MDR - Sr Prin Clinical Research Spec

Job Title: MDR - Sr Prin Clinical Research Spec
Job ID: 26993
Duration: 12 Months
Location: Mounds View Minnesota 55112
Pay Rate:$60.00 - $65.00/hr.

Key Responsibilities:

• Lead authoring and critical review of Clinical Evaluation Reports (CERs) and other scientific/regulatory documents.
• Analyze complex clinical data and prepare clear, accurate, and defensible scientific summaries.
• Serve as a clinical SME, providing strategic clinical input to leadership and cross-functional teams.
• Support global clinical-regulatory submissions and medical affairs activities.
• Ensure documents are scientifically sound and aligned with regulatory, clinical, and commercial needs.

Required Qualifications:

• 10+ years (or 8+ years with an advanced degree) in Clinical Research/Clinical Evaluation.
• Extensive medical writing and clinical evidence development experience.
• Expertise in authoring/editing CERs, clinical evaluation, and scientific/regulatory documentation.
• Strong knowledge of GCP, clinical trials, regulatory submissions, and clinical data interpretation.
• Excellent scientific communication and stakeholder management skills.