- Merck & Co. (Rahway, NJ)
- …experts within the broader DD&T team (eg design verification, device risk management , human factors, technical integration, assembly automation, etc.), ... development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Merck & Co. (Rahway, NJ)
- …and inspire accountabilityEthical, resilient, and committed to excellenceSkilled in risk management , team facilitation, and strategic planningExperience in ... Process Characterization, Process Control, Process Design, Process Optimization, Regulatory Submissions, Risk Consulting, Risk Management , Science {+ 4… more
- Merck & Co. (Rahway, NJ)
- …activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject ... Control, Process Improvements, Quality Assurance (QA), Quality Assurance Systems, Quality Risk Management , Technical Writing, Test and Evaluation (T&E),… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also assist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and managing ... rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function… more
- Merck & Co. (Rahway, NJ)
- …E, Reg Z, PCI DSS, and FFIEC guidelines.Champion the credit union's enterprise risk management strategy of "Slow Down, Stop, Escalate"Team LeadershipLead and ... and track KPIs for performance, member experience, and operational efficiency. Risk & ComplianceMaintain strong controls and procedures to comply with… more
- Merck & Co. (Rahway, NJ)
- …and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program ... and design controls for the assigned projects while adhering to management -approved strategic plans, corporate policies, and providing clear communication to… more
- Merck & Co. (San Francisco, CA)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug… more
- Novo Nordisk Inc. (Durham, NC)
- …and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... assignments within compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate cLEAN® tools when relevant Lead… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to work ... has deep experience in procurement, strategic sourcing, and vendor management within the biotech, pharmaceutical, or life sciences industry.Responsibilities Develop… more
- Merck & Co. (Rahway, NJ)
- …-The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. ... following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).-… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate ... Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management of staff in a growing operation in terms of volume/output… more
- Aequor (Thousand Oaks, CA)
- …and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management , and leading matrixed teams through influence to meet NPI ... cross-functional projects to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of the immediate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with ... of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process… 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
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... Management (Legal/ Compliance)Eisai Salary Transparency Language:The base salary range for the Associate Senior Counsel, Market Access is from :189,100-248,200Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... to advance ADC, Complex Biologics and Small molecule portfolio.Project management skillsAttention to technical detailBuilds collaborations across internal our… more
- Novo Nordisk Inc. (Olathe, KS)
- …the treatment of diabetes Appropriately present the Standards of Care for diabetes, including management of CV risk in patients with type 2 diabetes, to educate ... risks Effectively present the Standards of Care for cardiovascular disease, highlighting the management of cardiovascular risk in patients with type 2 diabetes… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory ... experience strongly preferred, and experience with IT System/Business System Management .Education Min. Requirement: BS/BA or an equivalent certification/experience in… more
- Merck & Co. (Durham, NC)
- …individual and has the ability to communicate effectively with senior management on complex technical issues and manage multiple high-priority, complex ... environmental, health, safety, and sustainability (EHS&S) opportunities.- Ensure comprehensive change management of all EHS and Site initiatives to ensure ongoing… more
