- Eisai, Inc (Nutley, NJ)
- …assessment.Collaborates with global stakeholders from EIT and leaders across regions in Compliance , Ethics, Risk Management , Legal, Data Privacy, and ... compliance requirements.Oversee business continuity, disaster recovery, and crisis management .Manage IT training programs and conduct Segregation of Duties… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …evaluate and revise the CM plan as necessary.Identify areas of potential non- compliance and assist in the remediation of risk ,Responsible for the ... support the leader in the development and implementation of the Compliance Monitoring Program, specifically Federal healthcare laws, FDA promotional guidelines, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAPA implementation. Indirectly oversee Investigations Managers, providing guidance and support. Risk Assessment and Prioritization: Conduct risk assessments ... based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and… more
- Merck & Co. (Rahway, NJ)
- …standards of ethics and integrity by fostering a culture that promotes ethical conduct and speaking up to report misconduct.- Among other activities, the Ethics team ... is responsible for maintaining the Code of Conduct and the Ethics Ambassador Program, developing ethics... and the Ethics Ambassador Program, developing ethics and compliance training workshops and communications, and managing other key… more
- Novo Nordisk Inc. (Phoenix, AZ)
- …rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership ... identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes… more
- Eisai, Inc (Nutley, NJ)
- …assets.7. Risk assessment and mitigation: Collaborate with the Global Security & Compliance team to conduct regular risk assessments to identify ... will dotted line report into the Global Security & Compliance team (second line of defense). The primary objective...role will be required to provide input into vulnerability management , risk management , security architect,… more
- Merck & Co. (Rahway, NJ)
- …and worldwide Regulatory Health Authority requirements.Experience with delivering effective CAPA management solutions.Experience with risk management tools ... real-time, proactive advice and guidance. Escalate potentially significant inspection findings/ compliance risks/impact to our Company Senior Management . Develops… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …has strong skills in continuous improvement, project management , change management , and risk management . ResponsibilitiesLeadership, Direction, and ... with greater complexity.May manage Data Management full-time and/or contract staff.Project Management :Plans and directs the conduct of Data Management … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance . Takes ownership to deliver upon near-term North America Clinical ... with established targets and including communication of updates Ensures proactive risk identification and mitigation planning for assigned clinical trial sites… more
- Merck & Co. (Rahway, NJ)
- …data.Assist in the development and implementation of EHS programs and policies. Conduct risk assessments, incident investigations, and audits as needed.Ensure ... gather, analyze, and visualize data, enabling evidence-based decision-making and ensuring compliance with EHS regulations. You will work closely with various… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …completed in compliance and meets Novo Nordisk's business standards Risk management : Assessing and mitigating risks associated with operations, implementing ... to decrease costs and create efficiencies. Manage end to end supply, order management , placement and delivery to US and CA warehouses operations for US and… more
- Merck & Co. (Rahway, NJ)
- …site relationships through all-phases of the trial.Performs clinical study site management /monitoring activities in compliance with ICH-GCP,-Sponsor SOPs, Local ... Investigators and site staff on issues related to protocol conduct ,-recruitment, retention, protocol deviations, regulatory documentation, site-audits/inspections and overall… more
- Merck & Co. (Rahway, NJ)
- …site relationships through all phases of the trial.Performs clinical study site management /monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local ... Investigators and site staff on issues related to protocol conduct , recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections… more
- Merck & Co. (Rahway, NJ)
- Job Description Portfolio Customer Experience Execution & Day-to-Day Management : Develop guidance and tools to scale tumor team franchise strategies across multiple ... products Execute GRL interviews to begin change management process and support buy-in Own day-to-day execution with...other quick win tactics (eg, omnichannel suite of templates) Conduct L3 Next for our Company's Portfolio focused on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with responsibility for clinical study plan and execution (from planning start-up, conduct , reporting and close out) including timeline, quality and budget. A key ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Merck & Co. (Millsboro, DE)
- …at our company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as applicable to the ... of the Site Leadership Team and is responsible for the management and leadership of the Animal Services Department.Essential Duties / ResponsibilitiesAssociate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …has moderate skills in continuous improvement, project management , change management , and risk management . ResponsibilitiesLeadership, Direction, and ... at the project and/or study level for a smaller number of projects/studiesProject Management :Plans and directs the conduct of Data Management activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally ... the role of both operational strategy and study execution. ResponsibilitiesStudy Management & Leadership Has primary accountability for operational study level time,… more
- Merck & Co. (Rahway, NJ)
- …along with the global teams to develop options and alternative solutions.Category management ensuring compliance to the procurement process and supporting the ... RFP, e-sourcing, Supplier onboarding, Due Diligence, Negotiation, Contracting).Lead and conduct project progress meetings with stakeholders and partners (External)Stakeholder… more
