- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Investigator I or Investigator II as part of the Technical Operations team ... based in Raritan, NJ. Role OverviewThe Investigator will be part of Technical Operations team and will be responsible for the investigations of Operations QIs to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgetsCollect ... to supervisor's attention.Track study metrics such as site start-up, Investigator /site performance, recruitment, regulatory documents, TMF filing and QC activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(TLF) and CSR safety narrativesMay lead the development and updates of the Investigator 's Brochure (IB): author the clinical section and lead the development of the ... other sections in collaboration with the other authoring functionsAccountable for Protocol content/study design developmentContributes from a medical strategy standpoint to the development of clinical sections of study-level documents (eg, protocol,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documentsAuthors or oversees the development of safety sections of Investigator 's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data ... Sheet (CCDS), Risk Management Plan(s) (RMPs)Collaborates with PSL(s) and cross-functional team for assigned product(s) to author or contribute to regulatory authority requests or communicationEnsures consistent and unified safety message throughout multiple… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and CSR safety narratives- May lead the development and updates of the Investigator 's Brochure (IB): author the clinical section and lead the development of the ... other sections in collaboration with the other authoring functions- Accountable for Protocol content/study design development- Contributes from a medical strategy standpoint to the development of clinical sections of study-level documents (eg, protocol,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(TLF) and CSR safety narrativesMay lead the development and updates of the Investigator 's Brochure (IB): author the clinical section and lead the development of the ... other sections in collaboration with the other authoring functionsAccountable for Protocol content/study design developmentContributes from a medical strategy standpoint to the development of clinical sections of study-level documents (eg, protocol,… more
- Merck & Co. (Rahway, NJ)
- …working for a health authority/board of health as an inspector, investigator , product reviewer, compliance officer, or other GMP/regulatory roleStrong background in ... data analyticsDemonstrated ability to creatively use multiple methods of analysis to decipher large datasets, including text-based datasets (eg, lists of compliance observations)Strong background and technical understanding of vaccines and/or biologicsCurrent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to team members and track them to completionFollow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.Perform ... investigations and train new investigators.Collaborate with team to determine if corrective actions adequately addressed root cause of NC event.Support tracking of deviations, events and key process parameters and provides reports to management on trending,… more
- Eisai, Inc (Nutley, NJ)
- …certifications and maintain statuses of study team members Assist with investigator meeting planning, including entering clinical meetings into Eisai internal ... systems Attend investigator meeting when applicable Performs other tasks or responsibilities as assigned Financial Contributions: Track invoices and support the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator 's Brochure (IB), integrated safety summaries, abstracts and planned publications ... by participation in project/trial groups/teams established, as appropriate and conducts Investigator training as required Provide answers to enquiries from HAs and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator 's Brochure (IB), integrated safety summaries, abstracts and planned publications ... by participation in project/trial groups/teams established, as appropriate and conducts Investigator training as required Provide answers to enquiries from HAs and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …limited to research partnerships and other collaboration agreements sponsorships, Investigator Sponsored Studies (ISS) and supplier service agreements Ensures ... compliance with government rules and regulations relating to the contractual and budgetary aspects of contracting with health care systems, health care professionals and organizations Maintains a deep understanding of CMR strategy and industry trends to drive… more
- Genmab (Plainsboro, NJ)
- …a liaison to project teams and CROsAssists to prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warrantedRequirementsPhD, Pharm D, MS or ... equivalent degree preferably within the medical, biological, pharmaceutical science or related disciplineClinical research experience preferred.Prior oncology/hematology drug development experience is a plusAbility to work in a project oriented matrixed team… more
- Genmab (Plainsboro, NJ)
- …of US needsProvides scientific input and strategic direction to the investigator -sponsored trial program for solid tumor assets/disease and participates in the ... review of all US ISTsEnsures the delivery of timely, accurate and succinct communication of fair-balanced clinical and scientific presentations to healthcare professionals, both proactively and in response to requests for information, consistent with… more
- Genmab (Plainsboro, NJ)
- …trial result meetings Review and approve the CSR Attend trial and investigator meetings if/as needed Collaboration with Genmab Global Drug Safety:Participate in ... definition, review, and approval of data packages for Data Monitoring Committees Review and approve any amendments, corrections, and updates of data packagesExperience:Master's or PhD in a statistical discipline with 8+ of experience in relevant technical… more
- Genmab (Plainsboro, NJ)
- …Protocols and amendments, Trial Reports, Trial plans, eCRFs/CRFs, TMFs, Investigator 's Brochures, Subject Informed Consent, Development Safety Update Reports, ... periodic safety update reports, Integrated Safety Summaries and scientific articlesCommunicate any changes in the medicinal product risk profile internally and externally.Interface cross-functionally at all levels in the organization as well as with external… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for submissions, eg, clinical protocols and study reports, preclinical reports, investigator brochures, application summary documents, etc. Research and analyze the ... evolving competitive and regulatory landscapes to maintain current knowledge Effectively managing timelines while working in a fast-paced and dynamic environment across both time zones and cultures Physical Requirements 0-10% overnight travel required. Ability… more
- MTA (New York, NY)
- Equal Opportunity Investigator Job ID: 8544 Business Unit: MTA Headquarters Location: New York, NY, United States Regular/Temporary: Regular Department: Date Posted: ... Nov 7, 2024 Description JOB TITLE : Level I: Junior Equal Opportunity Investigator Level II: Equal Opportunity Investigator Level III: Senior Equal Opportunity … more
- Bank of America (New York, NY)
- Global Financial Crimes Sr. Investigator Charlotte, North Carolina;New York, New York; Atlanta, Georgia; Plano, Texas; Dallas, Texas; Chicago, Illinois **Job ... are adequately documented. The Senior Global Financial Crimes ("GFC") Investigator , under broad supervision, partners with investigators to ensure investigative… more
- MTA (New York, NY)
- Senior Equal Opportunity Investigator Job ID: 4633 Business Unit: MTA Headquarters Location: New York, NY, United States Regular/Temporary: Regular Department: Date ... Posted: Nov 7, 2024 Description JOB TITLE: Senior Equal Opportunity Investigator SALARY RANGE: $105,000 - $116,133 HAY POINTS: 551 DEPT/DIV: Department of Diversity… more
