- Novo Nordisk Inc. (Plainsboro, NJ)
- …with us? The Position The purpose of the Peer to Peer Tech & Innovation Associate is to assist in the management and optimization of the Peer-to-Peer HCP engagement ... to improve the accuracy and timeliness of HCP engagement records. The associate will support efforts to adapt and optimize systems, implement new technologies,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Associate Director, Research Partnerships (RP) is responsible for developing...RWE generation and dissemination through research partnerships Ensure the quality and validity of real-world evidence and ensure that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position The Associate Manager of Technical Production will be responsible for overseeing the technical aspects ... to ensure that all video productions meet the highest standards of technical quality , efficiency, and reliability. Relationship This job reports to a Director in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director, HCP Experience has overall strategic and operational responsibility as well ... brands. Relationships Reports to the Hemophilia Therapy Area Lead. Works closely with Associate Directors and Sr Brand Managers across the Rare Bleeding TA and with… more
- Genmab (Plainsboro, NJ)
- …and utilized at a pace never seen before. Join Genmab as an Associate Director, Solution Architecture and Engineering, R&D Digital Products as part of our ... Agile methodologies and ensure standards are met for test automation, quality , performance, security, and compliance.Stay current on leading practices and modern… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and budgets to ensure that vendors deliver services within scope, schedule, quality , and budget estimates. Reviews and evaluates vendor performance against KPIs and ... applying expert knowledge of compliance with all security, regulatory, and quality policies and procedures, ensuring compliance with change management and validation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …planning and execution to assigned Novo Nordisk, Inc. therapeutic areas. Assist Associate Director with development and execution of annual strategic convention plan ... Relationships Reports to the Manager, Convention Marketing reports to the Associate Director, Convention Marketing of the Strategic Meeting & Event Management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Strategic Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating and monitoring ... improvements and seek agreement through consensus management. Relationships Reports to an Associate Director / Director within the NNI Procurement Team and will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key internal and external stakeholders ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, ... of drug products for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best ... practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination: Builds cross-functional and cross-regional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.Qualifications: Successful candidates will be ... able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)Bachelor's Degree Science degree requiredMaster's Degree preferred orPharmD preferred orRN degree preferred… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple aspects of the ... development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior ... CMC Lead regarding the activity status and potential critical issues, or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the ... development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT functions at Daiichi Sankyo. As a trusted partner, provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and ManagementManaging ... all data requests, perform self-QC of data to ensure quality of results. Service Provider Oversight & ManagementOversight of...usual.Leads or assists in the tracking and investigation of quality and compliance issues OtherReview and update of DMA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping ... to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to design optimal processes and sourcing solutions that meet the business' objectives and produce synergies… more
