of clinical/regulatory documentsoWorking with document specialists and publishing groups•Over 10 years of managing Scientific Communications includingoData review and interpretation (clinical trial reporting, post hoc and integrated analyses) for external communications including peer-reviewed manuscripts, abstracts, posters, and oral presentationsoOral and poster presentations at conferencesoEstablishing confidentiality disclosure agreements and working with external authors to complete manuscripts for peer-reviewed journals oDeveloping/reviewing SOPs, communication plans and managing communication databases- ex. Datavision

Listed skills include Medical Writing, Clinical Development, Clinical Trials, Protocol, and 12 others.