Senior Medical Writer

Clinical Evaluation Medical Writer Location: Mounds View MN (Hybrid – 4 Days Onsite) Duration: 24+ Months Contract Pay Rate: $53.95 – $61.15/HourPosition SummarySeeking an experienced Sr. Clinical Evaluation Medical Writer to support clinical evaluation activities for medical devices. The role involves developing CERs, analyzing clinical evidence, supporting regulatory documentation, and collaborating with cross-functional teams to ensure product safety and compliance.Top Skills: End-to-end Clinical Evaluation experienceMedical device industry experienceCardiac Rhythm Management device experience preferredExperience with literature management tools such as ReadCube or EndNoteKey ResponsibilitiesDevelop and support CERs, clinical dossiers, and regulatory documentsAnalyze clinical, literature, and preclinical data to evaluate product safety and performanceIdentify evidence gaps and support risk/benefit assessmentsConduct literature searches and maintain clinical evaluation documentationCollaborate with R&D, Clinical, Regulatory, Quality, and Marketing teamsSupport regulatory responses and clinical evaluation strategiesReview technical documentation and ensure compliance with global regulationsManage document timelines and support process improvement initiativesQualificationsBachelor’s degree with 4+ years of relevant experienceORAdvanced degree with 2+ years of relevant experience