- 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 ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a ... for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product ... areas centered around rare diseases and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for...Team to inform clinical development, commercialization, market access, and other cross-functional strategic… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director, ... production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation… more
- Merck & Co. (North Wales, PA)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... medicine.Accountable for the operational planning, feasibility, and execution of a clinical protocol.- May lead team in key study planning, development and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trial sites when directed by management to check principles of assuring patient safety , data integrity and regulatory compliance are sufficient Monitor and ... 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
- Merck & Co. (North Wales, PA)
- …complex data preprocessing, filtering, and manipulation; programming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic ... statisticians and other project stakeholders.Primary Activities:Programmatically synthesize preclinical / clinical data into analysis ready structures from… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Biostats Data Mgmt. & Data Ops. for statistical support and data capturing; with Clinical Safety and Pharmacovigilance for safety endpoint ... study with health authority requirements; with Quality Assurance to guarantee subject safety and privacy and data integrity. Additional Study-Related Activities:… more
- Merck & Co. (Rahway, NJ)
- …and Mentoring Train and mentor junior scientists in experimental design, execution, and data interpretation Safety and Compliance Contribute to a safe and ... To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product ... areas centered around rare diseases and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for...Team to inform clinical development, commercialization, market access, and other cross-functional strategic… more
- Novo Nordisk Inc. (Boulder, CO)
- …Plan, manage & perform validation activities at the Boulder Pilot and Clinical GMP Plants. Handle simple to moderate complexity validation projects. Support ... address & eliminate potential reoccurrence of the failures Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria Responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize safety events for assigned product. ... analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... Compliance, Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Catalent (Harman, WV)
- …materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality system functions, as needed. The Role ... all cGMP manufacturing operations and documentation and adhering to safety guidelines Oversee daily activity for the group to...report via a PowerPoint presentation to be reviewed by Senior Management on a periodic basis. Track action items… more
- Insmed Incorporated (Bridgewater, NJ)
- …role, you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology ... standards.Provide scientific guidance on study design, execution, and interpretation of nonclinical safety data ; and oversee nonclinical safety studies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical development plans, and addressing all regulatory, drug and patient safety , data , CMC, IP, patient selection, market acesss and and other relevant ... all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting… more
- Insmed Incorporated (Bridgewater, NJ)
- …and Logistics plays a crucial role in supporting both the commercial and clinical supply chains at Insmed. The primary focus is on managing import/export ... The role also requires contributing to build and maintain Insmed's master data management practices, as well as implementing and monitoring DSCSA compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... Understand the Novo Nordisk value chain, eg, corporate development, research, clinical development, manufacturing and commercial operations to be in optimal position… more
- U of C NORC (Bethesda, MD)
- …rich data on health care priorities including the uses of electronic clinical data in research, and the applications and effectiveness of health information ... JOB DESCRIPTION:NORC at the University of Chicago is seeking a Senior Research Associate I to join the Health Sciences Research Department. Our Health Sciences staff… more
