- Novo Nordisk Inc. (Irvine, CA)
- …strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(short-term, mid-term, long-term)These will include but not limited to Group Heads in Clinical Development, Asset & Portfolio Management , Global Clinical ... to end in collaboration with GCLs, Physician Scientists and the study team (data management , clinical operation and other functions) to implement clinical … more
- Insmed Incorporated (Bridgewater, NJ)
- …highly strategic view is required. This opportunity will require a focus on all the clinical aspects of the upcoming HS program . Strong leadership skills are a ... amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level… more
- Merck & Co. (Rahway, NJ)
- …& development (R&D) projects (data, analyses, tables, graphics, listings).Strong project management skills; leadership at a program level; determines approach ... to be programmed; an understanding of statistical terminology and concepts.Familiarity with clinical data management concepts.Hands on experience in CDISC and… more
- Merck & Co. (Rahway, NJ)
- …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 ... clinical pharmacology and pharmacometrics of oncology drugs from post-Preclinical...supporting the QP2-I/O Function Lead on oncology development teams.Data management and analysis.On the job, working with senior scientists… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... site feasibility assessment from a physician's perspective- May provide clinical input into the eCRF ( Case Report...management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …throughout the US affiliate and globally if needed; responsible for administrative and management support of field-based FMA Program at Novo Nordisk Inc (NNI). ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...all laws, regulations and policies. Responsible for administrative and management support of field-based FMA Program at… more
- Merck & Co. (Boston, MA)
- …of the Common Technical Document (CTD) and label, including relevant compound/ program life-cycle management .The successful candidate will have an essential ... Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic oversight for the early … more
- Merck & Co. (Rahway, NJ)
- …of the Common Technical Document (CTD) and label, including relevant compound/ program life-cycle management .The successful candidate will have an essential ... Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early … more
- Merck & Co. (North Wales, PA)
- …systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine ... level including the development of electronic submission deliverables.Strong project management skills; A program leader; Determines appropriate programming… more
- MARYHAVEN, INC (Marysville, OH)
- …called the crisis hotline. This may include substance use and mental health counseling, case management and treatment planning for clients who have been referred ... Stabilization Service (MRSS) is a crisis response and stabilization program that pairs a clinical provider with a Parent Peer support. This team responds… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... provides a high degree of technical, project, and people management responsibility. - This SSO Facility Lead role within...members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and… more
- New Narrative (Portland, OR)
- …support specialists, prescribers, and property management partnersSupervisionQMHA Clinical Case Manager will report to the Program Manager and engage in ... description and summary)The Compass Rose Transition-Aged Youth Supportive Living Program (TAY-SLP) QMHA Clinical Case ... Case Manager is responsible for providing case management , skills training, crisis administration, and… more
- Merck & Co. (Rahway, NJ)
- …process development, qualification, and validation; and, design control and risk management techniques to positively support and influence clinical and ... ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key company functions.Represent Device… 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 ... the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to...analytic support to the field team, and assists the Program Development and Training function for the TA. SD… 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 ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Merck & Co. (Rahway, NJ)
- …therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the ... pharmacokinetics (PK) and pharmacodynamics (PD) analysis, model-based meta-analysis (MBMA), clinical trial simulations (CTS), disease progression modeling and Artificial… more
- Merck & Co. (Rahway, NJ)
- …administrative department direction and working in conjunction with internal and external program partners, this individual will support late stage and commercial ... program activities within BDSC.Scope includes:Participates in and/or leads cross-divisional technical teams focusing on late-stage clinical process development,… more
- Merck & Co. (Rahway, NJ)
- …therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the ... PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... computing infrastructure support: Provides systems integration, installation, licensing, version management , and basic troubleshooting; manages incident resolution when escalation… more
