- Humana (Trenton, NJ)
- …driving health outcomes and cost-effective care for our members. We are seeking a Clinical Investigation Lead to provide strategic direction to drive ... owners across Humana to drive solutions forward. In this role you will lead quantitative and qualitative investigations to identify actionable insights and bring… more
- Sanofi Group (Bridgewater, NJ)
- …Scientist's position is to support the Clinical Research Director (CRD) and/or clinical lead in the medical/scientific contribution for the clinical ... as needed. He/she ensures appropriate review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams)… more
- SERV Behavioral Health System (Lawrenceville, NJ)
- …and reporting components of the organization. + Conduct ongoing review of clinical supervisor/ lead counselor case files to ensure compliance with federal, ... Counseling, Substance Abuse Disorder. JOB SUMMARY: Responsible for overseeing the clinical and administrative operations of service delivery for the assigned county… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Our Clinical Supply Operations is responsible for the supply of drug product ... administered to patients in clinical studies worldwide. In Global Product Development and Supply...high level within the department. + Leads root cause investigations for process deviations and assigns Corrective/Preventative Actions. +… more
- Integra LifeSciences (Princeton, NJ)
- …products/processes from R&D to full-scale manufacturing, following Design Control Procedures. + Lead and manage efforts to create novel processes, leading to full ... new and/or improved processes. + Apply experience with manufacturing process equipment to lead the selection and/or design of equipment from prototype and full scale… more
- ThermoFisher Scientific (New Brunswick, NJ)
- …step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel ... frameworks for clinical research through our PPD clinical research...Provides technical expertise and troubleshooting for technical problems and investigations . + Participates in the preparation and the critically… more
- Bristol Myers Squibb (Princeton, NJ)
- …while fostering accountability across all levels of the organization. + ** Investigations :** Lead complex investigations covering sensitive, ambiguous, ... mitigate business continuity, reputational and liability risks. + **Cultural Leadership:** Lead across seams/matrix to create a culture centered around environmental… more
- Bristol Myers Squibb (Princeton, NJ)
- …practices while fostering accountability across all levels of the organization. + ** Investigations :** Lead investigations covering sensitive, ambiguous, and ... levels of the organization, maintaining healthy vulnerability. + **Cultural Leadership:** Lead across matrix to create a culture centered around environmental and… more
- Kelly Services (Plainsboro, NJ)
- …regulatory guidelines for Medical Device Manufacture. As required, conduct Non-Conformance Investigations , assist or lead in the prompt implementation of ... personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs. + Effectively implement problem solving skills… more
- Taiho Oncology (Princeton, NJ)
- …and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources ... assigned to him/her, including review and analysis of safety data from clinical trials and from post-marketing sources, providing medical expertise to assigned… more
- MTF (Edison, NJ)
- …tissue grafts from human donors that are used in a growing array of clinical applications - positively affecting lives across the globe. As a global nonprofit ... processing documents/procedures/specifications are complete, accurate, and current. 6. Perform investigations and root cause analysis for NCR's. Implement corrective… more
- Bristol Myers Squibb (Princeton, NJ)
- …etc) to enable contemporary, risk based, solutions to challenging scenarios. + Lead and/or support critical safety related investigations , ensuring root cause ... safety, to support both operations and capital projects. The Executive Director will lead a global team of technical experts, deploying capabilities and personnel to… more
- Hackensack Meridian Health (Edison, NJ)
- …the unit. 4. Lead or participates with quality improvement projects. 5. Lead or conducts root cause analysis investigations . 6. Assure unit regulatory ... staffing, supports throughput, quality and safety outcomes, staff competency, hiring, clinical and staff corrective actions, unit efficiency, quality care and other… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …identifying, evaluating, and screening qualified research sites for company sponsored clinical investigation + Actively participates in executing USMAO strategy ... molecular pathways, mechanism of action Takeda Oncology products including clinical outcomes and research opportunities. + Formulate and keep...at medical conferences and may "co- lead " a medical conference to inform for being a… more
- Catalent Pharma Solutions (Somerset, NJ)
- …Supports problem resolution and communication to all affected internal departments. + Lead investigations related to material discrepancies and Trackwise events ... business unit. On site we have our state-of-the-art laboratory, clinical , and commercial manufacturing plant for oral dose forms...chain + Maintain trackers of Order status, PO status, lead time, and receipt for all goods + Source… more
- BeiGene (Hopewell, NJ)
- …compliance with FDA/EU regulation, covering cGMP for commercial medicinal products and clinical material for human use. + Significant participation in regulatory and ... carry out the review and release of materials and product for commercial and clinical products in accordance with cGMPs. + Ensuring appropriate investigation of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of the CSPV solution that satisfies the business process vision + Lead platforms and systems design and optimization to deliver best-in-class solutions **Change ... items, and business as usual. + Leads or assists in the tracking and investigation of quality and compliance issues **Other** + Review and update of DMA Procedures… more
- BeiGene (Hopewell, NJ)
- …compliance with FDA/EU regulation, covering cGMP for commercial medicinal products and clinical material for human use. + Significant participation in regulatory and ... review and approval of batch documentation and product release for commercial & clinical products in accordance with GMPs. + Ensuring appropriate investigation … more
- Integra LifeSciences (Plainsboro, NJ)
- …products/processes from R&D to full-scale manufacturing, following Design Control Procedures. + Lead and manage efforts to create novel processes, leading to full ... new and/or improved processes. + Apply experience with manufacturing process equipment to lead the selection and/or design of equipment from prototype and full scale… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Regeneron GVP Quality Management Lead (QML) is a key position that we believe will guide and lead all aspects of quality and compliance within global ... Affairs, Regulatory, Commercial, etc. + Participate in process improvement activities, lead projects in support of quality objectives, and support inspection… more