- Legend Biotech USA, Inc. (Raritan, NJ)
- …combines deep expertise in CAR-T process technologies with a strong focus on compliance auditing, risk assessment, and continuous improvement.The Compliance ... in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Rahway, NJ)
- …GCP Guidelines, Management Process, Medical Writing, Process Improvements, Regulatory Compliance , Risk Management, Social Collaboration, Strategic Planning, ... to implement `quality by design` within clinical development programs, using a risk -based approach.The incumbent will be accountable for the overall strategy for… more
- Merck & Co. (Rahway, NJ)
- …Regulatory Compliance , Pharmacovigilance, Pharmacy Regulation, Prioritization, Regulatory Compliance , Regulatory Reporting, Risk Communications, Risk ... which the Senior Specialist is responsiblePV Statement preparation in compliance with relevant regulations, policies, and proceduresSame/similar designation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …culture of collaboration, innovation, and continuous improvement within the team. Compliance and Risk Management:Proactively identify potential regulatory risks ... risk assessments and provide actionable recommendations to mitigate compliance risks.Provide training and guidance to internal teams on regulatory requirements… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk .Ability to collaborate well with stakeholders, ... responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and ... during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards,… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Manager of Treasury and Risk Management monitors and updates various cash flows and procedures, including domestic and ... debt and investment instruments. The Manager of Treasury and Risk Management assumes responsibility for corporate cashiering, accounts-receivable deposits,… more
- Merck & Co. (North Wales, PA)
- …Project Management, Project Planning, Project Scheduling, Project Strategy, Regulatory Compliance , Results-Oriented, Risk Management, Software Project Management ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… 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 ... procurement policies, procedures, and governance frameworks to ensure consistency, compliance , and cost discipline. Collaborate with finance, legal, R&D, and… more
- Merck & Co. (Rahway, NJ)
- …and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images ... management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise wide ... shooting and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external… more
- Merck & Co. (Rahway, NJ)
- …and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images ... management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of continuous improvement in ... benefit- risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual...monitoring and tracking of the signal workflow to ensure compliance with procedural documents.When required, assist the product safety… more
- Merck & Co. (Rahway, NJ)
- … compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the development ... with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive experience in design controls,… more
- Merck & Co. (Rahway, NJ)
- … compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the development ... with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic Leadership and Project Management: Provide… more
- Merck & Co. (Rahway, NJ)
- …Device Development and with external suppliers. Understand and apply regulatory / compliance requirements relative to design controls and risk management ... and statistical skills with experience in data interpretation and risk assessment tools. Excellent communication, leadership, and problem-solving skills. Ability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identified during internal systems audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory ... of GxP audits assigned in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned with the company's strategy and… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and detect critical flaws including ability to determine areas of potential risk , generate gap analysis and mitigation strategies In-depth knowledge of global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the ... programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... detect critical flaws including ability to determine areas of potential risk , generate gap analysis and mitigation strategiesIn-depth knowledge of global regulatory… more
