Cardiac Monitoring, Clinical Assessment, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Trial, Data Analysis, Document Management, Healthcare Quality, Marketing, Medical Equipment, Medical Writing, Mentoring, Performance Analysis, Process Improvement, Product Safety, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Research & Development (R&D), Risk, Risk Analysis, Strategic Planning, Time Management, Writing Skills
Job Title: Sr. Clinical Evaluation Medical Writer
Location: Mounds View, MN (Onsite – 4+ days/week)
Duration: 24 Months
Job ID: 25193
Pay: $50–$55/hr
Role Summary
Lead 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 Responsibilities
- Conduct clinical evaluations (CERs, clinical dossiers) using clinical, literature, and preclinical data
- Analyze data to assess safety, performance, risk/benefit, and evidence gaps
- Develop search strategies and manage literature reviews (e.g., ReadCube)
- Collaborate with R&D, Clinical, Quality, Regulatory, Marketing teams
- Support regulatory submissions and respond to agency queries
- Prepare clear, compliant clinical documentation and reports
- Perform state-of-the-art assessments and risk evaluations
- Manage document timelines, reviews, and approvals
- Provide mentorship and process improvement support
Must-Have Requirements
- Clinical Evaluation experience (end-to-end CER development)
- 4+ years (or 2+ with advanced degree) in clinical research/evaluation/evidence
- Strong experience in medical writing & regulatory documentation
- Experience with literature review tools (ReadCube preferred)
- Knowledge of global clinical/regulatory requirements
- Must be local to Mounds View, MN & work onsite
Nice to Have
- Experience with cardiac rhythm management devices
- Experience interacting with regulatory agencies