- Bayer (Whippany, NJ)
- …and configuration of AI including implementation of controls. Performs a formal risk assessment based upon the intended use and configuration of AI. Reviews ... the testing/validation of AI. Prepares an AI risk mitigation plan (as needed). Enforce relevant QSDs/LQSDs, documentation...support as needed to the US Partnering & Issue Management organization team-mates on Medical Governance and other relevant… more
- Bayer (Whippany, NJ)
- …therapeutics in the pharmaceutical space, while supporting regulatory and market access requirements in relevant markets.YOUR TASKS AND RESPONSIBILITIESThe primary ... the Target Product Profile, designed for successful regulatory approval and market access for one or multiple treatment indications and/or multiple programs;Develop… more
- Merck & Co. (Rahway, NJ)
- …through commercialization and post- market evaluation.Develop and execute the device risk management strategy, including the creation of device risk ... Job DescriptionThe Senior Scientist, Device Risk Management Lead, is a crucial...and external sites ensuring proper translation and implementation of risk control measures.Analyze information from post- market surveillance,… more
- Merck & Co. (Rahway, NJ)
- …Governance Management , Leadership, Oncology, Operational Excellence, Privacy Compliance, Quality Management , Risk Management and Mitigation, Risk ... to support key programs and initiatives (eg, Marketing, Sales, Account Management , Market Access, Content, Engagement/Activity, Alliances)Understanding of how… more
- Merck & Co. (Rahway, NJ)
- …and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying ... of device development strategies and drive continuous improvement in design control and risk management processes. This individual will be expected to apply… more
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... solutions that enable the Company's innovation while protecting data and mitigating risk . The role requires deep expertise in privacy law, strong communication and… 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 ... ideal candidate will possess innovation, insight, commercial acumen, and broad market perspectives to provide commercial strategy expertise for our company.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manufacturing Execution Systems Lead and will be responsible for providing project management support to the development and administration of EBR and digital ... CMC, and IT. This individual will be responsible for management and delivery of the project plans for electronic...for MES and/or digital projects and ensures that quality, risk , cost, time are managed within the overall approved… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ.Role OverviewThe position will be part of the integrated CMO virtual management team working with our partner JNJ, to oversee the day-to-day business ... Quality and the CMO teams to collaboratively drive the deliverables and timelines.Conduct risk and gap analysis, maintain risk registry and develop mitigation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a ... Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and budget related activities.Process-oriented with strong analytical skills for risk identification and management .Ability to translating complex analytics ... Power BI to support FP&A deliverables such as KPI reporting, monthly management reporting, budget vs. actuals (BvA), rolling forecast analysis, and long-range… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …goals. The Manager will play a key role in vendor management , contract negotiation, and operational procurement excellence.Key Responsibilities Support and lead ... not limited to:Materials: Lab supplies, PPE, MRO, etc.Services: Facility management , logistics, calibration, waste management , etc.CapEx: Equipment purchases,… more
- Sanofi (Morristown, NJ)
- …Scientific External Engagement, Procurement etc ), responsible for timelines, budgets and contingency/ risk management plans to assure successful execution of the ... medical/clinical input to study-related documents such as study plans eg Study risk management plan, Monitoring and centralized monitoring plans Participate in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …environment.Learn new skills, procedures and processes as assigned by management and continue to develop professionally.Support and contributes to projects.Assist ... effectively determine appropriate resolutions that ensure compliance and minimize risk .Ability to collaborate well with stakeholders, customers and peers.Must… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …enhancement and Global harmonization of the supplier qualification program, including management of the electronic systems for this program.Work with External ... and other internal functions to understand and mitigate any compliance risk and establish vendor quality scorecard.Support development and gathering of quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting ... effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and effectively develop others.Ability… more
- Sanofi (Morristown, NJ)
- … Mitigation: Assess risks related to generic competition, regulatory changes, and market shifts. Develop risk mitigation plans to safeguard product performance. ... Proven experience in pharmaceutical leadership, specifically within product portfolio management . Strong understanding of commercial operations, market access,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues, deviations, corrections and remediation ... review of change controls, SOPs, and other documentationParticipates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …changes to the same and their impact on the Carvykti product. Stakeholder management is required to drive and implement documentation template efforts worldwide as ... as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change controls, draft industry… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and effectively develop others.Ability ... be able to discern the criticality of issues and to communicate to management regarding complex issues.Ability to manage conflict and issues that arise with internal… more
