- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical and Regulatory (CMR). Essential Functions Facilitates the creation and management of budgets and resource strategies within a VP Functional area of ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...a difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR...side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist… more
- Merck & Co. (Rahway, NJ)
- …potential. The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary. The candidate ... including small molecules and peptides.- Within OFS, the Director will influence the strategy , lead activities, and develop a team whose roles include the design and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …continuous improvement, project management , change and risk management . Responsibilities - Leadership, Direction, and Strategy : Leads implementation of ... veterans and people with disabilities. Summary The Associate Director, External Data Management , is accountable for the end-to-end delivery of External data in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes to regulatory authority requests or ... people with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with… more
- Merck & Co. (North Wales, PA)
- …and how the various functional areas contribute to a comprehensive strategy .Project management certification (PMP) and/or formal coursework/training in project ... Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Development...strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC, commercial, and other areas)… more
- Tris Pharma (Monmouth Junction, NJ)
- …execution obligations Fosters a culture of quality-by-design in trial oversight and risk management across outsourced clinical trials, ensuring efficient issue ... contractors Provides oversight and support to CRO Clinical Operations and Project Management areas ensuring ability to meet clinical, regulatory and business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …continuous improvement, project management , change management , and risk management . ResponsibilitiesLeadership, Direction, and Strategy :Provides data ... project team regarding the data management DM activities and deliverablesEstablishes Data Management strategy at the project and/or study level for a larger… more
- Merck & Co. (North Wales, PA)
- …ready.INSPECTIONS: Responsible for maintaining ongoing inspection readiness for system integration of risk management and central analytics processes as well as ... preparing for, management and follow up of regulatory inspections...monitoring, data management , clinical quality assurance, study management )Experience with risk management tools… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conduct is completed in compliance and meets Novo Nordisk's business standards Risk management : Assessing and mitigating risks associated with operations, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and create efficiencies. Manage end to end supply, order management , placement and delivery to US and CA warehouses… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Department, helping to ensure that the E&CDepartment takes a holistic view of risk management , considering broad organizational priorities as well as external ... Oversees projects across global and North America organization to support the corporate strategy and manage risk of the organization Supports NN affiliates (eg,… more
- Merck & Co. (Rahway, NJ)
- …applying regulatory frameworks and keeping abreast of the changing regulatory landscape.Strong leadership, change execution, and financial management skills ... governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …On-Prem, Service Provider Outsourcing). Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements, industry best practices and ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Merck & Co. (Rahway, NJ)
- …reporting relationship to functional groups in development, quality, safety, facilities management , analytical, finance and regulatory .-FLEx was designed to be ... assets in RY880, RY53, RY53 and RY80B.- This extends from materials management , weigh and dispense, GMP manufacture, formulation development, and bulk Drug Product… more
- Merck & Co. (North Wales, PA)
- …position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across the ... manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, answer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Director, the Associate Manager will support CMR's partnership and alliance contract management strategy with a focus on: Partnering with stakeholders across ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...with business guidance and ethics Identifying opportunities for change management that enhance efficiencies across the contracting life cycle… more
- Merck & Co. (Rahway, NJ)
- …plans, strategy development, launch and marketing execution and budget management .Ensure planning and readiness for senior business and strategy reviews ... input on such activities as: target product profile development, global regulatory filing strategy , labeling, launch readiness reviews, organized customer… more
- Merck & Co. (Rahway, NJ)
- …(including the CTCs, CRAs and COMs).Responsible for creating and executing a local risk management plan for assigned studies.Ensures compliance with CTMS, eTMF ... TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with-ICH/GCP and… more
- Merck & Co. (North Wales, PA)
- …build partnerships and trust with Commercial Legal, Compliance, Privacy and Regulatory colleagues to effectively alleviate concerns and mitigate real/perceived ... risk from never before tried customer engagement capabilities and...US Oncology prioritiesUnderstands the details of the tumor marketing strategy in order to make recommendations for digital solutions… more
