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Keywords: Katalyst Healthcares , Location: South Plainfield, NJ

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CSV Lead

Responsibilities Ensure the lab instruments are calibrated prior to performing IQ/OQ and certify. Produce GxP documentations for the instrument software validation. Own change controls and deviation management Prepare and execute IQ/OQ...

Posted Date: 12 Oct 2024

Global Regulatory Strategist

Roles & Responsibilities: Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives. Develop strategic dir...

Posted Date: 10 Oct 2024

Regulatory Affairs, Associate Director

Roles & Responsibilities: Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products ...

Posted Date: 10 Oct 2024

Clinical Data Manager

Responsibilities: Review and apply data mappings for customer specific data exports. Perform peer review / QC of data export programming. Produce data transfers via data export files and/or web services. Work with customers to speci...

Posted Date: 05 Oct 2024