- Legend Biotech USA, Inc. (Raritan, NJ)
- …implement modifications to risk assessment plans. Key Responsibilities Follow QRM (Quality Risk Management ) process per ICH Q9, identify the risk , ... an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Risk Assessment Specialist as part of the Technical Operations team based in… more
- Merck & Co. (Rahway, NJ)
- …project management , ability to lead during ambiguity, analysis and risk -based decision-making and stakeholder management are required for this role. ... and leadership skills in an international environment. -Excellent project management , organizational, risk -based evaluation, and prioritization skills. -Superior… more
- Merck & Co. (Rahway, NJ)
- …country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure ... Job DescriptionPosition Description: Associate Director Data Product Management Job Description We are seeking a strong, highly energetic and collaborative leader to… more
- Merck & Co. (Rahway, NJ)
- …Description: Associate Director, Finance - Animal Health (AH) Global Supplier Management We're looking for an experienced and motivated Finance Leader to ... such as: Vendor selection, contract negotiation & review, supplier risk assessments, savings calculations, financial controls, budgeting, forecasting, and reporting… more
- Merck & Co. (Rahway, NJ)
- …IT organizations to ensure alignment with Platform teams, IT architecture, IT Risk management , support organizations in delivering projects.Contribute as a ... team of developers to deliver solutions across the Facilities Management Product Line. In this role you will be...that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent… more
- Eisai, Inc (Nutley, NJ)
- …stakeholders from EIT and leaders across regions in Compliance, Ethics, Risk Management , Legal, Data Privacy, and Information Protection.Security ... work experience, including at least 5 years of enterprise-level governance and management .Certified Information System Manager (CISM), Certified in Risk and… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, ... in layman's terms to facilitate cross-functional understanding.Development experience in risk -oriented, regulated environmentsDevelopment project leadership with a proven track… more
- Merck & Co. (Rahway, NJ)
- …creating machine learning models and retraining systems. Often, you will have to take a model prototype built by a data scientist and work with the team to put that ... model in production. This will involve making the ...and Clustering models.Understanding of ETL tools for data flow management and pre-processing.Ensures best practices sharing and cross the… more
- Merck & Co. (Rahway, NJ)
- …processes and procedures (internal and external).Working knowledge of design controls and risk management processes for medical devices and combination products, ... including establishment of design inputs, design outputs, design verification, and risk management integration. Expertise in testing, characterization, and… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... launch.- The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build a culture… more
- Merck & Co. (Rahway, NJ)
- …strategies for novel medicines.Contributing to the continuous improvement of the operating model for regulatory activities in the US and globally to execute ... science and regulatory environment.Establishing an effective implementation and oversight model to maintain best-in-industry regulatory compliance.The Vice President Regulatory… more
- Merck & Co. (Rahway, NJ)
- …(including the CTC, CRAs and-COM).-Responsible for creating and executing a local risk management plan for assigned studies.Ensures compliance with CTMS, eTMF ... role is primarily accountable for the end-to-end performance and project management for-assigned protocols in a country in compliance with International Conference… more
- Merck & Co. (North Wales, PA)
- …of status update reports, study close out activities).Leads team for timeline management , risk identification and mitigation, issue resolution.May facilitate and ... as part of a global, cross-functional team. You will apply project management , communication, and collaboration skills in support of our clinical trials.Job… more
- Merck & Co. (North Wales, PA)
- …supporting the development of sophisticated marketing strategies through a comprehensive management of data and analytics, as well as coordinating market research ... to a manageable chronic disease. However, as people with HIV age, the risk of developing comorbidities increases, and they are exposed to antiretroviral treatment… more
- Eisai, Inc (Nutley, NJ)
- …occurrences. This role will be required to provide input into vulnerability management , risk management , security architect, security operations center ... Demonstrated expertise in incident response, threat intelligence, security controls, and risk management .- Solid understanding of protocols (ie., SAML, SMB,… more
- Merck & Co. (Rahway, NJ)
- …FMV/budget issues, obtain business partner input as needed, and provide risk assessments to expedite compliant resolution of complex budget/FMV issues in ... Adhere to SOPs, ethics and departmental compliance as determined by GSBP management as well as our company's guiding corporate policies.-Embrace the philosophy of… more
- Merck & Co. (North Wales, PA)
- …reviews.Lead response to any state PDAB's affordability review of our Company's Oncology products. Model any risk to the business stemming from a state's ... our ability to anticipate changes in the market, prepare accordingly, and mitigate risk so we can continue ensuring appropriate patient access to our Company's… more
- Merck & Co. (Durham, NC)
- …key clients and/or customers to support business needs PEOPLE MANAGEMENT Coaches/mentors direct reports accountable for their area within ... training and project assignmentsManages the area succession plan FINANCIAL MANAGEMENT Assists Engineering & Maintenance Lead with managing the Engineering… more
- Merck & Co. (North Wales, PA)
- …of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, ... / CAPA / Purchasing Controls as it related to 21CFR820. Risk Management experience (ISO 1497124971, ICH Q9).Effective...Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions… more
- Merck & Co. (North Wales, PA)
- …serve as the clinical trial team (CTT) lead. -Leads team for timeline management , risk identification and mitigation, issue resolution.- May facilitate and ... key study planning, development and execution elements (eg, data management deliverables, protocol level plans/timelines, country/site selection, system updates,… more
