- 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
- Russell Tobin & Associates (Dublin, OH)
- …municipal officials, engineers, developers, and contractors Lead or assist in the development of strategy , the scope of work, evaluation of risk , and budget for ... work assignments to internal project teams and subcontractors Interact with regulatory agencies knowing what information to provide, when, and with appropriate… more
- Russell Tobin & Associates (Dublin, OH)
- …municipal officials, engineers, developers, and contractors Lead or assist in the development of strategy , the scope of work, evaluation of risk , and budget for ... work assignments to internal project teams and subcontractors Interact with regulatory agencies knowing what information to provide, when, and with appropriate… more
- Merck & Co. (Rahway, NJ)
- …for process and technology solutions, timeline creation, resource assessment, risk management , Estimation, budget development, etc.Communicate and escalate ... Job DescriptionAs a Project Manager within the Strategy Realization Office (SRO) function of GMSA at our company, the successful applicant will play a critical role… more
- Merck & Co. (Rahway, NJ)
- …pro ducts to meet specific goals and objectives , including resource allocation, risk management , and portfolio optimization. - Develops and regularly calibrates ... the "Business") in areas such as Privacy and Policy Management . The Technical Product Manager is a key...the organization. - Defines the overall product vision and strategy , emphasizing value, business outcome, and user experience. -… more
- American Honda Motor Co Inc (Marysville, OH)
- …transactional matters, the Deputy General Counsel will develop recommendations regarding matter strategy , risk assessment, and legal compliance with support from ... an attorney in commercial contracts* Proven knowledge of contractual, regulatory , and commercial lawOther Job-Specific Skills* Preferred: 5 -...the Sr. Manager, Compliance, Risk , and Law. Advising executives and management … 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
- Eisai, Inc (Nutley, NJ)
- …study teams; Supporting Safety processes, such as Case in-take, Case processing, Risk management and Safety reporting; Business Intelligence technologies such as ... Regulatory and/or Safety functions in a global environment; Supporting Regulatory processes such as Submissions Management , Labelling, Publishing and… 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)
- …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
- Merck & Co. (Rahway, NJ)
- …will need will collaborate with cross-functional teams, including development, product management , and quality assurance, to ensure the successful delivery of ... software solutions.Responsibilities: Develop and implement an effective validation and testing strategy for the platform team, in line with industry best practices… 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
- 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)
- …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
- 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
- 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
- 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)
- …improvement, project management , change management , and risk management . ResponsibilitiesLeadership, Direction, and Strategy :Establishes Data ... and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… 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
