- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for ... Degree preferredExperience Qualifications7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or… more
- Merck & Co. (Rahway, NJ)
- …successful tech transfer packages, filing and approval, and a robust commercial supply chain to-achieve launch on time and uninterrupted long-term supply ... across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality, and Supply Chain from early development through to commercial manufacturing.- Deep… more
- Merck & Co. (Rahway, NJ)
- …scientists, provide oversight to multiple programs, operate at the interface of clinical supply and commercialization, and broaden their experience in Biologics ... external capabilities and capacity are available to assure continuity of clinical supply and support registration targets.Ensure high quality documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... perform safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …business processes and effective reporting systems to support reliable commercial and clinical supply . It also involves leading communication and collaboration ... principles, processes, technologies, and talent management.Key Responsibilities Develop and lead an effective manufacturing and supply organization, supporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...are likely to benefit from our therapeutics.Contributes to CDx project teams for the diagnostic, under the direction of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or ... new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project Team (OPT) leader; Responsible before the IST for the creation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manage a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to ... Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of...Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical studies. ... Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of...always maintained and accurate. Accountable to the Global Team Lead (GTL) and GPT (Global Project Team)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... direction and long-term vision for the Company. The position will also lead the Medical Affairs organization which is responsible for providing impactful medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... interactions with cross-functional team members and leads complex discussions at the project team level as well as at governance meetings. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.Key ResponsibilitiesThis individual ... within the facility to ensure high quality and compliant product supply and oversee production metrics. This individual will support manufacturing investigations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with cross-functional teams, including therapy area marketing, market access (MAPA) and clinical / medical (CMR) teams to ensure alignment of lifecycle management ... pricing strategies, and lifecycle management tactics Lifecycle Management Strategy: Lead the development of comprehensive lifecycle management plans for each… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for ... Supply Plans in close communication with CSO project Management Lead + Responsible for the...+ 7 or More Years of related experience, including Project Management, Clinical Supply Management,… more
