- Astellas Pharma (Northbrook, IL)
- …selection and stratification in clinical studies across all phases of drug development. As a Diagnostic Regulatory Strategy Lead , you will be the primary ... and late-stage drug programs. + Provide expert guidance on diagnostic regulatory pathways including IVDR (EU), FDA...mitigations + Lead and/or support preparation of diagnostic related regulatory submissions including IVDR clinical… more
- Amgen (Washington, DC)
- …a biomarker assay to marketed Diagnostic to support the clinical development strategy for regulatory approval and commercialization. As such, the Dx group ... support therapeutic product teams, including regulatory approval, commercialization, and diagnostic lifecycle plans + Lead efforts to oversee assay… more
- Pfizer (Groton, CT)
- …medicinal and diagnostic products. Through your expertise, you will be the diagnostic regulatory liaison on the project team throughout the product lifecycle ... Diagnostics, and other key stakeholder to ensure the associated diagnostic submissions are defined, executed, and the regulatory... requirements are met and aligned with the global regulatory strategy of the medicinal product. +… more
- Regeneron Pharmaceuticals (Armonk, NY)
- … impacts and operational considerations _Diagnostics Project Execution:_ + Working with the Diagnostic Strategy Lead , define the diagnostic delivery ... etc.) within Regeneron's drug development pipeline in partnership with Diagnostic Strategy Leads and IVD Regulatory...Dx/CDx activities, status, budget and timelines + Support Dx/CDx Strategy Lead and Dx/CDx management with information… more
- GE HealthCare (Waukesha, WI)
- …the development and lifecycle management** of a diverse portfolio of diagnostic cardiology algorithms, ensuring regulatory compliance, clinical efficacy, and ... This Senior Director role reports to the CTO for Diagnostic Cardiology (DCAR) and is responsible for defining and...for GE HealthCare internal and external stakeholders. You will lead a team of high-performing technologists and clinical experts… more
- Sanofi Group (Cambridge, MA)
- …(eg, ADA, biomarker, immunogenicity, and exploratory translational tests) to meet clinical and regulatory needs. + Lead the transfer of assays from internal ... with regulatory , clinical, medical, and commercial teams to integrate diagnostic testing into clinical trial and product launch strategies. + Contribute to… more
- Sanofi Group (Morristown, NJ)
- … impact assessments for proposed product changes + May serve as a regional/local regulatory lead and point of contact with medical deviceHealth Authorities for ... Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT,...prioritization, objectives and setting clear expectations for the device regulatory strategy , including a global labeling … more
- GE HealthCare (Waukesha, WI)
- … submissions, and marketing, based on intended clinical applications, business, and regulatory strategy + Establish and cultivate strategic academic partners ... and national meetings of professional societies + Manage medical materials for regulatory , marketing, and commercial activities + Lead medical reviews of… more
- GE HealthCare (Waukesha, WI)
- …driving the successful execution of New Product Introductions (NPIs) in the Diagnostic Cardiology business of GE HealthCare. This strategic leader defines and ... the timely delivery of innovative, high-quality products and solutions for the diagnostic electrocardiography (ECG) business. As the leader of the Program Management… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …through project transition. The Customer Experience Management is key to the success of Diagnostic Solutions strategy and is required to drive a high level of ... a **maker of possible** with us. **JOB SUMMARY:** The Project Manager - Diagnostic Solutions, is responsible for the full Implementation Cycles associated with the… more
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