Sr Clin Eval Med Writer

Job Title: Sr. Clinical Evaluation Medical WriterLocation: Mounds View, MN (Onsite – 4+ days/week)Duration: 24 MonthsJob ID: 25193Pay: $50–$55/hrRole SummaryLead and support end-to-end clinical evaluations (CERs) by analyzing clinical evidence to assess product safety, performance, and risk for medical devices in compliance with global regulatory requirements.Key ResponsibilitiesConduct clinical evaluations (CERs, clinical dossiers) using clinical, literature, and preclinical dataAnalyze data to assess safety, performance, risk/benefit, and evidence gapsDevelop search strategies and manage literature reviews (e.g., ReadCube)Collaborate with R&D, Clinical, Quality, Regulatory, Marketing teamsSupport regulatory submissions and respond to agency queriesPrepare clear, compliant clinical documentation and reportsPerform state-of-the-art assessments and risk evaluationsManage document timelines, reviews, and approvalsProvide mentorship and process improvement supportMust-Have RequirementsClinical Evaluation experience (end-to-end CER development)4+ years (or 2+ with advanced degree) in clinical research/evaluation/evidenceStrong experience in medical writing & regulatory documentationExperience with literature review tools (ReadCube preferred)Knowledge of global clinical/regulatory requirementsMust be local to Mounds View, MN & work onsiteNice to HaveExperience with cardiac rhythm management devicesExperience interacting with regulatory agencies