Unknown Company

MDR - Sr Prin Clinical Research Spec

st paul, mn • Posted 2 weeks ago
Onsite Full Time Life
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.

MDR - Sr Prin Clinical Research Spec in st paul at Unknown Company

This position is listed as full time and onsite.

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