- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Metrology Specialist as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with… more
- Eisai, Inc (San Diego, CA)
- …customer business, disease state, product prescribing information, approved promotional clinical trials, patient access to medication, and regulatory /compliance ... want to hear from you. Job Summary The Sr. Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology therapeutic products… more
- Eisai, Inc (Sacramento, CA)
- … Specialist (Sr NAS) Responsibilities Develop and maintain superior clinical expertise with our brand(s) and disease state/conditions to effectively educate ... Alzheimer's disease (AD) or mild AD. TheSenior Neurology Account Specialist (Sr NAS) will be part of a diverse...the primary role of demand generation by conveying complex clinical information to customers and key stakeholders consistent with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role ... OverviewThe QA Shop Floor Specialist is an exempt level position responsible for the...oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP… more
- Eisai, Inc (Fort Worth, TX)
- …customer business, disease state, product prescribing information, approved promotional clinical trials, patient access to medication, and regulatory /compliance ... want to hear from you. Job Summary The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology therapeutic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma.Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Warehouse Incoming/Raw Material Specialist is an exempt level position with responsibility to...materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Maintenance Specialist as part of the Technical Operations team based in Raritan, New ... be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift. This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Warehouse Specialist as part of the Technical Operations team based in Raritan. Role ... OverviewThe Warehouse Specialist will be part of the Technical Operations team...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Operations Inventory Control Specialist as part of the Technical Operations team based in Raritan, New ... Jersey. Role OverviewThe Operations Inventory Control Specialist will be part of the Raritan CAR-T Operations team responsible for building operations activity area… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Portfolio Operations Specialist will play a pivotal role in overseeing the Novo Nordisk's product portfolio ... with cross-functional teams, including therapy area marketing, market access (MAPA) and clinical / medical (CMR) teams to ensure alignment of lifecycle management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Technical Equipment Specialist as part of the Technical Operations team based in Raritan, NJ. Role ... OverviewThe Technical Equipment Specialist will be responsible for ensuring equipment/systems required to...of the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as facility expansions… more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills: Knowledge of Investigational drug regulatory requirementsAudit experience: safety, environmental, compliance/qualityUnderstanding of ... is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of ... global function on study and project teams.Produces independent writing for publications and regulatory documents.Serves as a specialist in PK-PD and Pop PK-PD… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Reviews and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections Other duties as assigned Performs all job duties and ... biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and ... study and project teamsProduces independent writing for publications & regulatory documentsServes as a specialist in PK-PD... in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and… more
- Hinge-Health (San Francisco, CA)
- About the RoleIn this role as a Regulatory Affairs Specialist , you will have responsibility for developing and influencing regulatory policy and determining ... pursuing courses of action necessary to obtain and expand regulatory approval of Hinge Health's medical device portfolio. This... approval of Hinge Health's medical device portfolio. This Specialist will work with internal and 3rd party experts… more
- Karl Storz Endoscopy (El Segundo, CA)
- …disease and patient societies etc.). The Medical Director will also lead our Communications Specialist and work closely with our Clinical Affairs team to obtain ... guidance to teams working across the lifecycle of KARL STORZ products.Provide clinical use scenarios for development and regulatory teams.Provide integrated… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to accelerate and expand that transformation. At Legend Biotech, we are excited to bring clinical trials to patients in our pursuit of a cure. While we are focused ... OverviewThe QC Technician is responsible for QC sample labelling process. The QC Specialist is encouraged to work independently on routine tasks and have conceptual… more
- Merck & Co. (North Wales, PA)
- …includes integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory , market access, manufacturing, CMC, commercial, and other ... to the information that they need.Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common projects.… more
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