- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... (iii) supporting consistency, coherence, and compliance, (iv) establishing area-relevant standards , (v) encouraging innovation.Build strong relationships with clinical… more
- Eisai, Inc (Nutley, NJ)
- …responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient ... understanding of statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other therapeutic areas as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …( Clinical Operations, Clinical Biomarkers, Precision Medicine, etc.) for establishing data collection, data standards and data cleaning needs ... to external data acquisition, and establishes external data standards , reinforces adherence to existing ...standard data collection practices preferred- 7+ years Clinical data management experience in a medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Merck & Co. (Rahway, NJ)
- …pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a ... processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Merck & Co. (North Wales, PA)
- …least 2 years of experience in publication managementUnderstanding of the clinical development process andclinical study data for assigned ... clinical development strategyThorough understanding of industry and publications standards about authorship, industry publications best practice, quality and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs...as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …processes/SOPs Cross-ta collaboration: Responsible for implementation of best practices and standards for clinical operations, including sharing lessons learned. ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Management by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards . Additionally, this position ... successful outcomes for projects/studies.This position has strong knowledge of Electronic Data Capture/related applications and industry standards , and strong… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... as other research areas centered around rare diseases and immune disorders.SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the Quantitative … more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical safety team, reporting ... to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this...represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author… more
- Merck & Co. (Rahway, NJ)
- …strategies for data organization, integration, and retrieval.Define and implement data standards , taxonomies, and ontologies to ensure consistent and ... biopharma research, such as public Omics databases (eg, GenBank, GEO), clinical trial repositories (eg, ClinicalTrials.gov), patient-level data platforms (eg,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Reviews documents and responses submitted to health authorities globally with respect to data standards , compliance, etc. May represents the function at health ... with standard procedures and processes. Leads the development and refinement of analysis data standards for AML as well as solid tumor studies.- Leadership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pharmaceutical aggregate spend solutions and data associated with promotional and clinical data , preferred. Ability to manage multiple projects to completion ... team in the pharmaceutical industry. Operating at the highest ethical & privacy standards and ensuring adherence to corporate and legal regulations, this team is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …BICR experience; regularly monitor reviewer metrics for quality control in support of clinical trial endpoint data , and collaborate with Imaging CRO on ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... technology transfer, site-to-site technology transfers and PPQ as needed. Conduct data review and analysis, data -driven decision-making process, and support… more
