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Ji Lin

Director Sr Manager @Abbott

Chicago, IL, US
EMAILS
j•••••@abbott.com
MOBILE NUMBERS
+13•••••••73

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WORK HISTORY

Jan 2014 — Present

Director Sr Manager @Abbott

ADD Medical Affairs Medical leader of clinical assay development team and lead MA physician Work with cross functional teams to ensure safety and efficacy of diagnostic products. Responsibilities: Translate medical needs into user needs and product development requirement; provide inputs for clinical study design; update medical affairs best practice documents Provided medical assessment of adverse events and device performance issues Assist Marketing with development of medical inputs, comparisons of “state of the art” and expansion of portfolio Provide medical assessment/justification to support regulatory submissions and Clinical affairs Training and mentoring of colleagues and junior scientist/ physicians Achievements: • Medical Oversight for clinical development of COVID-19 EUA diagnostics • Medical Oversight for clinical development of recent (2022) high sensitivity troponin US launch • Successful global launch of multiple Alinity ci core laboratory assays covering cardiac, endocrine, oncologic, infectious diseases, clinical chemistry, and other specific therapeutic areas (drug of abuse/DOA, therapeutic drug monitoring)

SKILLS

FdaLeadershipGmpMedical DevicesPharmaceutical IndustryBiomarkersManufacturingAssay DevelopmentRadioimmunoassayChange ControlValidationV&VBiotechnologyIch GuidelinesObesityDesign ControlCapaCancerProduct Life CycleMedicineAnalytical SkillsLife SciencesGlpRisk ManagementInvestigationMolecular DiagnosticsPresentationsFmeaReagentsLifesciencesQuality SystemDesign of ExperimentsClinical ResearchCross-Functional Team Leadership

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