- Merck & Co. (Rahway, NJ)
- …collaboration.Oversight to ensure appropriate scientific and operational training for staff members. Clinical Operation Management : Ensures a single point of ... adequate and-appropriate resourcing for company internal clinical trial portfolio.- Clinical Research Organization (CRO) Senior , Regional and local Leadership… more
- Merck & Co. (Rahway, NJ)
- …to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. ... analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works... Skills: strong knowledge of the principles of project management and clinical customer relationship management… more
- Merck & Co. (Rahway, NJ)
- …to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. ... Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management . - Technical… more
- Merck & Co. (Rahway, NJ)
- … Visualization, Machine Learning, Software Development, Stakeholder Relationship Management , Waterfall ModelPreferred Skills:Job Posting End Date:03/31/2025 *A job ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Genmab (Plainsboro, NJ)
- …readiness and regulatory compliance.Maintain relevant sections in Clinical Trial Management Systems and ToolsDrive the Operational Data Base review for ... trial objectives are met on time and within budget. Senior Clinical Trial managers are expected to...the trialEngage in Risk Based Quality Management activities to enhance data quality and… more
- Formation Bio (New York, NY)
- …development through regulatory submissions and approvals. Ability to collaborate cross-functionally with Clinical , Data Management , Programming, Data ... ability to convey complex statistical concepts into actionable insights for non-statisticians, senior management , and regulatory agencies. Proficiency in SAS, R… 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical ... high-performing environment.Lead complex GCDS Operations projects within the area of clinical drug supply management .Oversee inspection readiness and ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Senior , Clinical Informatics leads the functions in the Clinical Data Science & Evidence (CDSE) department of NNI focused on clinical ... or clinical fellowship in informatics-related area (health informatics, clinical informatics, nursing informatics, health informatics, epidemiology, data … 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Senior CQV Specialist as part of the Commissioning and Qualification team based in Raritan, NJ. Role OverviewThis position will be ... for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be… more
- Merck & Co. (Rahway, NJ)
- …and develops value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes ... Job DescriptionRole SummaryUnder the guidance of a senior leader, a Senior Principal Scientist/...by local subsidiaries in their local HTA submissionsDevelops supplementary clinical data package in close partnership with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Legal, Compliance, Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able ... & independently in order to accomplish objectives. Relationships Reports to the Senior Director /Director Program Management Lead. Key internal relationships… more
- Merck & Co. (Rahway, NJ)
- …role is accountable for ensuring each inline team has robust lifecycle- management plans, appropriate and rigorous technical support processes to support ... manufacturing sites, proactive risk management , performance monitoring, and continuous improvement.-Experience with autoinjectors, prefilled syringes, and other drug… more
- Merck & Co. (Rahway, NJ)
- …assets/biomarkers (including Regulatory, Commercial, Business Development, Project Management , Operations, Clinical Development, Statistics, Bioinformatics, ... execute assigned projects as needed, eg ordering samples, QC of incoming clinical trial biomarker results, assay/ data transfer troubleshooting, etc. Education… more
- Merck & Co. (Rahway, NJ)
- …contribute to value evidence strategies for in-line and pipeline products. Obtain senior management approval of value evidence generation plans. Provide outcomes ... improve patient health outcomes. Under the guidance of a senior leader, this individual will support one or more...dossiers for US payers, and Global Value Dossiers.Develop supplementary clinical data package for submission to Health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and support health care professionals though robust medical education initiatives. The Senior Global Medical Manager will leverage data -driven insights and ... Boston Global Development leadership team on occasion. May interact with senior leaders/leadership, on occasion. Essential Functions Stakeholder Management :… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and site staff, Health Systems, Contract Research Organizations and Site Management Organizations etc.) Establish and manage senior level relationships ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …non-compliance such as: different approaches to data review in conjunction with Data Management and Clinical Science, audit trail review for non-logical ... achieve a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct....CSM to improve quality and ensure patient safety and data quality and integrity.Establish, measure, analyze and report on… more
