Job Description

Work Flexibility: HybridWhat you will doDriving the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle and fostering alignment with adjacent complex processes (Marketing strategy and claims, regulatory strategy, clinical research strategy, testing strategy).Designing compliant and sustainable literature search strategies, and performing complex literature queries to retrieve published clinical data,Identifying, appraising, and analyzing all relevant (clinical, PMS, marketing, and testing data) from multiple sources and formats and create a comprehensive scientific review, including in depth statistical analyses, risk management cross-check and descriptive analyses, following complex and rigorous methodologies.Analyzing the current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques.Based on a detailed and up-to-date understanding of US, European and Australian regulatory requirements, and expectations, elaborate, and defend, with the Medical Expert, a conclusion on the overall risk-benefit statement.Identify unanswered questions and residual risks in the Clinical Evidence, and design Post Market Clinical Follow Up activities in collaboration with Clinical Research to address these questions.Defining and developing Clinical Evaluation and analysis methodologies to adapt to a complex and quickly evolving regulatory and scientific framework.Supporting Marketing in the creation and review of collateral and promotional material to ensure alignment of messaging and claims to regulatory compliance, scientific accuracy, and clinical evidence. With the Medical Experts, helping to define, plan, and initiate clinical studies and in vitro tests together with all stakeholders from Clinical Research, R&D, Biomechanics and Regulatory.What you need:Required Skills:Education: University degree (PhD, Masters or equivalent) in a field related to the life sciences or a relevant medical engineering field (biology, physiology, biomaterials, biomedical engineering or similar).Experience: 3 to 5 years of experience in Scientific or Medical Writing, and/or relevant academic or clinical research experience (PhD, Post-doc)Proactive, independent, team player with a strong service mentality.Good analytical and transdisciplinary reasoning, with attention to detail.Preferred Skills:Experience in clinical or regulatory affairs preferredExperience with orthopedic or trauma devices preferredTravel Percentage: 10%