- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for ... leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU...documents; Maintains and tracks labeling documents in the electronic system as appropriate.Participates in the development and maintenance of… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the ... to the Executive Director, IT Security, Compliance, & Architecture, s/he is the Global IT department's trusted leader and manager who assesses and provides objective… more
- Merck & Co. (North Wales, PA)
- …in development or commercial products.In depth knowledge and application of global CMC guidelines regarding IND/BLAs or post approval changes.The CMC Project ... for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change documentation… more
- Eisai, Inc (Raleigh, NC)
- …and third-party systems , as needed.Assist in managing the Global Serialization Enterprise System , including overseeing changes, monitoring performance, ... Global Serialization Associate will serve as a super-user of Eisai's Global Serialization Enterprise system (rfXcel), working directly with users and acting… more
- Eisai, Inc (Raleigh, NC)
- …If this is your profile, we want to hear from you.The Project Manager, Global Supply Chain is responsible for supply related projects and global launch ... preparations for products within Eisai Demand Chain Systems (EDCS). This individual will create, maintain, and monitor supply chain related projects and/or closely… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes, and business systems requirements. Accountable for global systems implementations inclusive of migrating from one system to another. This ... advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors).Lead respective workstream(s) to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... diseases and immune disorders. We are currently seeking a Global Internal Audit Intern for the year (June 2025...with a concentration in Accounting, Finance, Computer Science, Information Systems or related field. Prior experience in a corporate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... rare diseases and immune disorders. Summary This position will be part of the Global Compliance & Risk Management organization and will report directly to the Head… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …IT and external resources to ensure the optimal performance and integration of legal systems Troubleshoot system issues and provide user support as needed Review ... office dedicated time. EST time zone hours. The Position Will focus on legal systems , training, and knowledge management and play a pivotal role in ensuring the… more
- Merck & Co. (North Wales, PA)
- …of medical drugs and vaccines for the benefit of patients and global human healthPrimary Responsibilities:Develop and validate global programming standards and ... or related field with a minimum of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.MS (preferred) in Computer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... responsible for overseeing the development, implementation, and maintenance of software systems that support business operations and objectives, with a special… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manner. They will assist in the operation and governance of iEnvision, an internal global publications database system , as well as help develop needed training ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi... Oncology Medical Affairs (GOMA) is seeking a Publications Systems and Operations Intern to work closely with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... position is accountable for comprehensive Payroll Management with a focus on Systems and Process Enhancements/Innovation and relies on deep expertise in payroll… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implementation within the organization. This role ensures that all non-regulated global corporate systems , regional/ global websites, portals, process ... will define and drive the methodology, approach, and best practices for non-GxP systems , ensuring alignment with the Global Digital Transformation (DX) and User… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... vendors. This position is also responsible for the delivery of systems , configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to execute regulatory-compliant computer system validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation ... areas centered around rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects... supporting GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …solving complex issues and reducing toil. We want you to be part of our global team which focuses on making it easier for modern applications host their application ... job responsibilities include:Contributes to architecture, design, and engineering of global - Kubernetes -Platform and Cluster Management service.Contributes to architecture,… more
- Merck & Co. (Durham, NC)
- …ensure GxP compliance. Drive resolution of regulatory non-conformance for GxP computerized systems . Assure monitoring of system health, compliance and other ... Digital & Data Quality management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including vendor outsourcing agreements, PV… more
