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Senior Manager Clinical Evaluation Strategy

Smith & Nephew

This is a Full-time position in Pittsburgh, PA posted March 30, 2021.

nnWorks closely with cross functional groups (Evidence Evaluation, Marketing, Regulatory, R&D, Global Clinical Strategy) to develop post market evidence generation strategies that consider global evidence for regulatory approvals and commercial claims and indications.Supervises teams of SMEs (Clinical Evaluation Strategy team) to develop and deliver on project assignments, creation and evaluation of PMCF plans, clinical data gap analyses, and professional development plansWork with NPD and marketing teams to establish user needs, claims, indications and market strategies, and develop the evidence strategies to meet those needs. Manages large scale programmes of clinical evidence activities such delivery of EU MDR documentation and clinical data gap analysis & sufficiency assessmentsInterprets internal and external business issues and regulatory requirements, and drives best practice 5% EducationBachelors in a relevant discipline as a minimum.

Masters degree or PhD preferred.Experience3-5 years of management experience5-7 years’ experience (commercial)Strong understanding of evolving post market clinical evidence requirements (EU MDR).Experience working within a medical devices or pharmaceutical organisation in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.

Experience in the Orthopaedics field would be beneficial.Experience in developing strategies to generate clinical evidence is requirednn