- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for ... a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory ... study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative or IST… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position As the Senior Director Supply Chain Operations and North America Demand Planning, you will ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi ... diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project...senior leadership at DP0. Surface expert knowledge on safety biomarkers that might be used in preclinical and… more
- Merck & Co. (Rahway, NJ)
- …diverse and inclusive work environment.Knowledge, Duties & Responsibilities for the Director Include:Oral drug product development concepts, tools, and ... and scaling up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP)… more
- Eisai, Inc (Nutley, NJ)
- …planning and supportive tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with ... area to provide strategic input for the development of product strategies and liaise with external stakeholders to solicit...Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders,… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and ... communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for ... a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to ... includes operations that support end-to-end GMP clinical supply manufacture and product /process development, as well as oversight of the Enterprise Resource Planning… more
- Merck & Co. (Rahway, NJ)
- …Sciences (RaDS) value team in Our Company's R&D IT brings together product management, engineering, and data science expertise to enable data and technology ... change the course of human health. In the RaDS value team, the Product organization is responsible for implementing technology products and associated services to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address recurring ... the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... the automation systems in compliance with cGMPs. The Manufacturing Automation Sr . Specialist must actively support, participate and embrace an empowered team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to epidemiology strategy for assigned products. Collaborate with epidemiology colleagues and Product Safety Lead to identify research gaps, develop protocols, ... peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize safety events for assigned product . Research natural history of… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality system functions, as needed. The Role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Director , QA Operations as part of the Quality team based in Raritan, NJ. Role ... Overview The Director of Quality Operations , CAR-T is responsible for...Disposition activities , including incoming materials and final drug product , QA shop floor oversight of manufacturing operations, Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... and escalating quality concerns. Relationships This position reports to the Associate Director of GXP Oversight and/or Head of GXP Support. Multiple internal… more
- AbbVie (North Chicago, IL)
- …communicate the safety profile of our drugs to protect patients worldwide. The Director , Product Safety Team Program Management plays a critical role in ... Description This position reports into the Office of the Product Safety Team (PST) department within the...creative ways to utilize limited resources and works with Sr . Director Office of the PST to… more
- BeiGene (San Mateo, CA)
- …Description:** The Senior Medical Director serves as the Product Safety Physician for complex strategically important developmental programs and creates ... depending on the program / portfolio being led. The Medical Director serves as Product Safety Physician for complex strategically important developmental… more
- J&J Family of Companies (Horsham, PA)
- …the product spokesperson regarding overall benefit/risk. The MSO will report to the GMS Sr . Director Product Safety Head, Oncology and oversee the ... will communicate potential and known risks and changes to benefit/risk, when appropriate, to the Sr . Director Product Safety Head, the VP Therapeutic… more
- Techtronic Industries North America, Inc. (Brookfield, WI)
- …company click HERE (https://www.milwaukeetool.com/Company/Milwaukee-Story) . Under the direction of the Director of Product Safety and Regulatory Compliance; ... is to assist in the coordination and execution of product safety related activities with a primary...+ Review and provide feedback for operator's manuals and on- product markings. + Assist the Department Director … more
