- Novo Nordisk Inc. (Plainsboro, NJ)
- …the global regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead health authority interactions, ... merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of...including leading team through creation of briefing materials and meeting preparation Lead and/or support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to experiment with us? The Position The Brand (Sema AD) HCP Experience Lead will play a critical role in ensuring helping ensure the successful execution of ... omnichannel execution. Relationships Reports to the Brand (Sema) Alzheimer's Disease Lead . Responsible for providing interface with key internal and external… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... generation plans based on insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... Market development, as well as Global Medical Affairs. Essential Functions Lead projects, representing Medical Affairs interests on cross-functional teams including,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Lead Operations Gowning Trainer as part of the Technical Operations team based in ... projects for the Gown Training Program. This position is responsible for quality and maintaining the highest standards in compliance within company policies,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to...documents and communications, and conducting a final review of materials prior to OLT submission. This position acts as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before ... Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major scientific/medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before ... Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities:Study Strategy: Clinical study leader (CSL) or major scientific/medical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the Global Manufacturing & Supply (GMS) data governance process, from material creation to consumption across Warehouse, Materials Planning, Work Centers, ... Bill of Materials / Recipes, Costing and Quality Inspection attributes. This role will partner with the...process owners to conduct comprehensive analysis on all GMS material management aspects addressing data creation, data quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs ... Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population...interactions at FIHC, WDC; Initiates contact w/KOL and prepares material for KOL interactions on a program based need;… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …develop an effective Warehouse Operations team responsible for all inbound, outbound, material receipt & inventory management, and distribution processes for raw ... materials and final drug products.Establish a strong relationship between...environment.Support the treatment and on time closure of deviations, Quality investigations and CAPA's related to operational activities.Ensure good… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …development of investigations and root cause analyses on any supply disruptions or material quality related issues.Support Quality , Regulatory and Financial ... performance.Key Responsibilities Interpret and analyze demand and usage of various materials including (but not limited to) critical supplies, clinical materials… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …primarily serving the US market. The scope includes everything from raw material procurement to Drug Product release and patient shipment. Additionally, the role ... principles, processes, technologies, and talent management.Key Responsibilities Develop and lead an effective manufacturing and supply organization, supporting teams… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cleaners to ensure the facility meets aseptic requirements for Manufacturing and Quality Control Labs. This person will communicate and provide updates 1st shift ... cleaners are compliant with the training and general manufacturing practices.Key Responsibilities Lead the 3rd shift cleaning team to ensure facility readiness for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure that shared point data is current and accurate- In collaboration with the Lead Global QA Strategy and Operations (RDPVMA QA), Collate and produce accurate and ... teams for awareness.- Creates and proofs packets of information; develops documents and materials for meetings and a wide array of audiences- Edits and produces… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …list of congresses that would best support the company and brand objectives.- Lead planning and execution weekly meetings with Global and/or National Congresses key ... corporate awareness.- Drive collaboration and partnerships between DS Regional Congress lead (DSE, DBR ) to align on expectations, ensure global participation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …execution of daily activities related to calibration and instrumentationEnsures proper materials , tools, standards, parts and spare parts are identified and ... programsAssists in the creation, tracking and completion of metrology related SOPs, quality events, CAPAs, Out of Tolerance (OOT) situations and other technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and corrective, preventative and predictive maintenance, and repairEnsures proper materials , parts and spare parts are identified and availablePerforms work ... programsAssists in the creation, tracking and completion of maintenance related quality events, CAPAs, and Out of Tolerance (OOT) situationsConducts basic risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position will lead the valuation processes for in-licensing, out-licensing, co-development and/or acquiring ... involve working cross-functionally to gather relevant information, synthesize the materials , and develop comprehensive opportunity assessments consistent with our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …environmentKey Responsibilities Support process changes arising from updates to materials , excipients or finished goods requirements.Support efforts to establish and ... data analysis to support establishment and monitoring of change control for operations. Lead cross functional team meetings to prioritize updates to MBRs/ EBR/MES… more
