- Terumo Medical Corporation (Somerset, NJ)
- …Corporate Counsel and Chief Privacy Officer is responsible for managing the privacy, data management , and security program at Terumo Americas Holding, Inc. and ... Legal support and advice on company strategies regarding privacy, data management and security and their implementation...lead privacy training programs on privacy matters, including data protection. + Providing legal advice and guidance on… 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)
- …etc. + Extensive knowledge of SAP security concepts, including authorizations, roles, and data access control. + Ability to lead critical issues involving SAP ... and Cloud security policies, procedures, and configurations to protect sensitive access, data and comply with various regulatory requirements (eg GxP, JSOX, etc).… 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 ... Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: Scientific Data & Communication **Job Summary** The Sr. Medical Science Liaison (MSL)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities in collaboration with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical database (edit checks, CCG ... 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues… 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 ... cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes working… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and… more
- Merck & Co. (Rahway, NJ)
- …Intelligence (BI) Desktop, Natural Language Processing (NLP), Python (Programming Language), Risk Management , R Programming, Science, Scientific Literacy, Trade ... to support the R&D efforts related to the Insider Risk /Trade Secret (IR/TS) program through advanced data ...Data Insights, Data Loss Prevention (DLP), Data Visualization, Information Asset Management , Intellectual Property… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …epidemiological data , and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter expert ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …initiatives Work closely with the Director of Strategy and Director of Account Management to align initiatives with strategic goals Lead planning sessions and ... need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential?… more
- Merck & Co. (Rahway, NJ)
- …functions for the electronic Supplier Tracking and Repository System and assist in data maintenance. Lead a team of 8-10 who oversee both internal and ... and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below aspects of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality plans for proactive quality management .Collaborate with the audit function, Data Management teams, MA stakeholders and CROs to ensure high ... access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design,… more
- Merck & Co. (Rahway, NJ)
- …Capital Project Management , Capital Projects, Change Management , Cybersecurity Risk Management , Data Analysis, Deviation Management , Equipment ... start-up operations (FLEx) and new capital builds, including automation lifecycle management , data /analytics, and site representation on capital projects.- Some… 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)
- …Analysis, Malware Analysis, Management Process, Penetration Testing, People Leadership, Risk Management , Security Information and Event Management ... security landscape, utilizing SIEM, EDR, XDR and cloud security platforms. Lead the development and refinement of complex, high-fidelity detection use cases,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …MD, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit- risk ... but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders, with a focus on corporate functions (eg, Procurement; Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier ... contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks within… more
