- Merck & Co. (Rahway, NJ)
- … development teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager ( Program CSPM) serves as the ... spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs strategic and operational plans for all clinical … 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
- Merck & Co. (Rahway, NJ)
- …strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development. The successful candidate will have an essential strategic ... strategies and interact with various stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role… 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)
- …area for our company; where no regulatory guidance exists; where the program is accelerated; has an external business partner; there are multiple indications, ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Provides direction to the Global… more
- Merck & Co. (Rahway, NJ)
- …one or more V&I, Outcomes Research teams across the Oncology GI cancers program . Primary Responsibilities: Support value evidence teams in Oncology and contribute to ... access in collaboration with internal teams, and provide input into clinical , payer/access, marketing and value evidence generation strategies and programs.In… more
- Merck & Co. (Rahway, NJ)
- …and inhaled dosage forms.Provide active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across ... with exposure to all stages and aspects of development (preclinical, clinical , and commercial) and cGMP industrial background.Demonstrated scientific leadership and… more
- Merck & Co. (Rahway, NJ)
- …risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead ... ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key Ofunctions.Lead the Device… 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 and ... expertise in several areas, including:-Responsible for achieving results on major program drivers by implementation of one or more novel quantitative approaches… more
- Merck & Co. (Rahway, NJ)
- …(PK) and pharmacodynamics (PD) analysis, model-based meta analysis (MBMA), clinical trial simulations (CTS), pediatrics modeling and disease progression modeling. ... the following responsibilities . Responsible for achieving results on major program deliverables by identifying, driving the development and implementation of one… more
- Merck & Co. (Rahway, NJ)
- …execute, design verification strategies for assigned drug-device combination product program (s) for successful clinical introduction(s) and commercial market(s) ... and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal… more
- Merck & Co. (Rahway, NJ)
- …You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will include:-Driving our company's Pipeline:-Leading ... process development.Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices (including method development… more
- Merck & Co. (Rahway, NJ)
- …products. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will include: - Driving our Company's ... development. Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices (including method development… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pharmaceutical sales, marketing, market insights, analytics, pricing, contracting, managed markets, national account management, finance, or consulting OR a ... Executes key programs that will drive long-term profitable relationships with key accounts and the managed markets channel overall. Responsible for both inline and… 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)
- …/ regulatory documentation. Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across ... with exposure to all stages and aspects of development (preclinical, clinical , and commercial) and cGMP industrial background.Capable of leading formulation… 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)
- …enzyme processes that meet target yield, activity, and purity to ensure clinical and commercial drug substance needs. This individual will play a critical ... model-based approaches.-Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Finance, Brands, Medical Affairs, HEOR, Commercial Pipeline, Field Sales, Account Management, Analytics, Investor Relations, Value Communication and Contracting ... product launches within responsible therapeutic area, with direct implications for account team planning and implementation. Entails coordinating market research and… more
