- Merck & Co. (Rahway, NJ)
- …drug products.Our team is looking for a candidate for the position of Associate Principal Scientist (R4) supporting the Biologics formulation team within Sterile and ... duties:Lead/ contribute towards the new, innovative approaches for biologics sterile product development through the generation of experimental designs, execution of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director, Program Management is a senior position responsible for effectively ... risks as well as achieving overall project level quality metrics. An ideal Associate Director, Program Management must have the expertise and leadership to manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …most specifically with all customer facing teams to monitor the success of product messaging, programs and promotional effort. The Associate Director is also ... other research areas centered around rare diseases and immune disorders. SummaryThe Associate Director, Consumer Marketing serves as the patient, brand and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary: The Associate Director, Regional Marketing Conventions & Field Programs will be ... Marketing leadership to oversee and execute all aspects of field-based programs, product theaters, & national broadcasts in conjunction with the Brand teams. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC ... Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation… more
- Merck & Co. (Rahway, NJ)
- …(FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This ... the FLEx Center in Rahway is looking for an Associate Specialist - Process Engineer to lead clinical supply...batch records and MES systems.Knowledge and experience of drug product processing.Desire and willingness to learn and contribute through… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to ... or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Lead the definition of solutions ... with the business users to define user information needs, research innovative product value proposition and collect ideas for future roadmaps and planned projects;… more
- Merck & Co. (Rahway, NJ)
- …providing expertise in SAP landscape technologies including cloud infrastructure providers, SAP product roadmaps, SAP cloud solutions & integrations, as well as SAP ... landscape design, implementation, and support. You will help ensure stability of our SAP ecosystem through resilient design, high availability, performance monitoring, and secure access to SAP systems, databases, and related technologies. This critical role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget. ... Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …providing forecasting & financial support to Brand Teams by assisting product directors/ managers with strategic planning and financial consulting, leading financial ... planning and net revenue forecasting processes.The person will own and facilitate the forecasting process to develop P&L projections for the inline and pipeline brands, partner with various functional groups to provide financial assessment, communicate results… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Required to keep informed of industry trends and newsworthy happenings, company product pipeline progress, and overall financial position of the Company in order ... to provide meaningful support and input into the Outsourcing strategies and their implementation plans of their specific strategies.- Develops innovative sourcing methods- Demonstrates expert understanding of procurement principles, legal language, vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned project(s).Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting ... breakthrough therapy designation requests, orphan drug applications.Participate in global product team meetings (development and marketed products); provide regulatory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Device Development Associate Principal Scientist - Development Strategy, Design Controls and Risk Management Our company's ... will be responsible for leading and implementing medical device and combination product design controls and risk management activities for both new products and… more
- Merck & Co. (Rahway, NJ)
- …to lead project management efforts to support Chemistry Manufacturing & Controls (CMC) product development from First in Human to Transfer to Supply, driving line of ... lifecycle and maintaining programs in harmony with the portfolio. In addition, the Associate Director will be expected to participate in development of tools and… more
- Merck & Co. (Rahway, NJ)
- …and approaches.-Responsibilities include assay development, representing the group on product development teams and supporting defining the potency strategy for ... interpretation of potency data in context of broader process and product development.-Working knowledge of regulatory guidance and quality standards, with experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget. ... Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.Global… more
- Merck & Co. (Rahway, NJ)
- …vaccines for the benefit of patients and global human health. The Associate Principal Scientist, Clinical Trial Analysis and Reporting leads the statistical ... statistical programming point of contact and knowledge holder through the entire product lifecycle.Key areas of focus include (1) the assurance of deliverable… more
- Merck & Co. (Rahway, NJ)
- …described in the Pipeline Advertisement.As a strategic marketing position, the Associate Director will provide recommendations that will contribute to shaping the ... execution of tactics, performance tracking, motivated planning, and accountability for product growth.- Strong analytical skills and the ability to synthesize key… more
