- 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
- 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
- Merck & Co. (North Wales, PA)
- …capabilities team to ensure successful program level management, tracking and risk mitigation to ensure delivery of the Omnichannel Roadmap. Primary Job Tasks Lead ... key omnichannel projects across the US, including the definition and execution of project scope, goals, and deliverables Responsible for the E2E program management of the current omnichannel projects and managing the development of new programs and initiatives… more
- Merck & Co. (Rahway, NJ)
- …contact with vendors/collaborators for timeline tracking, issue resolution and risk mitigation . Skills and Knowledge: Well organized and methodical approach to ... problem solving. Ability to understand and resolve conflicting needs of key stakeholders. Proactively identify and resolve and/or escalate study related issues. Participate in process improvement initiatives or improving efficiency as needed. Good… more
- Merck & Co. (North Wales, PA)
- …Support as a sourcing expert in cross functional and risk mitigation teams. Identify and promote improvement opportunities together with suppliers. Negotiating ... with suppliers to secure advantageous terms Building and maintaining long-term relationships with Suppliers. Estimating risks and applying risk minimizing techniques. Procurement support for product transfer activities (internal and external). - Location for… more
- Merck & Co. (Rahway, NJ)
- …contact with vendors/collaborators for timeline tracking, issue resolution and risk mitigation . Skills and Knowledge: Well organized and methodical approach to ... problem solvingAbility to understand and resolve conflicting needs of key stakeholdersProactively identify and resolve and/or escalate study-related issuesParticipate in process improvement initiatives or improving efficiency as neededGood understanding of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Evaluation: Assists manager in assessing new signals.Safety Expert - Risk Mitigation & Communication: Communicates any safety concerns to management and relevant ... team members.Reports and Submissions: May contribute to writing minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. Qualifications: Successful candidates will be able to meet the qualifications below with or… 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
- Merck & Co. (Rahway, NJ)
- …management experience including resource management, budget forecasting, and risk assessment/ mitigation planning.Comfort with working in a fast-paced and dynamic ... environment.Strong knowledge of Biologics CMC landscape including knowledge of GMP and relevant HA guidelines.Experience with a wide variety of analytical methods, including biochemical and/or biophysical characterization.Demonstrated track record of working… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …This includes support of project schedules, resource allocation, and risk mitigation .Participate in brainstorming for new projects, development of project charters, ... and coordination of project timelines across all projects and teams.Provide insight on project management methodologies/best practices that drive innovation in project management processes and tools.Monitor, analyze, and interpret trends in order to become a… more
- Eisai, Inc (Raleigh, NC)
- …externally. Tracks progress against agreed upon targets. Develops and implements mitigation plans for at-risk items. Performs regular assessments of project ... execution to identify areas for improvement.Tracks project performance periodically to ensure both short-term and long-term goals are met. Requirements Education: Bachelor's degree in Engineering, Science, or Supply Chain related field required. Technical: 5+… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance risks impacting research unit across DSG, and assures that mitigation strategies are in place.Responsible to engage directly with Health authorities ... such as FDA, EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts. ResponsibilitiesLeads nonclinical QA function to implement a quality system in accordance with 21CFR part 58 (Good… more
- Novo Nordisk Inc. (Boulder, CO)
- …work with CMO's to ensure the continuous supply of product and apply risk mitigation strategies, as well as perform formulation studies in a laboratory setting as ... needed. Relationships This position reports to the Executive Director, Manufacturing. Essential Functions Manage all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved protocols,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Safety Scientists.Responsibilities Risk Management (Signal identification, evaluation, mitigation ):This position serves as the Clinical Safety Scientist ... Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Eisai, Inc (Nutley, NJ)
- …processes (data privacy, GxP, JSOX).Manage Enterprise IT risks, dependencies, mitigation plans and execution.Collaborate globally and regionally to align IT ... policies, procedures, and controls.Develop and implement compliance policies, procedures, and controls.Ensure compliance with local, regional, and industry standards.Work with non-IT compliance staff (legal, audit, corporate compliance).Focus on compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contract, including project management, supply analysis, supplier identification, risk mitigation , sourcing execution, high level negotiations, award of business ... etc), with senior business stakeholders. Consult senior Business stakeholders with procurement insights and guidance to influence and help inform business decisions and drive optimal value. Possesses a large range of diverse knowledge of multidisciplinary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …program risks, quantification of risks for prioritization, and management and mitigation plans. Effective management, impact analysis, and resolution of escalated ... risks/issues by project manager(s)Program budget management including preparing and requesting release of funds over the lifecycle of the program through DS governance. Initiating, follow through, and completion of necessary legal documents/agreements for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …building where required.Identifies risks and develops and implements risk mitigation plans.Interfaces with senior Scientific and Infrastructure Committee members on ... key scientific and infrastructure issues to facilitate the OEDC's role in defining oncology early development strategy and execution for DS.Monitors OEDC metrics (ie KPIs, KQIs, and other speed and quality metrics) through the use of dashboards.Coordinates… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies including communication of regulatory risks and associated mitigation plans to management and other internal stakeholders Perform regulatory ... review of all clinical and nonclinical documents for submissions, eg, clinical protocols and study reports, preclinical reports, investigator brochures, application summary documents, etc. Research and analyze the evolving competitive and regulatory landscapes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …chain disruptions, and market dynamics. Develop contingency plans and risk mitigation strategies to safeguard the portfolio's performance and long-term viability ... Loss of Exclusivity (LOE) Management: Anticipate and plan for upcoming LOEs, including the development of strategies to mitigate the impact of generic competition on revenue and market share. Evaluate opportunities for lifecycle management strategies, such as… more
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