- Merck & Co. (Rahway, NJ)
- …auto-injectors, on-body infusers/injectors, inhalers, and more. As a subject matter expert in medical device and combination product design verification, ... product we develop. We are seeking individuals with expertise in design verification & characterization testing for the development and commercialization of… more
- Tris Pharma (Monmouth Junction, NJ)
- …other member of Senior Leadership, she/he serves as a Subject Matter Expert (SME) regarding Pain specific clinical development and provides strategic guidance for ... Pain clinical programs to ensure clinical activities utilize cutting-edge trial design . The incumbent also provides insights and assists, as needed, in the pipeline… more
- Novo Nordisk Inc. (Boulder, CO)
- …production, including template dependent and independent methods Be a subject matter expert in the use of enzyme classes relevant to biocatalytic methods of ... that focus on the sustainable manufacturing of oligonucleotides Contribute to the design of laboratory space for expansion of research capabilities into enzymology… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Manages mutually beneficial relationships with external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACD ... relationships positively with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement/innovation projects for NACO… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …End-to-End Manufacturing & Supply lifecycle. This role is pivotal in leading the design and execution of the Global Manufacturing & Supply (GMS) data governance ... This role will partner with the IT team and collaborate in the design -implementation of Legend's Master Data Management program. We are looking for a well-organized… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …complex problems Excellent interpersonal, negotiation, written and oral communication skills Expert knowledge of systems analysis and design techniques Knowledge ... well as external suppliers and partners. Essential Functions Lead evaluation, design , and analysis of enterprise-wide solutions Translate business and technical… more
- Eisai, Inc (Nutley, NJ)
- …for products in the therapeutic area. The Medical Director utilizes expert medical/scientific knowledge in assigned therapeutic area to provide strategic input ... and inform stakeholders of progress.Phase IV Clinical Studies: Direct and design strategies, planning and implementation of Phase IV clinical development programs… more
- Eisai, Inc (Nutley, NJ)
- …for products in the therapeutic area. The Medical Director will utilize expert medical/scientific knowledge in assigned therapeutic area to provide strategic input ... inform stakeholders of progress. 30%Phase IV clinical studies: Direct and design strategies, planning and implementation of Phase IV clinical development programs… more
- Merck & Co. (Rahway, NJ)
- …safety, efficacy, and delivery. During development, we leverage smart experimental design , cutting edge analytical tools, and predictive approaches to inform ... fusion proteins, combinations such as doublet or triplet co-formulationsSubject matter expert of process development and process characterization for biologic drug… more
- Eisai, Inc (Nutley, NJ)
- …insights into clinical development plans, review and contribute to study design and define study endpoints.Draft statistical analysis plans, ensure the ... appropriateness and accuracy of study design and analyses, and validate that study results and...to ensure the successful delivery of data and programming requirements. Expert -level of knowledge of biostatistics, as evidenced by independence… more
- Merck & Co. (Rahway, NJ)
- …understanding of the strategic elements of drug development. As a subject matter expert , the Director within the QP2-IO Group will work closely with teams of ... and decisions of drug development teams. Primary Responsibilities: Serving as an expert representative for QP2 -IO on Oncology development teams. Framing critical… more
- Merck & Co. (Boston, MA)
- …PDMB efforts as a project-team representative and PK/PD subject matter expert , regularly interacting with multi-disciplinary discovery teams and partners from other ... your primary roles will include:Project-team representative and subject matter expert on protein therapeutic-based PDMB activities including generation and… more
- Merck & Co. (Rahway, NJ)
- …methods, tools, and techniques.Analyze market and/or user research, feedback, expert opinion, and usage data to understand needs and opportunities.Prioritize ... to define project scope and objectives, develop preliminary project plan and design .Manage and track product development work, especially when the work spans… more
- Merck & Co. (Durham, NC)
- …is given to issues as they ariseServe as a Subject Matter Expert during tours to provide area/process overview information to visitors/auditors upon request ... supply.Manage adherence to departmental maintenance metrics; ensures adherence to design standards and downtime tracking.Resolve and escalate issues impacting supply… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design . In addition, he/she will develop a QSP strategy to ... sub-modules for incorporation into systems (disease) modelsContribute to the design , execution and interpretation of clinical and non-clinical studies.Partner with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and evaluate business requirements and consult with stakeholders to ensure model design reflects business needs Maintain, develop, design and deploy ... affect or can be used in our current Models Act as a subject matter expert (SME) for Anaplan to the organization as well as championing best practices in Anaplan… more
- Merck & Co. (Rahway, NJ)
- …and execution for key stakeholders and will provide direction for the design and refinement of intelligence plans. The individual will perform these functions ... of key stakeholders (eg, surveillance, competitive planning, etc.) Support the design and execution of competitive planning initiatives (eg, competitive simulations)… more
- Merck & Co. (Rahway, NJ)
- …immensely creative and collaborative team of scientists and engineers to design upstream, cell-culture processes while developing technical strategies related to ... (peer-reviewed journals) and patentRepresent BPR&D as an upstream, cell-culture expert in internal, cross-functional project teams and external conferences/consortia… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Position leads very complex studies or entire drug project in study design , data analysis and interpretation of results independently with minimal supervision. This ... complex studies or an entire project. Act as statistical expert in the assigned projects. Guides the project team...team in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the… more
- Merck & Co. (Rahway, NJ)
- …of appropriate disease indications to pursue and subsequent study design , initiation, execution, monitoring, analysis, regulatory filing, and publication. ... development strategies for investigational drugs and planning clinical trials ( design , operational plans, settings) based on these clinical development… more
