- Novo Nordisk Inc. (WA)
- …strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …setting required A minimum of 2 years of direct expertise of site management and logistical execution of clinical trials required Relevant Novo Nordisk ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (Rahway, NJ)
- …oversight of, contractors performing various GMP activities supporting the production of clinical supplies with focus on drug product . Additionally, experience ... and develop a strong working relationship with commercial external quality management personnel.- The incumbents would be the key quality representatives attending… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... 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… more
- Merck & Co. (North Wales, PA)
- …(CSS) group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our Research and ... position:Serve as a statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support for related drug/vaccine… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product , or New Modality) Lead ... is responsible for the management of technology transfer of the manufacturing processes of...of the manufacturing processes of (mAb, Drug Substance, Drug Product , or New Modality) for investigational and commercial drugs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … across internal and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function of the CMR ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (North Wales, PA)
- …systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine ... collaborate to discover the next medical breakthrough.Position Description: The Associate Principal Scientist Statistical Programming leads the statistical programming… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …placement and delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply ... Operations (shipping, receiving, inventory control, customs clearance, supply / device management ) Responsible to ensure timely availability of clinical study… more
- Merck & Co. (Rahway, NJ)
- …our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- ... Job DescriptionAssociate Technician, OperationsPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...to Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic ... of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries out… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and ... functions including but not limited to Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs.Responsibilities- Lead the development of… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing ... need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential?… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Associate OpEx Engineer as part of the Technical Operations team based in Raritan, ... for providing operational excellence continuous improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead… more
- Merck & Co. (Rahway, NJ)
- …capabilities that allow for better access to high-fidelity data, more efficient clinical product release, improved product /process characterization, and more ... Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing...is based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...Manager will be responsible for facilitating the creation and management of financial budgets and resource strategies for a… more
