- Merck & Co. (Rahway, NJ)
- … technical information effectively.-Good understanding and working knowledge of clinical research, phases of clinical trials,-current GCP/ICH & country ... site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands… more
- Novo Nordisk Inc. (Irvine, CA)
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has ... vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs,… more
- Merck & Co. (North Wales, PA)
- …relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data Integrations, ... trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety... Trials are used to support drug applications and regulatory submissions to health authorities globally.Trial Data Management (TDM)… 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 ... other areas within NACD, CMR and global partners Demonstrates technical proficiency within responsible areas, stays up to date...of more recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical ... operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close… 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 ... you ready to make a difference? The Position Provide proactive support and technical assistance to more experienced regulatory personnel. Identify issues and… more
- Aequor (Newbury Park, CA)
- …and communicate scientific/ clinical information, Organizational skills. Knowledge of clinical regulatory submissions including IND, sIND, BLA, and sBLA ... Lead or Manager and will assist in the creation and submission of regulatory documents. Technical : Proficiency in Microsoft Suite (Outlook, Word, Excel,… 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
- BioAgilytix (Durham, NC)
- …complete and scientifically sound product submissionsPrepare pre-market submission reports / technical files / clinical trial applications per the requirements ... you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory … 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 organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations, Non- Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and external ... regulatory requirements Work with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research, Medical Writing, Program Management, CMC… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations, Non- Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and external ... Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements Work with, Clinical Operations, Non- Clinical Research,… more
- Merck & Co. (North Wales, PA)
- …innovative.-Primary responsibilities:Provide statistical leadership and support for early-stage clinical oncology programs.Interact with Clinical , Regulatory ... regulatory agencies, or individual investigators.Independently identifies and anticipates technical or other potential problems arising in the design, conduct,… more
- Merck & Co. (Irving, TX)
- Job DescriptionThis position is responsible for providing technical support to Sales and Marketing for Animal Health products specific to the US Ruminant business, ... the Dairy Industry in TX, KS and NM. Responsibilities include providing technical support for Ruminant products and programs, including response to product inquiries… more
- Merck & Co. (Rahway, NJ)
- …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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform ... with the protocol, Policies, SOPs, external/internal standards, pertinent Good Clinical Practices (GCPs), applicable regulatory requirements, and other… more
- Merck & Co. (Rahway, NJ)
- …for regulatory documents such as Investigational New Drug application, Clinical Study Report, Common Technical Document, and agency- interactions.-You -will ... in the role of-Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to… more
