MDR - Sr Prin Clinical Research Spec
Artech
MDR - Sr Prin Clinical Research Spec 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. 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. Artech
Vacancy posted 15 hours ago
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