- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director, Issues Management and Crisis Mitigation is responsible for driving comprehensive issues preparedness and management strategies and ... conducting risk assessments and scenario plans, developing issues preparedness and mitigation plans and coordinating and executing crisis management strategies and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management operations of the E&C team, ensuring the identification, assessment, and mitigation of compliance risks while maintaining and strengthening the culture of ... Essential Functions Develop and implement a comprehensive risk assessment, management and mitigation strategy for the E&C function and oversee Policies & Training,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Tracking of activities in terms of timing, anticipated risk, and mitigation of issues/conflict resolutions Encouraging overall operational excellence across all ... planning.Lead issue resolution meetings. Lead risk identification, prioritization, and mitigation planning processes across the Franchise.Manage the agendas for… more
- Merck & Co. (Durham, NC)
- …as a member of the Sterility Assurance team providing knowledge for risk mitigation and contamination control. -The candidate will gain a robust understanding of the ... Quality Sterility Assurance team, providing support to ensure compliance risk mitigation , contamination control and sterility assurance of the facilityGain robust… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential ... risks to the study and propose mitigation plans. CRO and Quality Oversight:Responsible for oversight of all CROs utilized within their therapeutic area. May… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …out and reporting.Proactively assess potential risks to the study and propose mitigation plans.Monitor study budget against trial progress and bring deviations to ... initiation and enrollment activities at the country and site level and develop mitigation strategies in collaboration with the CRO.Coordinate with the CRO to prepare… more
- Aequor (South San Francisco, CA)
- …the integrated Quality Risk Management Plan (iQRMP) and associated risk mitigation and control strategies, provide processes and tools for oversight of ... (CtQ) factors, development of risk control strategies, and implementation of risk mitigation activities. Collaborate with the global RBQM Center of Excellence (COE)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …governance and associated special projects Identifies, analyzes, and supports the mitigation of potential ethics and compliance risks to the organization, including ... proactive approach to ethics and compliance, focusing on partnership, risk mitigation , prevention, and the advancement of business development areas, including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Affairs, Clinical Operations. Formulates strategic approaches for risk mitigation for global products/TAs and ensures these activities are properly ... carried out. Serves as company expert for risk mitigation and oversees the global communication of important product safety information.Create and align processes… more
- Genmab (Plainsboro, NJ)
- …will be supporting team members through troubleshooting, problem-solving, and developing mitigation plans for complex issues related to packaging and labelling ... in troubleshooting and problem resolution, ensuring effective development of mitigation plans for operational challenges.Mentor and coach team members, fostering… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …team members to develop, plan and execute on the opportunity or mitigation Process Improvement: Identifying areas for improvement in operational processes and ... implementing changes to enhance efficiency, productivity, and quality Resource Management: Managing resources such as personnel, equipment, and materials to ensure optimal utilization and allocation Recruitment And Onboarding: Primarily responsible for… more
- Merck & Co. (Rahway, NJ)
- …risk assessments, including identifying, evaluating, and analyzing risk mitigation .Education:Bachelor's degree in computer science, Information Systems, or related ... field.Required Experience and Skills: Minimum 7 years of experience consisting of Product and Program Management, Payroll Business and Technical Analyst, with strong focus on Workday/ADP (Cloud Connect for Payroll, PECI, EV6, Etime, Streamline, Celergo, etc.)… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …with established targets and strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based ... Quality Management (RBQM) principles and tools; executes activities relevant to all visit types (Site Selection, Site Initiation, Monitoring, and Closure) for assigned sites and clinical trials Verifies safety reporting and the proper handling, monitoring and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …work procedures/guidance, logs, templates, quality procedures, risk impact assessment mitigation procedures, to maintain audit readiness, data integrity, security, ... consistency and transparency across programs. Support preparations and follow-up actions related to internal audits and health authority inspections. Contribute to the development, maturity, and consistent application of external data vendor access standards… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Leaders about handling of various nonconformances and strategies for mitigation / remediationPerform timely escalations of potential significant quality issues ... to managementRepresent QA Lab Compliance and QA Lab Oversight in Site Escalation, MRB, and Tier meetingsCollaborate with cross functional team (Investigation Management and Functional Area Owners) to align on root cause, corrections, and CPAsProvide insight… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …schedules, and monitor resource allocation.Conduct risk assessments, develop mitigation strategies, and proactively address issues or delays.Lead cross-functional ... teams, providing leadership and clear direction.Maintain strong relationships with internal and external stakeholders, ensuring strategic alignment and effective communication.Provide executive-level communication and reporting on project and program… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …baseline assumptions and market scenarios. Define forecast risks and mitigation strategies. Lead decisions around resourcing allocation and account planning ... to support forecast and product expectations Market and Customer Experience Mapping: Lead TA market analysis, competitor assessment, market sizing, and customer experience insights to shape strategic decisions and plans, being agile to adjust as new insights… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reporting obligations, such as Aggregate Spend and Risk Evaluation and Mitigation Strategy (REMS) including the management and oversight of systems supporting ... these processes. It involves coordinating and ensuring timely reporting of all government requirements and managing related documentation and systems. Additionally, the role includes tracking updates, participating in remediation activities, and keeping E&C… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …agency management, quarterly business reviews and co-pay mitigation strategies.ResponsibilitiesFor pre-launch brands/indications, collaborate with cross-functional ... partners to build and execute on the commercial launch readiness activities for upcoming indications. For in-line brands/indications, support the execution of the annual brand planning process and execution, in order to ensure financial objectives are… more
- Aequor (New York, NY)
- …resource constraints. Risk Management: Proactively identify potential risks and develop mitigation strategies. Monitor project progress and address any issues that ... arise to keep projects on track. Documentation and Reporting: Maintain comprehensive, fit-for-purpose project documentation, including project plans and status reports. Provide regular updates to CX Oncology leadership and other stakeholders to ensure seamless… more
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