- Terumo Medical Corporation (Somerset, NJ)
- …new processes with very little information provided. - Familiarity with relevant regulations, compliance standards, and risk management practices. - Ability ... chain by leading site-specific and regional supplier negotiations and managing projects that lead to cost reductions/avoidances, mitigation of risk , lead … more
- Terumo Medical Corporation (Somerset, NJ)
- …study lifecycle. **Job Details/Responsibilities** Leading the development and execution of Clinical Risk Management Plans and Clinical Quality Plans for studies ... 13485 / 14971, 21 CFR 50/56/812, ICH-GCP, and FDA regulations - Strong auditing and risk management skills. Prior experience with auditing and risk … more
- Terumo Medical Corporation (Somerset, NJ)
- …laws and regulations. Will be responsible for protecting Terumo against legal and compliance risks related to privacy and data management . Additionally, the ... Counsel and Chief Privacy Officer is responsible for managing the privacy, data management , and security program at Terumo Americas Holding, Inc. and certain of its… more
- Terumo Medical Corporation (Somerset, NJ)
- …the integrity of the SAP and Cloud Security Design and uphold the compliance and regulations setup in the application, database and infrastructure layer. This role ... etc). This role will conduct regular security audits and risk assessments such as Segregation of Duties and Critical...Segregation of Duties and Critical Access risks to ensure compliance and mitigate security risks. This individual will design… more
- Terumo Medical Corporation (Somerset, NJ)
- …Perform clinical evaluations. + Assist QS and engineering department in creation of risk management documents and IFU review. + Participate "subject matter ... all activities in accordance with current regulatory and health care compliance guidelines. + Provide high-level research support & investigator-initiated research.… more
- Terumo Medical Corporation (Somerset, NJ)
- …healthcare with heart_** **Job Details/Responsibilities** 1. Strategic Planning and Execution: Lead the development and implementation of short- and long-term ... overall business and marketing objectives. 4. Stakeholder Engagement and Relationship Management : Manage and strengthen relationships with key opinion leaders 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …file is complete and accurate for assigned stud(ies).-Ensure that a study level operational risk management plan is in-place and applies a smart- risk taking ... work in collaboration with the study team and Procurement Management .- Lead trial feasibility and site identification and...philosophy-Responsible for the delivery, oversight, performance and management of 3rd party vendors to ensure … 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role ... sub-teams to develop best practices for global initiatives in validation, quality compliance and material/ raw material support. The validation scope comprises a… 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 III as part of the Quality team based in Raritan, NJ. Role… more
- 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
- Avet Pharmaceuticals Inc (East Brunswick, NJ)
- …to Avet Pharma. This position will focus on the recognition, evaluation, and control of EHS risk at the facilities and the overall compliance of the site to EPA, ... local codes. The position will act as the site lead on EHS measures and work to build a...and work to build a strong culture of EHS compliance at the site to support and protect the… more
- Merck & Co. (Rahway, NJ)
- …Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... and be decisive in an ambiguous environment.Experience and ability to achieve compliance goals through a risk -based approach with a deep understanding… more
- Merck & Co. (Rahway, NJ)
- …point for the docketing team, attorneys, and staffImmediately reports all risk management -related concerns to Senior LeadershipResponsible for the compilation ... Office Suite (Outlook, Word, Excel and SharePoint) and Adobe Acrobat ProStrong project management skills, including the ability to lead and oversee complex… more
- Merck & Co. (Rahway, NJ)
- …, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk Management , Stakeholder ManagementPreferred Skills: Current ... you'll be a core member of the Value Chain Management Team, guiding strategy, ensuring compliance , and...with site quality teamsRepresent Quality on the Value Chain Management Team and related working groups; lead … more
- Formation Bio (New York, NY)
- …with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they ... faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the clinical… 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
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… 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
