• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and immune disorders.Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical ... Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle Independently leads activities without supervision… more
    HireLifeScience (03/26/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Act Drive organizational awareness and understanding of political environment & financial risk Assists in preparing any pricing/policy related analysis for ... pricing analytics/insights for strategy evaluation & guidance on future outlook Owns analysis for Risk Report and investor relations document Serve as a key lead… more
    HireLifeScience (03/26/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …Quality and the CMO teams to collaboratively drive the deliverables and timelines. Conduct risk and gap analysis , maintain risk registry and develop ... accurate update on the timeline, status of the projects, risk and mitigation strategy to the manager ...projects, risk and mitigation strategy to the manager and cross functional stakeholders. Requirements BS or more… more
    HireLifeScience (02/21/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …as related to combination products quality metricsReview PQC monthly metricsRisk assessment/ Analysis / Risk management file including annual review of ... requiredCertified Quality Engineer or similar preferredRequired/Preferred skillsDesign Control and Risk Management experience requiredStatistical expertise preferred (Minitab or other… more
    HireLifeScience (03/12/24)
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  • Exela Pharma Sciences, LLC (Lenoir, NC)
    …CFR Part 11 in a manufacturing settingDemonstrated application of FMEA, Risk Analysis , Validation principles, guidelines, and industry best practiceDemonstrated ... validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter… more
    HireLifeScience (03/16/24)
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  • George Washington University (Washington, DC)
    …guidance on matters concerning indemnification, subject injury, intellectual property, risk management, insurance, applicable rules and regulations pertaining to ... with the final language in the clinical trial agreements, reviews by risk management, Hospital, and University general counsel, and all communications with sponsors,… more
    JobGet (03/01/24)
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  • Catalent (San Diego, CA)
    Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... a member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational… more
    HireLifeScience (02/14/24)
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  • Lundbeck (WA)
    …- Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager , State Policy and Strategy position is responsible for serving as the ... on Lundbeck's products and goals. In addition, this individual will lead analysis of state policy issues that could impact Lundbeck's patients, including assessment… more
    HireLifeScience (01/20/24)
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  • Lovelace Biomedical Research Institute (Albuquerque, NM)
    …Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract ... contracts and compliance of the Office of Research Contracts (ORC).The Contracts Manager - Federal Contracts and Compliance will work closely with LBRI… more
    HireLifeScience (01/18/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Advises leadership and stakeholder functional areas of contractual rights, obligations and risk analysis , as necessary Oversees contractual requirements for new ... through final approval. This includes the strategic assessment, deal structure, analysis , forecasting and reporting of contract profitability of customer segments… more
    HireLifeScience (01/25/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …wide range of difficult problems. Relationships This position reports to a manager in Project Execution. Works under only general direction. Independently determines ... and provides business need analysis and process analysis towards providing IT...to ensure compliance with contract expectations Understands & Applies Risk Management Practices: Ensures processes, projects and systems meet… more
    HireLifeScience (03/12/24)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …short- & long-term targets. Provides the organization with information & business analysis to support decision processes & follow up. Assists with improvement ... projects with business impact analysis & continuously improves business information processes. Acts as the implementation partner for Line of Business (LoB) when… more
    HireLifeScience (03/15/24)
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  • Blanchard Valley Health System (Findlay, OH)
    …is to support the Legal, Risk Management, and Corporate Compliance Department. The Risk Manager is responsible for planning and directing the Risk ... in developing and implementing strategic initiatives, including those relating to enterprise risk management. Duty 2: Leads organization-wide systems for risk more
    JobGet (03/13/24)
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  • Merck & Co. (Durham, NC)
    …by policies, procedures, and business plan; receives limited guidance from manager . Coordinate interactive planning sessions with site IPT's and contractors to ... and maintenance databasesExperience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean… more
    HireLifeScience (03/26/24)
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  • FastTek Global (Troy, MI)
    Sr. Technology Risk Engineer #988143 Job Description: Position Summary: The Sr Technology Risk Engineer is responsible for the delivery of the program elements ... of all first line of defense risk activities directly or indirectly impacting Information Technology and Information Security within us. The Sr Information… more
    JobGet (03/26/24)
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  • Merck & Co. (Rahway, NJ)
    …method validations, method transfers, analytical methods, specifications, certificates of analysis , etc. - Accountable for all assigned projects and communication ... in SOP and quality-related system document approval. - Other duties as assigned by manager for the flexible functioning of the work group. - Support metrics by… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    …method validations, method transfers, analytical methods, specifications, certificates of analysis , etc.- Accountable for all assigned projects and communication of ... such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter… more
    HireLifeScience (03/23/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …resources as required. Direct reports will include Application Architects, Project Manager and Business Analyst. Essential functions Analyzes and fulfills business ... and/or functional area Manages the implementation and operation of Adobe Experience Manager (AEM) platform (on-prem and in the cloud) solution which fully meet… more
    HireLifeScience (03/06/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …system related issues and discrepancies. Relationships This position reports to a manager in Business Applications. The individual interacts with all levels of the ... activities to ensure compliance with contract expectations Understands & Applies Risk Management Practices: Ensures system design adheres to compliance requirements,… more
    HireLifeScience (01/25/24)
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  • Dexian - DISYS (Houston, TX)
    …and make complex materials clear and engaging.* Utilizes qualitative and quantitative risk analysis best practices to provide a clear decision-making framework ... Role Description Summary:Cybersecurity Risk Analyst supporting Merger and Acquisition integrations and...of IT risks to Integration and Divestment Cyber Workstream Manager .* Develops cybersecurity decision support packages to provide clearly… more
    JobGet (03/21/24)
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