- 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
- 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
- Novo Nordisk Inc. (Miami, FL)
- …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
- 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
- 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
- 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)
- …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)
- …sample testing) in line with the established quality standards and timelines. Conduct IT policy compliance , system implementation, network security, ... Corporate Audit and Assurance Services' (MCAAS) provides value-added independent and risk based audit, assurance and advisory services.Position Overview Function and… 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)
- …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
- 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)
- …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)
- …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
- 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)
- …in their assigned customer groups in alignment with the sales management team and commercial operations groups.--Additionally, this position will stay abreast ... process.--They must also align with our Distribution, Marketing and Channel Management teams. This position must possess negotiation skills, financial acumen, a… more
- Merck & Co. (Rahway, NJ)
- …candidate will have a good understanding of IT financial planning and management processes and the ability to connect requirements from different groups through ... and other standard financial toolsAd-hoc initiatives to support operational financial management of the platform budget and forecastStrong partnership and alignment… 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
- Catalent (St. Petersburg, FL)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. The ... be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required actions are...Work actively with the Catalent sites to manage and conduct Pre-Audit Preparation activities with an understanding of requesting… 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
