- Novo Nordisk Inc. (Plainsboro, NJ)
- …as well as the full range of treatment options available and associated clinical outcomes Leverages detailed knowledge of both Novo Nordisk and competitor products ... customer account approaches Follows-up with internal and external stakeholders to review product value, quality of care and account satisfaction Physical… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for leading the development and ... as relevant to support optimized labeling. Ensure proper development, review , approval, implementation, maintenance, distribution and tracking of labeling documents… more
- Tris Pharma (Monmouth Junction, NJ)
- …/Paralegal to join our small, but experienced, in-house Legal team.The Contracts Manager /Paralegal supports the Legal department in the review , drafting and ... types and agreements (ie, NDAs, service agreements, supply, sales and clinical vendor agreements, etc.) Experience handling multiple aspects of legal support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager of CRA Monitoring Oversight and Excellence is responsible for the support ... study/CRO plans across the portfolio.Ensure study-specific monitoring plans meet the above standards. Review quality oversight plans that CRO CRAs have in place to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Manager , Global Medical Affairs Oncology Publications works with GMA Oncology Publications ... in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production...compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programmer is a member of the Biostatistics and Data Management ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Operations Manager is an exempt level position working within Technical...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... and clinical study report (CSR): Leads statistical activities for complex...for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Responsibilities:- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... and clinical study report (CSR): Leads statistical activities for complex...for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- VNS Health (Manhattan, NY)
- OverviewOversees the completion and approval of all clinical utilization documentation, including Start of Care, Re-certification, Resumption of Care, Follow up ... and appropriate visit utilization using evidence-based practices to provide positive clinical outcomes and efficient use of resources. Identifies and addresses… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager , Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and ... interpretation of study data of a clinical development program. The Sr. Manager leads...Expanded Synopsis and may author clinically relevant sections and review other scientific portions of clinical trial… more
- Bristol Myers Squibb (Princeton, NJ)
- …site and CRA training materials and present these at SIVs and Investigator meetings + Review clinical narratives + Monitor clinical data for specific trends ... co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members **Position...and development team meetings as required + Conduct literature review + Submit clinical documents to TMF… more
- Mount Sinai Health System (New York, NY)
- …in the NY/NJ region. MSHS, World Trade Center Health Program (WTCHP) seeks a Clinical Pharmacy Manager that reports to Senior Manager , Pharmacy Benefits ... under the direction of the WTCH medical leadership. The Clinical Pharmacy Manager will have direct patient...practitioners as required + Performing prescription audits such as review to improve generic medication use, prescribing patterns and… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Clinical Program Manager , Clinical Command Center is a Registered Professional Nurse, Physician Assistant, or Nurse Practitioner, who ... functions of health-system throughput, transfer center, quality, and delivery of care. The Clinical Program Manager , Clinical Command Center participates in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Senior Manager Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned ... budget, TMF, and study drug accountability + Contributes to clinical study report writing and review + Facilitates and contributes to study level lessons learned… more
- Pfizer (New York, NY)
- … trials and ability to assess and determine study requirement from protocol review + Working knowledge of clinical research, Food and Drug Administration ... You Will Achieve** It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility of our clinical data.… more
- Taiho Oncology (Princeton, NJ)
- Sr. Manager , Clinical Research Scientist Pleasanton, CA, USA * Princeton, NJ, USA Req #383 Thursday, August 8, 2024 Looking for a chance to make a meaningful ... cancer treatment and improving patients' lives. As a Senior Manager , Clinical Research Scientist, you will play...NDA/MAA registration documents and publications. + Ability to critically review and interpret Clinical data. The pay… more
