- Novo Nordisk Inc. (San Francisco, CA)
- …and community thought-leaders in an assigned territory. The Rare Renal Clinical Account Manager will be principally responsible for driving disease awareness, ... all types of healthcare practitioners, establishing the value proposition of rare renal drug in a compliant manner, maximizing sales and establishing NNI as a leader… more
- Merck & Co. (North Wales, PA)
- …required to have five years of safety experience or related areas such as Clinical Risk Management , Clinical or RegulatoryPreferred:Strong knowledge base of ... regulations.Ensure that PV activities are supported by robust procedures (eg, SOPs, User manuals, etc.).Promote understanding and education of PV regulation with all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external ... immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design,… more
- BioAgilytix (Durham, NC)
- …Deploy and configure VoIP phones and address phone related support requests Provide end user training in the use of Office 365 applications (ie Teams, OneDrive, ... never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain...Company's employees at all sites. The Specialist responds to end- user service requests in a timely manner; completes requests… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …level to ensure M&S area is a strategic partner in the projects and clinical drug development activities. This includes actively driving innovation and taking a ... broader and joint responsibility for clinical drug development across projects as well...current and future Medical and Science needs Ensure active use of performance management systems and individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labs or analysis labs in collaboration with relevant stakeholders including Data Management , Clinical Operations and QCP/CDx/ Clinical BiomarkersSupport ... knowledge of CLIA/CAP regulations and GLP guidelines preferredBasic knowledge of clinical trial design; understanding of the overall drug development… more
- Merck & Co. (Rahway, NJ)
- …scale-up, Drug Delivery and/or technology transfer experience including the use of gap analysis and risk assessment toolsHighly motivated, flexible, a change ... is responsible for the research and development of sterile & parenteral drug products for biologics including monoclonal antibodies (mAbs), di- & tri-specific… more
- Merck & Co. (North Wales, PA)
- …cycle (SDLC)Understanding of Statistical, Clinical , Medical Monitoring and Data Management concepts as applied to drug /vaccine development within the ... Description Position Summary Responsibilities :This position supports the centralized management of technology, platforms, inspections, and related process and… more
- BioAgilytix (Boston, MA)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... BioAgilytix Diagnostics is CLIA-certified, CAP-accredited, New York State licensed clinical diagnostic testing facility providing esoteric testing services to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non- ... nursing degree with 15+ years' experience in global safety surveillance and/or clinical / drug development Excellent verbal and written communication skills Strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …required- Prior experience in project management or leading change management initiatives preferred- Prior experience in clinical development, Medical ... preferred- Demonstrated success in planning and executing strategies for global drug development, commercialization, and life cycle management preferred- Strong… more
- Merck & Co. (North Wales, PA)
- …for analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly ... and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management , Clinical and other project stakeholders.-Primary ResponsibilitiesSupporting… more
- Merck & Co. (North Wales, PA)
- …human health. This position supports statistical programming activities for late stage drug /vaccine clinical development projects. This may include leadership of ... be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM… more
- Eisai, Inc (Nutley, NJ)
- …to use cutting edge modeling approaches to advance the clinical and translational research in Neuroscience. This individual will provide scientific leadership ... strategies in support of key decisions for programs across all phases of drug development. The complexity and scale of data being generated has grown significantly… more
- Merck & Co. (North Wales, PA)
- …supports statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the ... be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM… more
- The George Washington University (Washington, DC)
- …regulatory documents. 4. Tracks participants' adverse reactions examples include data management , clinical follow up. Assesses adverse reaction, discuss with ... research, innovative education, and equitable care for all. Job Summary: The Clinical Research Coordinator, CRC supports research projects in an assigned practice… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This ... Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP… more
- Aequor (Providence, RI)
- …support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data management . In this ... Additional responsibilities include business process support, such as SOP authoring and management , or gap assessments to regional regulations. Expertise in project … more
- The George Washington University (Washington, DC)
- …completing regulatory documents. Tracks participants' adverse reactions examples include data management , clinical follow up. Assesses adverse reaction, discuss ... groundbreaking research, innovative education, and equitable care for all.The Clinical Research Coordinator supports research projects in an assigned Practice… more
