- Formation Bio (New York, NY)
- …timelines, and support decision-making in biologics development and manufacturing. Project Management Own CMC timelines, budgets, and resources across biologics ... documents; comfort engaging with regulatory authorities. Familiarity with Quality by Design (QbD) principles and their application in CMC development. Demonstrated… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Senior Scientist, Device Design Control Lead, is a crucial member of our team, responsible for spearheading design control ... commercialization, and lifecycle management. This individual will oversee device design control activities to ensure the delivery of high-quality products… more
- Aequor (New Brunswick, NJ)
- Position: PROJ MGT - Project Manager-Business Capability Duration: 6 Months Location: Candidates must work 50% onsite at New Brunswick. Local candidates highly ... Must - 3 years minimum Must have IT SDLC Project Management experience (especially with exposure to SAP ...translating BRD into URS, FRS, and Technical Specs, obtain design ✅ Support functional leads in validation testing documentation,… more
- Eisai, Inc (Nutley, NJ)
- …The position is intended to provide the organization with a qualified individual to design and oversee the conduct of clinical studies for Phase 2 and 3 development ... Responsibilities: Provide scientific support for clinical development planning, study design /execution, and data monitoring to ensure successful implementation of… more
- Merck & Co. (Rahway, NJ)
- …field, priorities and portfolio needsMaintains continuity of technical knowledge, study design , and analysis strategies across various project teams, fostering ... design and analysis methodologies where appropriate to advance project goals.Drives people development and talent management initiatives, fostering a culture… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist is a DVM/VMD and/or PhD whose primary function is to design , coordinate, monitor, and report clinical laboratory and field studies that will ... Principal Scientist can also be responsible for several effectiveness studies within a project , participating as the clinical representative in project teams as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... focus on DFM/DFA principles.Understanding of autoinjector/parenteral/pre-filled syringe delivery device design and function, and the ability to develop robust… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDUTIES:Responsible for complex workstreams and implement capital project scope and technical studies that support business objectives, with focus on ... Process Design and Process Safety for Small Molecule High Potency/Containment...Process Safety for Small Molecule High Potency/Containment Projects. Develop project scope, front-end planning, and provide innovative designs and… more
- Merck & Co. (Rahway, NJ)
- …to the Region. This includes continual optimization of the organizational - design and resources, ownership and optimization of key processes, talent and succession ... in site management and selection decisions. Provide input into protocol - design , feasibility, and resource assessments as appropriate. Support the development and… more
- Merck & Co. (Rahway, NJ)
- …safe, effective, innovative medicine. -The Early Clinical Scientist/ECS coordinates the design , planning and execution of early phase clinical trials with the ... study objectives and data validity. Manages internal/external team performance to achieve project objectives and resolves project performance issues if they… more
- Merck & Co. (Rahway, NJ)
- …submissions and post marketing support.The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups ... position is a key collaborator with statistics and other project stakeholders in ensuring that project plans...thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind… more
- Eisai, Inc (Nutley, NJ)
- …Market Access, Eisai Patient Support, and our Specialty Pharmacy partners in the design and delivery of this solution.Partner in the ongoing monitoring of current ... internal business partners and external agenciesActively participate in cross-functional project teams involving Marketing, Sales, Managed Markets/Market Access, Legal,… more
- Merck & Co. (Rahway, NJ)
- …supplier caused deviations and CAPAs.Integrate Purchasing Control Activities into Integrated Project Plan for each MDCP Program (with target dates) for ... identifying gaps in the QMS documents.Working knowledge for the design , manufacture, packaging, purchasing, testing, release, storage, and distribution of… more
- Merck & Co. (Rahway, NJ)
- …capital project team, knowledgeable of the Sterile Standards and equipment design standards, and understanding of project / engineering work process and ... safety, efficacy, and delivery. -During development, we leverage smart experimental design , cutting edge analytical tools, and predictive approaches to inform… more
- Merck & Co. (Rahway, NJ)
- …immensely creative and collaborative team of scientists and engineers to design purification processes while develop ing technical strategies related to downstream ... strategic initiatives; partner with senior leaders to set overall project strategy, and guide teams towards its executio n...- Expertise in independent ly conducting and directing the design , execution, analysis, and documentation of all stages of… more
- Merck & Co. (Rahway, NJ)
- …manage the entire cycle of clinical development, including study design , initiation, execution,- monitoring, analysis, regulatory reporting, publication, and ... requirements, the competitive landscape, and commercial considerations;Planning clinical trials ( design , operational plans, settings) based on these clinical development… more
- Merck & Co. (Rahway, NJ)
- …manage the entire cycle of clinical development, including study design , placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the ... strategies for investigational or marketed Oncology drugsPlanning clinical trials ( design , operational plans, settings) based on these clinical development… more
- Merck & Co. (Rahway, NJ)
- …manage the entire cycle of clinical development, including study design , placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The ... strategies for investigational or marketed Oncology drugsPlanning clinical trials ( design , operational plans, settings) based on these clinical development… more
- Eisai, Inc (Nutley, NJ)
- …inform planning and predict market actions.Advance the organizational capability in design , development, and implementation of modern data analytic applications and ... to identify meaningful audience segments. Experience with leading projects or project teams. Considerable experience in solving business problems with advanced… more
- Merck & Co. (Rahway, NJ)
- …clinical development and studies, including development strategy, study design , initiation, execution, monitoring, analysis, regulatory reporting, and ... strategies for investigational or marketed Atherosclerosis drugsPlanning clinical trials ( design , operational plans, settings) based on these clinical development… more
