• Clinical Research Studies…

    DRT Strategies, Inc. (Silver Spring, MD)
    …effective drugs and biologics are available to the American people. Job Summary: The Clinical Research Studies SME will provide administrative support ... Overview DRT Strategies delivers expert management consulting and information technology (IT) solutions...procedures. Responsibilities: + Provide SME support to clinical research studies via the… more
    DRT Strategies, Inc. (08/22/25)
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  • Scientific Subject Matter…

    Koniag Government Services (Silver Spring, MD)
    **Koniag IT Systems, LLC,** a Koniag Government Services company, is seeking a Scientific Subject Matter Expert II to support **KITS** and our government ... more. Koniag IT Systems is seeking an exceptional Scientific Subject Matter Expert II to...Expertise in specific scientific or medical domains (eg, biotechnology, clinical research , drug development) + Certifications or… more
    Koniag Government Services (08/13/25)
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  • Clinical Research Medical Director…

    Amgen (Washington, DC)
    …unique contributions to serve patients. The dynamic professional we seek is a subject matter expert with these qualifications. **Basic Qualifications:** MD ... of other therapeutic areas will be required. + Provide subject matter expertise with regards to oncology...vendor or within a pharmaceutical/biotech company supporting imaging in clinical oncology studies . + Expert … more
    Amgen (07/19/25)
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  • Senior Manager, Clinical Project Management

    Sumitomo Pharma (Washington, DC)
    …to all applicable regulations and requirements. + Provides input as the subject matter expert for the assigned studies during regulatory inspections. . ... early- to late-stage assets, we aim to accelerate discovery, research , and development to bring novel therapies to patients...and vendors. + Oversees and monitors the management of clinical studies ensuring they are conducted in… more
    Sumitomo Pharma (09/03/25)
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  • Clinical Quality Operations Manager…

    Merck (Washington, DC)
    …Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide. + Acts as the subject matter expert and primary point of contact for ... of the quality management system are in place for studies conducted in partnership with non-commercial organizations (eg NGO,...is preferred. **Prerequisites:** + Minimum of 6 years in clinical research including at least 2 years… more
    Merck (09/09/25)
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  • Digital Medicine, Director

    Amgen (Washington, DC)
    …pragmatic trial strategies, and digital health initiatives. This person will serve as a subject matter expert ( SME ) and strategic partner to ... decisions. **Study & Product Team Support:** + Serve as SME to product and clinical study teams...health technologies. + Proven experience implementing digital strategies in clinical research at a global or regional… more
    Amgen (08/23/25)
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  • FDA Ips3 - Principal Systems Architect for FDA CDS…

    DRT Strategies, Inc. (Silver Spring, MD)
    …solve problems related to workflows and data quality, and who can serve as a subject matter expert in meetings with stakeholders. The role demands excellent ... Overview DRT Strategies delivers expert management consulting and information technology (IT) solutions...Food and Drug Administration Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) provides regulatory… more
    DRT Strategies, Inc. (09/03/25)
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