Job title: Senior Staff Specialist, Clinical Affairs
Job description: Why join Stryker? We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting Our total rewards package offering includes bonuses, healt
Why join Stryker? We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific. Who we want: Dedicated achievers . People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Persuasive influencers .People who understand market positioning and can use their relationship skills and depth of knowledge to secure buy-in, cooperation, and loyalty. Hard-working winners .Confident, competitive and results-oriented salespeople who create a track record of success. Collaborative partners . People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. Analytical problem solvers . People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues What you will do: Drive 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). Designingcompliant and sustainable literature search strategies, and performingcomplex literature queries toretrievepublished clinical data, Identifying, appraising,and analyzingall 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. Analyzingthe 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 regulatoryrequirements,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 anddevelopingClinicalEvaluation and analysis methodologies to adapt to a complex and quickly evolving regulatory and scientific framework. SupportingMarketing 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, helpingto 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: Education: University degree (PhD, Master’s or equivalent) in a field related to the life sciences or a relevant medical engineeringfield (biology, physiology, biomaterials, biomedical engineering or similar). Experience: 12+years of experience in Scientific or Medical Writing, and/orrelevantacademicor clinicalresearch experience (PhD, Post-doc) Experience in clinical or regulatory affairs preferred Experience withorthopedic or trauma devices preferred Know someone at Stryker? Be sure to have them submit you as a referralprior to applyingfor this position. Learn more about ouremployee referral programat
Location: Bangalore, Karnataka
Job date: Thu, 27 Jan 2022 23:08:47 GMT
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