- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the material content of any documents sent to regulatory authorities. Provides compliance metrics to management , as needed. Lead continuous improvement ... to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance...epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, ... Process for the respective business areas.Responsibilities:Leadership and Project Management : Lead the end-to-end quality execution across Medical Affairs… more
- 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 ... lead investigations to ensure process integrity and GMP compliance . Additionally, the role includes overseeing and enhancing manufacturing standards,… 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 ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- …design, global filing and launch strategy, long-range demand vs capacity planning, integrated risk management , cost of goods projections, post approval change ... process and method technical changes, robustness/quality/ productivity projects. Manage product supply risk through Integrated Risk Management (IRM) and… more
- Genscript USA Inc. (Piscataway, NJ)
- …and background. This position is based fully onsite in Piscataway, NJ. Responsibilities: Lead and manage all EHS compliance activities and initiatives for the ... for developing, implementing, and managing site-specific EHS programs and ensuring compliance with local, state, and federal regulations. The ideal candidate will… more
- Eisai, Inc (Nutley, NJ)
- …is 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 ... favorable debt and investment instruments. The Manager of Treasury and Risk Management assumes responsibility for corporate cashiering, accounts-receivable… more
- Merck & Co. (Rahway, NJ)
- …and resolve anomaliesEnsure compliance with all corporate and departmental IT risk management policies and practicesTechnology Management Design and ... Migrations, Deal Management , Detail-Oriented, Generative AI, Information Systems Management , Information Technology (IT) Risk Management , Intellectual… more
- Merck & Co. (Rahway, NJ)
- …operationsNew Products including supply chain design, operations and/or planning - Risk Management and Business/Financial acumenGreen Belt or Black BeltRequired ... New Product Introduction (NPI), New Product Introduction Process, Operation Risk Management , Pharmaceutical Management , Pharmaceutical Manufacturing,… 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 ... to issues, and demonstrated passion for creating new medicines.Leadership & People Management : Proven ability to lead cross-functional teams, manage performance,… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- Merck & Co. (Rahway, NJ)
- …government relations pertaining to safety and environmental protection and initiate appropriate action. Lead site and/or local area audits for compliance with ... CSP, PE or other related professional certification.#eligableforerpVETJOBSRequired Skills: Budget Management , Budget Management , EHS Compliance , EHS… more
- Merck & Co. (Rahway, NJ)
- …Electronic Common Technical Document (eCTD), Executive Business Management , Immunochemistry, Influence, Innovation, Interpersonal Relationships, Manufacturing ... industry and FDA connections to our company. They will lead a team of CMC professionals, ensuring rigorous CMC...Compliance , Mentoring Staff, People Management , Pharmaceutical Management , Professional Networking, Regulatory Communications,… 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 ... blisters) meet safety, efficacy, quality, and robust supply standards. Drive proactive risk management activities, including risk assessment, risk… more
- Merck & Co. (Rahway, NJ)
- …its customers, and shareholders. The scope of this group includes strategic program management , enterprise strategic planning, risk management , as well as ... Commercial Acumen, Communication, Data-Driven Decision Making, Developing Proposals, Enterprise Risk Management (ERM), Environmental Scanning, Influencing Skills,… more
- Eisai, Inc (Nutley, NJ)
- … Risk Management , Mentoring/ People Development, Stakeholder Management (Legal/ Compliance )Eisai Salary Transparency Language:The base salary range ... logs and HCP payment records Serve as the operational lead for Eisai US's Compliance Monitoring Program,...trends, regulatory changes, and program enhancements C ontribute to compliance RAMP ( Risk Assessment and Mitigation Plan)… 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 ... exploring alternative ways to view and solve problems to achieve results. Drive proactive risk management activities, including risk assessment, risk … more
- Merck & Co. (Rahway, NJ)
- …Packaging Optimization, Packaging Processes, Pharmaceutical Development, Pharmaceutical Packaging, Risk Management , Technical LeadershipPreferred Skills: Current ... understanding and reduction prior to product launch. The packaging development lead will be accountable for technical risk assessments, packaging… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management /change control and quality systems.Experience with FMEA and risk assessment tools.Experience with user requirement documentation and factory/site ... including but not limited to Operations, MSAT, Facilities, C&Q, Project Management , and Quality.Work closely with Sr. Manager, Strategic Initiatives to support… more
- Merck & Co. (Rahway, NJ)
- …Planning, Project Management , Project Procurement Management , Regulatory Compliance , Risk Management , Strategic Procurement {+ 5 more}Preferred ... and category strategy alignment, sourcing and contracting execution, contract and claims management , project and risk management practices, and supplier… more
