- Merck & Co. (North Wales, PA)
- …and translational research strategy to test the hypothesis.--Alignment, risk mitigation & strategy implementation:- align with asset development team strategy.- ... scientific insight to identify gaps and risks, pro-actively develop mitigation plans.- Work with matrixed stakeholders to ensure implementation.--Collaborate with… more
- Eisai, Inc (Nutley, NJ)
- …processes to protect the organization's infrastructure assets.7. Risk assessment and mitigation : Collaborate with the Global Security & Compliance team to conduct ... identify potential security risks and vulnerabilities. Develop and execute risk mitigation plans, working closely with cross-functional teams to implement necessary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for novel safety issues requiring safety surveillance and/or risk mitigation .Responsibilities- Research and Nonclinical Development: For select drug candidates, ... changes to the benefit/risk balance. Provide expert input on surveillance, assessment and mitigation of changes to the risk profile or emerging risks during exposure… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Jazz Pharmaceuticals (Philadelphia, PA)
- …evaluated and communicated. Collaborate with stakeholders on remediation and risk mitigation activities, including tracking and progress of action plans across ... compliance, policy, and process gap remediation activities and risk mitigation activities in partnership with internal business partners.Manage dashboards that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality oversight and strategic quality advice to the ... CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for quality oversight of marketed products in collaboration with internal QA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with various therapy area communications/global/NNI decisions/support Risk Identification and Mitigation : Identify potential risks and develop contingency plans to ... mitigate any issues that may impact therapeutic area business operations processes Resource Optimization: Lead the formulation and oversight of the therapeutic area budget, optimizing resource allocation for development and commercialization activities… more
- Merck & Co. (Rahway, NJ)
- …build status/progress.- Ensuring issues and risks are tracked and mitigation plans are in place.-Educational Requirements:Bachelors Degree required. Concentration in ... Computer Science preferred.Required Experience: Minimum of 5 years of IT warehouse experience.Demonstrated working knowledge of end to end Material Handling processes & integrations.Technical knowledge and experience in SAP; specifically SAP warehouse design… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …targets and including communication of updates Ensures proactive risk identification and mitigation planning for assigned clinical trial sites Drives and tracks site ... activation and start-up activities with clinical trial sites to support trial start-up strategies Provides system and device expertise to train and support clinical trial sites Ensures ongoing collection and review of relevant documentation eg, related to… more
- Novo Nordisk Inc. (Phoenix, AZ)
- …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
- Merck & Co. (North Wales, PA)
- …assessment of the probability of regulatory success together with risk mitigation measures.Lead the development, communication, and review of the CMC Regulatory ... Strategy Document for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change documentation according to defined timelines.Manage execution of CMC documentation including… more
- Merck & Co. (Rahway, NJ)
- …periodically (eg quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide ... relevant feedback to the CQOL and Head of CQO as appropriate. Responsible for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to: 1) Facilitating and monitoring CTT oversight of vendors; 2)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …marketing leads. Uses business and launch expertise to inform risk mitigation strategies and assesses potential resourcing needs Best Practice Integration: Capture ... lessons learned and best practices to apply to future brands and launches. Collaborate with internal cross functional stakeholders to incorporate these into marketing strategies and execution across the portfolio and ensure the democratization of any learnings… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …marketing leads. Uses business and launch expertise to inform risk mitigation strategies and assesses potential resourcing needs Process and Operations Management: ... Work with internal launch collaborators to ensure successful and timely launch process management. Oversee completion of launch readiness tasks, ensuring a standardized approach across brands and that resourcing is in place to support launch strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and leads issue resolution meetings. Leads risk identification, prioritization and mitigation planning processes.Identifies and recommends PM best practices for the ... broader GPM&L organization. Ensure Project Team awareness of the Global Development Process (GDP). Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Dx Scientist for each program.Communicate CDx program issues, create and track associated mitigation strategies to minimize risk, and align with the CDx Lead to ... escalate issues to the proper stakeholders when necessary.Organize and facilitate global CDx team meetings and interactions with each Diagnostic partner (eg Joint Project Teams). Additionally, build and maintain strong partnerships and rapport with external… more
- Merck & Co. (Rahway, NJ)
- …Operational Technology environment, identifying potential vulnerabilities and recommending mitigation strategies.Define and enforce access management policies and ... controls, ensuring that appropriate permissions and privileges are granted based on a least privilege model.Design and implement secure identity and access management solutions, integrating with both on-premise and cloud-based environments.Develop and maintain… more
- Merck & Co. (Rahway, NJ)
- …and potential threats in the Zero Trust architecture, and develop mitigation strategies.Mentor and train junior engineers on Zero Trust concepts, technologies, ... and best practices.Stay up-to-date with the latest advancements and trends in Zero Trust and other security technologies, evaluating their applicability to our organization.Requirements:Bachelor's degree in computer science, information technology, or a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to LOB and external contracting entities and propose effective solutions for mitigation Ensure compliance with government rules and regulations relating to the ... contractual and budgetary aspects of contracting with health care systems, health care professionals and organizations ie fair market value, transparency reporting, etc. Physical Requirements 0-10% overnight travel required. Qualifications Bachelors' degree… more
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