- BeOne Medicines (San Mateo, CA)
- …will be responsible for leading a small team for developing and implementing regulatory diagnostic and medical device strategies as applicable, for the ... stakeholders. **Essential** **Functions** **of** **the** **job:** + Develop European and/or UK regulatory strategy for the designated program, and contribute to… more
- Cytek Biosciences, Inc. (San Diego, CA)
- …reagent operations strategy and roadmap including required capex, facilities strategy , organization, IT systems, regulatory impact, and business processes ... SUMMARY: The Director/Sr. Director, Reagent Operations will lead and manage reagent manufacturing operations, worldwide distribution and positioning of products… more
- Jobleads-US (Boston, MA)
- …search in the community health center movement. The Head of Talent Acquisition will lead executive recruitment efforts on behalf of CSP's clients, with a focus on ... of current and potential community health center leaders. Executive Search Strategy : Develop and execute comprehensive executive search strategies to identify and… more
- Caris Life Sciences (Irving, TX)
- …early detection cancer plays a critical leadership role in bringing innovative diagnostic solutions to patients. The Vice President of Marketing Early Detection will ... product through planning, developing, implementing and monitoring the product marketing strategy for Caris Life Sciences. **Job Responsibilities** + Product Vision… more
- Epredia (San Francisco, CA)
- …training. Collaborating with pathologists, lab managers, and research scientists, you'll lead discussions on advanced applications and workflows. If you have proven ... the territory. + Develop and implement a successful sales strategy for rapid revenue growth and market share expansion...sales process and closing from Account Executive and other lead generating salespeople. + Report, track, and manage all… more
- Capco, a Wipro Company (Charlotte, NC)
- …and onboarding to transaction processing, fraud management, and collections. + Lead diagnostic assessments of current-state payment systems, customer journeys, ... broad scale programs. **What You'll Get to Do:** + Lead or support client engagements focused on credit card...or support client engagements focused on credit card product strategy , digital payments, issuing/acquiring models, and market entry or… more
- CommScope, Inc. (Sunnyvale, CA)
- …engineering principles + **Establish robust monitoring and alerting** using APM tools, diagnostic dashboards, and early detection systems + ** Lead technical ... BU is looking for a seasoned **Senior Technical Operations Manager** to lead our global operations team in delivering world-class infrastructure performance and… more
- Terumo Medical Corporation (Elkton, MD)
- …management, and preparing detailed technical reports for internal and potentially external/ regulatory bodies. c. Proven ability to lead cross-functional ... complex technical deliverables. **Job Details/Responsibilities** 1. Technical Leadership: a. Lead the technical execution and successful delivery of complex… more
- 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
- 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 (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
- 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …or Madison, New Jersey **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and ... with business needs and enabling timely, compliant submissions + Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee,… more
- Danaher Corporation (Boston, MA)
- …will be fully remote. In this role, you will have the opportunity to: + Lead regulatory strategy and execution for external partnerships and product ... The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and/or Authorities)_ Responsibilities Include but are Not Limited to the Following: + Lead regulatory strategy and execution in collaboration with external ... Senior Regulatory Project Manager is responsible for regulatory strategy development and execution of Companion...of Companion Diagnostics (CDx) and IVD products. The Senior Regulatory Project Manager will provide oversight and lead… more
