- Merck & Co. (Rahway, NJ)
- …clinical development teams and the operational/executional arms within the business. The Program Clinical Supplies Project Manager serves as the primary ... at clinical and development related meetings.- Working independently, the Program Clinical Supplies Project Manager designs strategic and operational plans… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early ... clinical space, determining and implementing the initial ...the Common Technical Document (CTD) and label, including relevant compound/ program life-cycle management.The successful candidate will have an essential… more
- Merck & Co. (Rahway, NJ)
- …technical solutions with the highest value, that improves the way we run our clinical trials for our patients, our partners, and our employees.Candidate will have a ... Office (PMO) for one of our Company's Enterprise-wide Accelerate multiyear program , that focuses on technology and process transformation, simplification and… more
- Merck & Co. (Rahway, NJ)
- …opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions, ... will preferably have experience with high concentration biologics to support clinical and commercial development. Maintaining a strong network internally and across… more
- Merck & Co. (Rahway, NJ)
- …some overnight. Primary Responsibilities Develop professional relationships and communicate with national and regional scientific leaders to ensure access to medical ... have a medical contact within the company.Upon request from Global Clinical Trial Operations (GCTO), support Company-Sponsored Trials to enhance the understanding… more
- Merck & Co. (Rahway, NJ)
- …programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into ... or related field plus 9 years SAS/R programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences,… more
- Merck & Co. (Rahway, NJ)
- …stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound progression of portfolio, initiatives for ... driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report to… more
- Merck & Co. (Rahway, NJ)
- …Company's biologics pipeline. We work closely with colleagues in Discovery, Pre- clinical and Early Development to rapidly develop manufacturing processes for diverse ... biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and… more
- Merck & Co. (Rahway, NJ)
- …PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs ... expertise in several areas, including: -Responsible for achieving results on major program drivers by implementation of one or more novel quantitative approaches… more
- Insmed Incorporated (New York, NY)
- …pharmacy, and health outcomes influencers within the territory for assigned National and Regional accounts .Provide timely, fair balanced, objective, scientific ... and healthcare professionals Work cross-functionally with Commercial colleagues (Key Account Directors and Sales) to coordinate proper response to customer's… more
- Merck & Co. (Rahway, NJ)
- …(PK) and pharmacodynamics (PD) analysis, model-based meta analysis (MBMA), clinical trial simulations (CTS), disease progression modeling and Artificial Intelligence ... through the following responsibilities.Responsible for achieving results on major program deliverables by identifying, driving the development and implementation of… more
- Merck & Co. (Rahway, NJ)
- …team of approximately 5-10 pharmacometricians to achieve results on major program drivers by identifying and implementing quantitative approaches (for eg, ... models, quantitative system pharmacology (QSP) and disease progression models, clinical trial simulations, comparator modeling) that seek to improve cycle… more
- Merck & Co. (Rahway, NJ)
- …and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.A ... transfer of assays. Plan assay optimization and documentation to meet program deadlines.Authoring and reviewing internal technical reports, sections of regulatory… more
- Merck & Co. (Rahway, NJ)
- …technology evaluation and shaping scientific strategy both at the platform and program level.Project management and/or scientific over-sight of work outsourced to ... Clinical Research Organizations (CROs)#AR&DCurrent Employees apply HERE Current Contingent...race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or… more
- Merck & Co. (Rahway, NJ)
- …and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.A ... transfer of assays. Plan assay optimization and documentation to meet program deadlines.Authoring and reviewing internal technical reports, sections of regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts ; employee assistance program ; tuition reimbursement program ; ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...relationships with internal and external stakeholders at trial and program level to ensure alignment of priorities and deliver… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts ; employee assistance program ; tuition reimbursement program ; ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …contracting, managed markets strategy, or value communication within payer marketing, national account management, consulting, and/ or market access strategy ... Finance, Brands, Medical Affairs, HEOR, Commercial Pipeline, Field Sales, Account Management, Analytics, Investor Relations, Value Communication and Contracting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts ; employee assistance program ; tuition reimbursement program ; ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...financial metrics on an ongoing basis to study and program teams. In collaboration with internal and external partners,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …providing support to implement and maintain computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be ... collaboration across relevant cross functional groups to establish a strong, compliant program to enable robust production, testing and release of product to… more
