- Tris Pharma (Monmouth Junction, NJ)
- …to: Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, ... and vendors across all phases of drug development; Ensures compliance with established clinical and regulatory guidelines, operating systems and procedures in … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes to regulatory authority requests or communication for assigned clinical studies - ... CTD submissions/Others - May support Common Technical Document (CTD) submissions by collaborating with ... Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist Lead, Clinical Safety Physician(s),… more
- Novo Nordisk Inc. (Atlanta, GA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Aequor (Thousand Oaks, CA)
- …degree in biology, chemistry, or other scientific field 5&plus years in writing clinical and regulatory documents Ability to optimally operate in an environment ... to analyze medical data and interpret its significance Sophisticated knowledge of scientific/ technical writing and editing and of related regulatory guidance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and reporting capabilities, incl. creating reports and dashboards of key regulatory data/metrics from across systems, leveraging technical integrations and ... as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs, and Regulatory Affairs (CMR), staying ... About the Department The Clinical Development, Medical and Regulatory (CMR)...SOPs, KPIs, internal processes; Track and measure specific CMR technical metrics. Work to accelerate innovation across CMR functions… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and solutions. Support product launch activities by partnering closely with Supply Chain Technical Operations teams and Global Regulatory Leads to release high ... veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific,… more
- Merck & Co. (Ames, IA)
- …with primary responsibilities in (IA, SD, MN) and is responsible for providing technical support to Sales and Marketing for our Company's Animal Health products ... with a primary focus on the Dairy Industry. Responsibilities include providing technical support for Ruminant products and programs, including response to product… more
- Merck & Co. (Rahway, NJ)
- …related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory , Statistical Programming, Data Management, and our ... that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.Independently identifies and anticipates technical or… more
- Merck & Co. (Rahway, NJ)
- …support for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory , Statistical Programming, Data Management, and other ... that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.Independently identifies and anticipates technical or… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to ... across two co-leader roles, and includes operations that support end-to-end GMP clinical supply manufacture and product/process development, as well as oversight of… more
- Novo Nordisk Inc. (Pittsburgh, PA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory , Statistical Programming, Data Management, and ... in strategic planning of projects.Represent statistics in meetings with investigators and regulatory agencies in discussions about clinical trial issues and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose ... Complies with the protocol, Policies, SOPs, external/internal standards, pertinent Good Clinical Practices (GCPs), applicable regulatory requirements, and other… more
- Merck & Co. (North Wales, PA)
- …critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation & Adaptive Integrated ... working to manage risk and central analytics and ensure exquisite oversight of our clinical trials. It is also business critical the integrity of data is maintained… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies. This translational role resides within… more
- Merck & Co. (Rahway, NJ)
- …across the organizations (Research Division/Manufacturing Division), such as Analytical, Quality, Regulatory CMC, and technical functions, to ensure timebound ... new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the… more
- Tris Pharma (Monmouth Junction, NJ)
- …management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality, etc. to ... safety information updates, potential risks mitigation, etc. Collaborates with appropriate clinical , medical, quality and regulatory counterparts and others… more
