- Merck & Co. (Rahway, NJ)
- …Collaborate with systems engineering team to develop robust set of design input requirements based on user needs and target product profile.Gain deep ... industry standards related to medical device manufacturing is a plus.Experience in the design and development of drug delivery systems such as prefilled syringes… more
- Merck & Co. (Rahway, NJ)
- …at least 2 years in managing external partners and suppliers.Proven expertise in design controls, risk analysis , control strategies, design verification ... internal and external manufacturing in the scale-up, development, commercialization, and design transfer of medical devices and combination products, with a focus… more
- Merck & Co. (Rahway, NJ)
- …in medical device, pharmaceutical or in biotech organizations Five plus years in design control, risk analysis and change control management for medical device ... systems and associated prefilled syringe components- Experience with design verification testing- Experience in working with medical device suppliers- Experience… more
- Merck & Co. (Rahway, NJ)
- …projects. -Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis ... submissions and post marketing support.The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups… more
- Merck & Co. (Rahway, NJ)
- …2-3L bioreactor systems .Expertise in upstream lab scale experimental execution, Design of Experiments (DOE), statistical data analysis and presentation of ... lots, control strategies, manufacturing operations, investigation evaluations, and regulatory filings. Design , plan, and execute laboratory experiments to generate high… more
- Merck & Co. (Rahway, NJ)
- …the life of the project, tries to resolve problems during the design and planning phases whenever possible.Provides timely and accurate information and status ... the fieldExpertise in independently conducting and directing the planning, execution, analysis , and documentation of all stages of cell culture process… more
- Merck & Co. (Rahway, NJ)
- …an in-depth knowledge of informed consent medical writing responsibilities, including design , planning, writing, editing, and review of accurate, clear, high-quality ... consent documents.Applies understanding of clinical development, study protocols (eg, design , objectives, and study procedures), relevant regulations, disease areas,… more
- Merck & Co. (Rahway, NJ)
- …experience in some of the following domains: constrained optimization, database design , dynamical systems , machine learning, Bayesian statistical modeling, logic ... Intelligence (BI), Business Processes, Business Process Modeling, Business Technology, Data Analysis , Database Design , Data Engineering, Data Modeling, Data… more
- Merck & Co. (Rahway, NJ)
- …origin;Manage the origin related content on teamsites;Work with global trade management systems to ensure all origin master data and processes are maintained;Oversee ... Free Trade Agreement management activities and provide technical input, if required; Design and maintain country of origin related process (such as processes… more
- Merck & Co. (Rahway, NJ)
- …Human Health (HH) brand/franchise goals, integrated risk management, supply chain design , and continuous improvement of the product's supply chain.-The Director, ... Value Chain Management across all modalities, end-to-end (E2E) supply chain design , strategic scenario planning, capacity evaluations and value chain optimization.… more
- Merck & Co. (Rahway, NJ)
- …tools and integrated platforms that supports the modeling, simulation, and analysis of complex biological, pharmacokinetic, and pharmacodynamic systems .Primary ... epics and key results.Utilize process maps, Information architecture and design -thinking methodologies to clarify problem space, understand pain points and… more
- Merck & Co. (Rahway, NJ)
- …digital analytics, competitive insights, and strategy. This person will help scope, design , and deliver well-defined use cases and deliver on OKRs, aligned to ... of BS (or equivalent) in Data Science, Computer Science, Management Information Systems , IT, or an equivalent scientific/commercial discipline.- MBA or Master's or… more
- Merck & Co. (Rahway, NJ)
- …, Process Improvements, Project Management, Project Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management, Regulatory ... and maintenance of customs valuation standards and procedures and to design and upgrade customs valuation related training materials.Provide trade and customs… more
- Merck & Co. (Rahway, NJ)
- …PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, quantitative systems ... and other submissions to global regulatory agencies. Skills in experimental design , mathematical problem solving, critical data analysis /interpretation, - and… more
- Merck & Co. (Rahway, NJ)
- …or T- cell engagers will be preferred Skills in experimental design , mathematical problem solving, critical data analysis /interpretation, and ... and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Director, Quantitative Systems Pharmacology (QSP) . QP2-IO team is part of the Global Clinical… more
- Merck & Co. (Rahway, NJ)
- …experience with applications of pharmacometrics methods. Skills in experimental design , mathematical problem solving, critical data analysis /interpretation, and ... exposure-response models, clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the organization complies fully with all regulations relevant to computerized systems design , build, and implementation.Ensure that the organization complies ... of IT services and determining audit targets for GxP systems .ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director, Data Quality and Integrity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. SummaryThe Business Architect Sales & Distribution Solutions is responsible for the analysis and design of business processes in this business area ... and is also responsible for the solution design and implementation. The role actively supports process management...modules integrate seamlessly with other SAP modules and third-party systems , by working closely with internal and external support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for providing engineering support for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. ... issues, deviations, corrections, remediation and improvement efforts of automation and controls systems for facility, equipment, systems and processes in support… more
- City of New York (New York, NY)
- …BE IMMEDIATELY REACHABLE ON EXAM NO. 1133 Under general supervision of the Director of Systems Analysis and Design , (Computer Systems Manager, NM-1), ... of independent initiative and judgment, the Computer Associate (Software) II, functions as Systems Design Analyst is responsible for the analysis design ,… more
