- Daiichi Sankyo, Inc. (Bernards, NJ)
- …representation in audits and regulatory inspections to provide relevant programming and reporting information as needed. Provides input for DM questions in ... and external stakeholders to oversee the development and delivery of clinical data programming, reporting , data visualizations, external data acquisition… more
- Insmed Incorporated (NJ)
- …to ensure the effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting . Represents ... indications within one compound, in collaboration with the Senior Director, Clinical Operations. Ensures consistent and successful execution of operational aspects… more
- Insmed Incorporated (NJ)
- …expand what's possible for patients with serious diseases. In this role, you'll be reporting to the Sr. Manager, Clinical Supply Chain & Logistics.The Insmed ... About the Role:We're looking for a Summer Intern - Clinical Supply Chain & Logistics on the Logistics to...know the nature of your request and your contact information . Requests for accommodation will be considered on a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with all Federal regulations, guidance, and company SOPs regarding adverse event reporting from post-marketing sources and clinical trials complaint handling ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...review and vendor management support in regard to safety reporting . To serves as a liaison between NNI Patient… more
- Merck & Co. (North Wales, PA)
- …regarding vaccine safety and efficacy, as well as analysis, interpretation, and reporting of final clinical trial results.In addition to responsibilities ... Job DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries...for protected veterans and individuals with disabilities.- For more information about personal rights under the US Equal Opportunity… more
- Merck & Co. (Upper Gwynedd, PA)
- …Work, Clinical Development, Clinical Documentation, Clinical Judgment, Clinical Medicine, Clinical Reporting , Clinical Research Management, ... --The Senior Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of a supervisor, the Senior Director has… more
- Merck & Co. (Boston, MA)
- …Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the ... area. Our company's Atherosclerosis & Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and… 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 ... The Position The position serves as the lead of Clinical Data Science & Evidence (CDSE) operations. In their...of strategic importance and be responsible for communicating relevant information within CDSE and to internal stakeholders. Their duties… more
- Merck & Co. (Rahway, NJ)
- …with CROs to develop and analytically validate genetic biomarker assays to support clinical programs. Oversee and/or support results reporting and analysis of ... Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers into clinical development across all therapeutic areas and all phases of … more
- Genmab (NJ)
- …Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data ... standards and other industry standards that supports the exchange of data, reporting , and analysis. Ensures alignment of SDTM standards with data collection… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Associate Director, Clinical Research Scientist will support and work predominately with the Medical Monitor ... and cross functional teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as well… more
- Eisai, Inc (Pittsburgh, PA)
- …Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products; provide a conduit for communication between ... and its hhc mission; b) provide key scientific and clinical information about Eisai's products; serve as...to lead and motivate team members without a direct reporting relationship.Ability and interest in leading and participating in… more
- Merck & Co. (Rahway, NJ)
- …programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and ... execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables,...listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post… more
- Merck & Co. (Rahway, NJ)
- …for approval of drug/vaccine products; Prior experiences with immunology clinical trials design, analysis and reporting strongly ... management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials.- The knowledge must be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance ... with Global PV regulations for individual case safety and periodic reporting . Serves as the key DSI contact for PV service providers to address, escalate issues… more
- Merck & Co. (Rahway, NJ)
- …analytics, and stewarding these data, you will empower our scientists and clinical teams to make faster, data-driven decisions that propel our pipeline forward.In ... comprehensive specimen inventory by tracking specimens collected from our company clinical trials and assay metadata generated from these collections.Embed automated… more
- Merck & Co. (North Wales, PA)
- …health. This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early and late Development PK/PD ... departmental SOPs and collaborate effectively with stakeholders (Statistician, modelers, clinical team), other functional areas and outsource partners. Primary… more
- Insmed Incorporated (NJ)
- …of Programming strategies and efficient execution of analyses for assigned clinical projects. Collaborates with cross-functional team members within Biometrics, ... Clinical Operations, Regulatory, and Clinical Development, as...Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate… more
- Merck & Co. (Lower Gwynedd, PA)
- …join a multidisciplinary team partnering with lab scientists, automation engineers, IT, Clinical , and QA, to turn operational and scientific data into trusted ... IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data.… more
