- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordination, authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. ... and external stakeholders. Collaboration with external stakeholders (eg, research pharmacists, clinical study partner management ) may also be required.… more
- Merck & Co. (Rahway, NJ)
- …(Bulk Drug Product and Clinical Finished Goods).-- Responsible for authoring clinical supply documentation in support of labeling and packaging activities as ... documentation to support critical CMC activities.- Responsible for authoring the Clinical Supplies section of the study protocol as well as preparation and… more
- Merck & Co. (Rahway, NJ)
- …and program cost estimates requested by Product Development Teams.-Responsible for authoring clinical supply documentation in support of labeling and packaging ... as well as supply chain documentation to support critical CMC activities.-- Support the collection of clinical supply chain metrics and/or participate in… more
- Merck & Co. (Rahway, NJ)
- …and subsequent movement through our depot network and further through to distribution and management of materials to the clinical site. The incumbent must have ... robust and consolidated forecast for CFGs is maintained. Report clinical supply chain incidents to support the...Pharmaceutical Clinical Supply (packaging, labeling, logistics and clinical supply inventory management ) At least 5… more
- Merck & Co. (Rahway, NJ)
- …Research and Development Division's IT) to serve company patients.The Sr. Specialist, Global Clinical Supply Compliance is a support role for the GCS functional ... with quality products? Within our Research and Development Division, the Global Clinical Supply (GCS) organization is accountable for the end-to-end supply chain… more
- Merck & Co. (Rahway, NJ)
- …and/or PhD whose primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval ... position requires the candidate be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies.The… more
- Eisai, Inc (Nutley, NJ)
- …licensing agreements. May also audit operating systems, processes and procedures. May support risk management operations, including ongoing review of literature ... working onsite in our Nutley, NJ office. Responsibilities Proactively provide GCP QA support for clinical development activities to protect patient safety &… more
- Eisai, Inc (Nutley, NJ)
- …as applicableReview regulatory packet for investigational product releaseProvide user access management support ; tracking certifications and maintain statuses ... patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that...is your profile, we want to hear from you.The Clinical Trial Assistant will support all phases… more
- Legend Biotech USA, Inc. (Minneapolis, MN)
- …to both clinical and behavioral aspects of treatment and disease management .The Sr. CTCE will serve as the strategic education leader across oncology accounts ... Legend Biotech is seeking a Sr. Cell Therapy Clinical Educator, Midwest as part of the Commercial...on PI-based and disease state education to non-physician patient care teams (PCTs), including nurses, nurse navigators, pharmacists, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primary source of medical accountability and oversight for one or more clinical trialsMatrix management responsibilities across the internal and external ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Genmab (NJ)
- … the implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of ... and drive innovative solutions to meet the needs of our patients, care partners, families and employees.Our people are compassionate, candid, and purposeful, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking ... plan.Distribute key study documents to the CRO and vendors as appropriate.Provide clinical administrative support to the study teams. This may include… more
- Novo Nordisk Inc. (Fort Smith, AR)
- …relationships with those individuals Recognize opportunities to productively challenge HCPs clinical management of patients that respects their knowledge and ... and the implications and importance of generating advocacy and support for them Partner with the Novo Nordisk Sales/Marketing...care models, protocols, etc. to engage HCPs in clinical conversations to appreciate how they manage patients with… more
- Novo Nordisk Inc. (Valdosta, GA)
- …to gain access and drive business impact by collaborating around the clinical management of patients and offering NNI-approved solutions Demonstrates ... Novo Nordisk, we are the world leader in diabetes care and a major player in defeating other serious...discretionary territory budget and marketing promotional program budget to support territory sales goals Demonstrates a clear and thorough… more
- Novo Nordisk Inc. (Denver, CO)
- …and insights with target physicians Recognizes opportunities to productively challenge HCPs clinical management of patients that respects their knowledge and ... guidelines, chronic care models, protocols, etc. to engage HCPs in clinical conversations to appreciate how they manage patients with diabetes and where they… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... concurrently are crucial for this role. Advanced knowledge of Data Management , Biostatistics, Clinical Operations, Pharmacovigilance, handling and processing of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Establishes company-wide laboratory data management strategies and processes in support of clinical development objectives.- Accountable for lab data ... Lab Technology (MLACS-accredited), or NAACLS-accredited preferred Experience Qualifications - Clinical data management laboratory experience and strong knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of the global data ... within the function and cross-functionally to resolve issues pertaining to data management in clinical trials and submissions work.Proactively identifies and… more
- Novo Nordisk Inc. (Boston, MA)
- …other stakeholders in a given geography. Utilizing approved clinical resources to support provider efforts to deliver appropriate care for patients. Our goal ... chronic disease often requiring pharmacotherapy o Use Standards of Care for Obesity Management to educate HCPs...elevated CV risks associated with type 2 diabetes o Support branded messaging when appropriate Clinical Addendum… more
