- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategies and capabilitiesAdvanced data and analytics including oversight of deployed data scientistsPartner with GOMA functions and lead efforts to advance ... of mutual interestRepresent GOMA on internal digital governance committeesChange management /SMEContinuously monitor the external landscape to identify innovations and… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …goals. The Manager will play a key role in vendor management , contract negotiation, and operational procurement excellence.Key Responsibilities Support and ... lead the execution of Indirect Procurement strategies at the...not limited to:Materials: Lab supplies, PPE, MRO, etc.Services: Facility management , logistics, calibration, waste management , etc.CapEx: Equipment… 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …tracked, archived, searchable and accessible. Enters and tracks project and submission data in Regulatory Information Management system (Vault RIM). With ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… 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)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on...data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software… 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)
- …and inspire accountability- Ethical, resilient, and committed to excellence- Skilled in risk management , team facilitation, and strategic planning- Experience in ... Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Process Improvements, Project Management , Regulatory Submissions, Risk Management ,… 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)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
