- Merck & Co. (Rahway, NJ)
- …operations to achieve those objectives. -Under the guidance of the Regional Director , Clinical Quality Management (RCQM), and in collaboration with the ... Director (s), the Sr CCQM Lead establishes and/or - local clinical Quality Management System (CCQMs) aiming to achieve the organizational strategic goals… more
- Novo Nordisk Inc. (Boston, MA)
- …need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential? ... prescription benefit plans. Customer channels and specific customers include strategic, regional and local health plans, PBMs, State Government entities and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Deliver methods for risk areas/process improvement to stakeholders via the QMS scheme (ie, Quality Management Review, Quality Review Board) across the global ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports... management in close collaboration with the organization's quality management system, to assure robust knowledge… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …across the RA function globally and interacts across functional as well as regional areas. This position often works with ambiguity and complex problems, focusing on ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as… more
- Merck & Co. (Rahway, NJ)
- …focused on meeting business needs and maximizing value for investments.Organizational Change Management : Demonstrate and drive high- quality change management ... animal species. About the Position The Animal Health IT Customer Master Data Management (MDM) Product Owner collaborates with stakeholders across all levels of the… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Associate Director , Strategic Content Development, Global Medical Affairs - Alzheimer's Disease, in the ... publication and medical education initiatives, as well as ensure global- regional , and cross-functional alignment and collaboration with all stakeholders. Under… more
- Merck & Co. (Rahway, NJ)
- …understand information governance needs and propose solutions for information governance, data quality , reference data management , data governance and metadata ... with configurable solutions.Build and review requirements for information governance, data quality , metadata management , and reference data management … more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the ... for phase I-IV global clinical trials including functional services.Accountable for vendor management ; providing guidance to study teams on vendor selection and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and to optimize resourcesDepartment Coordination: Builds cross-functional and cross- regional relationships.People Management : Mentor, develop and managed ... Labeling Operations & Compliance group and across the cross-functional and cross- regional representatives on the labeling review teams as well as with business… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... business. You oversee business continuity, disaster recovery, and crisis management , while also educating end-users on compliance requirements. Additionally, you… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas Infrastructure Director , your role involves collaborating with other Eisai regions and global Enterprise ... Security, and provide leadership to managed services vendors. Organizational management responsibilities include resource prioritization, alignment with the CIO… 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 Position provides field coaching, mentorship and management to the field-based Medical Liaisons, and develops and implements strategies:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the...of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational ... and the business users to define user information needs.Provide informatics project management , SDLC Quality Model expertise, and computer system validation… more
- Eisai, Inc (Nutley, NJ)
- …assessment of Eisai Neurology products, and will be responsible to deliver high quality and impactful models to ensure optimal patient access. In addition, the ... incumbent will ensure quality is maintained in all aspects of technical work...of staff. Some travel may be required for project management and/or business development.The incumbent is expected to be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions to meet smooth ... transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support of these objectives. This position will report to the Sr. Director , Management Office & Business Excellence in CSPV.ResponsibilitiesProject Management ... diseases and immune disorders. SummaryThis position is responsible for supporting project management and operational activities as part of the Project Management … more
- Merck & Co. (Rahway, NJ)
- …CRA (Clinical Research Associate) manager and/or functional vendor and internal management as-needed.Performs Quality control visits as required.Leads local ... as needed different challenges and issues to TA Head/CRD Clinical Research Director /CCQM Country Clinical Quality Manager and or CTT Clinical Trial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally ... is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require… more
