- Merck & Co. (Rahway, NJ)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also assist… more
- Merck & Co. (Rahway, NJ)
- …teams and between teams and stakeholders, ensuring a collaborative environment. Risk Management :-Identify potential risks and issues, facilitating discussions ... Management System Development, Product Management , Requirements Management , Risk Management , Stakeholder Engagement, Stakeholder Relationship… more
- Merck & Co. (Rahway, NJ)
- … Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management , Regulatory Reporting , Regulatory Training, SAP Global Trade Services, ... Material(s):n/aRequired Skills:Audits Compliance, Audits Compliance, Compliance Program Development, Currency Risk Management , Customs Valuation, Detail-Oriented, Documentations, Ethical… more
- Merck & Co. (Rahway, NJ)
- …and inspire accountabilityEthical, resilient, and committed to excellenceSkilled in risk management , team facilitation, and strategic planningExperience in ... and biologics commercialization within the expansive Biologics S&T portfolio. Reporting directly to the Biologics Drug Substance Commercialization Leader, you… more
- Merck & Co. (Rahway, NJ)
- …for large molecule products.Coordinate project planning, resourcing, progress reporting , troubleshooting and people management .Provide technical oversight ... timely and accurate information and status updates to project sponsors and management .Champion compliance and safety; promote a culture of diversity, inclusion, and… more
- Merck & Co. (Rahway, NJ)
- …Project Management , Project Risk Assessments, Regulatory Affairs Management , Regulatory Reporting , Regulatory Training, SAP Global Trade Services, Social ... and convert them into actionable solutions and process specificationsStrong project management skills and ability to conduct complex reporting processesSustained… more
- Merck & Co. (Rahway, NJ)
- …will be responsible toCoordinate project planning, people, resourcing, progress reporting , and troubleshooting in a matrixed organization.Serve as the ... cell bank process performance across programs, support timeline creation and management of work packages within project teams. Monitor and project resource… more
- Merck & Co. (Rahway, NJ)
- …Machine Learning, Pharmaceutical Sciences, Process Models, Programming Logic, Project Management , Reporting Management , Report Preparation, Social ... (RaDS-IT. We are responsible for developing and applying techniques for quantitative cost- risk -benefit analysis of complex scenarios in R&D. We deeply engage with… more
- Merck & Co. (Rahway, NJ)
- …its customers, and shareholders. The scope of this group includes strategic program management , enterprise strategic planning, risk management , as well as ... Market Access and Analytics expertise are particularly valuable for this role. Reporting to the Associate Vice President, Head of Commercial Strategy… more
- Merck & Co. (Rahway, NJ)
- …and consumable inventory. - Provide input for incident root cause analysis, reporting , and action items. - Facilitate and drive building improvement projects and ... to promote fast and efficient closure. - As needed, safely perform High Risk Work involving hazardous energy control. - Identify and follow through on opportunities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in a fast-paced environment, continuous improvement, project management , change management , and risk management . Responsibilities: Leadership, Direction, ... rare diseases and immune disorders. Summary: The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery of laboratory data in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leading safety physicians and scientists in individual case medical review, aggregate reporting , risk management , and/or translational researchMust have ... product safety team in critical areas such as individual case medical review, risk management , aggregate safety reports, and translational medical safety. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... CRO to ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other risk … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Job Summary: A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position ... of the Head of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout the course of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety ... of medical accountability and oversight for one or more clinical trialsMatrix management responsibilities across the internal and external networkManages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documenting/tracking associated CAPAs or process deviations, and coordinating the end-to-end management of these. They will also be responsible for conducting ... proactive risk assessments related to regulatory processes on a consistent...teams to support GRA meeting company policies for quality management (eg, completing requests/initiatives from the GSOP Committee)Proactively manage… more
- Eisai, Inc (Nutley, NJ)
- …from you. Job Summary:The Associate Director, Global Alzheimer's Disease Project Management is responsible for facilitating the operational aspects of the lecanemab ... global launch plan, provide project management , and serve as liaison between project team, global...and manage the project schedule to identify planning gaps, at- risk activities and propose mitigation measures to keep projects… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evaluate, and implement technology and data analytics solutions that enhance compliance monitoring, reporting , and risk management Utilize data analytics to ... assess and mitigate identified ethics and compliance risks as part of NNI's risk management program. This role leverages innovative technology, data analytics… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Degree and CPA required At least ten years' experience in financial management and reporting with significant experience/exposure to public accounting and ... potential with us? The Position Responsible for oversight of financial reporting , general accounting, related internal controls, and establishment of financial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in support of company objectives, operating model decision, mitigate decision risk , drive action plan development and ultimately improve commercial and clinical ... Requirements 10-20% overnight travel required Development of People Ensure that reporting personnel have individual development plans (IDP), with annual goals and… more
