- Merck & Co. (Rahway, NJ)
- …Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development , regulatory, quality and ... to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The position serves as the lead of Clinical Data Science & Evidence (CDSE) operations. In their role, they ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Merck & Co. (Rahway, NJ)
- … Director at this level will be expected to lead a Product Development Team (PDT) through late-phase clinical development and into post-licensure ... journals. The Clinical Director will also contribute to establishing Vaccine Clinical Development Strategies and executing short- and long term research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross functionally with multiple functions and groups throughout the US organization, Clinical Development , Research & Early Development , other affiliates, ... Prioritizes phasing of objectives based on engagement objectives and sales forecasts. Lead the development and execution of annual and long-term brand… 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 ... to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the… more
- Merck & Co. (Rahway, NJ)
- …depth and breadth of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance ... Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal experience during… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall portfolio ... at the program level through the operational resources assigned to their program . May on occasion represent Global Clinical Operations on the Strategy and… more
- Merck & Co. (Rahway, NJ)
- …is expected to be experienced in mammalian cell culture or purification process development , tech transfer of clinical or/and commercial processes, and pertinent ... talent development skills. Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines, … more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners,... and operational management of Formation Bio's quality assurance program to support the growing drug development … more
- Merck & Co. (Rahway, NJ)
- …the project as needed.-This includes the following activities:1. Is involved in late clinical development planning (LDP) to ensure that study designs are ... clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a...software for planned analyses and ascertains needs for potential program development of novel statistical methodology.7. Analyzes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …track training completion rates to ensure compliance with safety and regulatory requirements Lead the development and delivery of training on case processing, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Merck & Co. (Rahway, NJ)
- …execute, design verification strategies for assigned drug-device combination product program (s) for successful clinical introduction(s) and commercial market(s) ... plan, protocol(s), and report(s) that demonstrate design output(s) meet design input(s). Lead establishment of test methodologies, including method development … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US Operations. This individual will also work closely with global colleagues in Research & Development The role will lead the development and execution of ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… 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 ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...& Technical Complaints Contact Center. This role ensures the program and its agents are set-up for success while… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …talent and benefit from a range of possibilities for professional and personal development . Are you ready to realize your potential? The Position The purpose of ... supporting various company initiatives and functions such as Marketing, IT, Clinical , Research, Operations, Patient Support Programs, and Digital Health Lead… 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 ... to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the… 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 ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...Review Board as required. Essential Functions Leadership & Oversight Lead and manage the Medical Review Case Processing team,… 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 ... to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include delivering high-performing teams across designated therapeutic areas that lead to best-in-class field teams and defining capabilities and frameworks ... for patient support field teams. This role will oversee program operations, compliance, vendor contracts and relationship management. AD will drive collaboration and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere… more
