- Merck & Co. (Rahway, NJ)
- …quality data and clinical supplies. This position reports to the Associate Director of Global Clinical Supplies Quality and is critical to maintaining ... and quality improvements.Assists in the coordination of significant quality events including fact-finding, investigation, coordination of clinical quarantine… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity to work in a ... growing Clinical Operations Department that manages multiple early to late-stage clinical programs. The Associate Director role will be responsible for all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …seeks to improve working procedures, quality , and output. The Strategy Director serves as the clinical development strategy lead for pipeline projects. ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....needed. Relationships This position reports directly to the Executive Director , Clinical Development Strategy (CDS) and will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of ... and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical ... CDP planning and individual protocols to facilitate successful implementation of programs. Clinical Operations:Ensure high quality delivery of all studies for… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global ... at the forefront of bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work in partnership with several… more
- Merck & Co. (Rahway, NJ)
- …role involves close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs ... Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting… more
- Genmab (NJ)
- …effective planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight to ... best, and authentic is essential to fulfilling our purpose.The Role:An Associate Director , Data Management is operationally responsible for the oversight of … 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Insmed Incorporated (San Diego, CA)
- … development strategy and clinical protocols and delivering high quality clinical programs, from first-in-human trials, through to full development.Serve ... of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality , and biostatistics.Provide medical leadership for key… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Director of Medical Device and Combination Product Quality Assurance, the Associate Director Quality Engineering & ... 14971) and other worldwide regulations and requirements. This position provides Device quality engineering, quality assurance support and leadership to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... find better and more innovative ways to improve their quality of life. We're changing lives for a living.... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing ... various GMP activities supporting the production of clinical supplies with focus on drug product. The position...be heavily involved in close collaboration with the contractor quality and technical personnel and will partner with internal… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- clinical , Medical Affairs, Marketing, Legal, Quality , and other ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- clinical , Medical Affairs, Marketing, Legal, Quality , and other ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Genmab (Plainsboro, NJ)
- …and dedicated Medical Director to be a part of our Global Clinical Development Team.The Medical Director will be accountable for the medical oversight ... to preclinical development of candidate therapeutic antibodies. Drive and monitor quality of all clinical documents (eg, Investigators' Brochures, protocols,… more
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