- 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
- J&J Family of Companies (Horsham, PA)
- …status of clinical study activities + Review and assessment of new clinical study proposals + Lead company sponsored study development from protocol ... Solid Tumor group and will actively participate and may lead aspects of the development, oversight, and execution of...clinical pharmacology, etc.) + Monitor, review and analyze clinical trial data + Assist with investigation … 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
- Endo International (Horsham, PA)
- …reviews controlled documents (eg SOPs) required for compliance. Quality Systems & CAPA Investigations + Contributes to and may lead operational teams in the ... Review + Supports the QA batch release functions for cGMP commercial, clinical , and development manufacturing and distribution activities from the local, contract… 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
- 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
- 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
- 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
- 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
- Merck (West Point, PA)
- …technology transfer to internal and external manufacturing sites, manufacturing investigations , process validation, and authoring of regulatory submissions. Under ... downstream and/or overall drug substance teams focusing on late-stage clinical process development, characterization, and technology transfer and validation with… 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
- 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
- Merck (West Point, PA)
- …authoring of regulatory submissions and support of significant manufacturing investigations . The group is responsible for establishing the science, engineering ... scientist/engineer, to advance and commercialize Innovative Large Molecules to clinical and commercial manufacturing sites. This person would be accountable… more
- Actalent (Sellersville, PA)
- …commercial and clinical batches, Operational, QC, and QMS projects. + Lead and support with customer requests, quality events, and other activities. + Maintain ... administrator for creating CAPAs, change controls, deviations, and laboratory investigations . + Exhibit strong communication and problem-solving skills while leading… more
- Actalent (Sellersville, PA)
- …commercial and clinical batches, Operational, QC, and QMS projects. + Lead and support with customer requests, quality events, and ensure documents are current ... administrator for creating CAPAs, change controls, deviations, and laboratory investigations . + Exhibit strong communication and problem-solving skills while leading… 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
- Merck (West Point, PA)
- …authoring of regulatory submissions and support of significant manufacturing investigations . The group is responsible for establishing the science, engineering ... scientist/engineer, to advance and commercialize Innovative Large Molecules to clinical and commercial manufacturing sites. This person would be accountable… more