- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and analytics.Conduct analysis to identify business needs across GRA sub -functionsTranslate business requirements into technical specifications and data models to ... solutions to meet GRA needs and enable visibility across regions and sub -functionsPartner with the Process Excellence Lead and others to identify process… more
- Inova Health System (Falls Church, VA)
- …techniques. Provides medical physics coverage as deemed appropriate to the sub specialty.(ie Radiation Therapy, Cardiac Cath.). Oversees acceptance testing of new ... radiation.- Provides Medical Physics coverage as deemed appropriate to the sub specialty (ie Radiation Therapy, Cardiac Cath.).- Confers with engineering concerning… more
- Toyota Boshoku (Hopkinsville, KY)
- …Practices (TBBP) to ensure all aspects of manufacturing are effective and correct sub -standard situations. 5. Perform the essential job functions of team leaders or ... leaders and/or team members, assuring training is effective and corrects sub -standard performance. 3. Maintain, plan, and prepare department instruction manuals. 4.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …recall programs, . This position interacts with Quality Assurance (QA) sub -functional and cross-functional teams, as well as Contract Manufacturing Organization ... (CMO) leading a productive working relationship with internal/external stakeholders acting as partner to successfully drive commercial and IMP deliverables as appropriate.ResponsibilitiesDrug Product Release: Manages the execution of assigned responsibilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the various cross-functional forums including, Publications Planning, Clinical and Safety sub -teams, US and Global Brand Team, and US Product Team to inform ... clinical development, commercialization, market access, and other cross-functional strategic discussions. - Provides medical leadership: Leads USOMA teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub - PI's, nurses) at the site level to ensure that patient safety with ... respect to the safety risk assigned remains top of mind in the context of patient management in the clinical trial setting and in the real-world setting.Contributes to creation and improvement of Clinical Development processes. Education:MD required; prefer… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Effectively represent the CSPV on the Global Product Team or specific sub -teams such as clinical study team and submission team, providing the safety ... leadership and serving as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals. Review and evaluate serious adverse event reports from clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …plans which include market research and integrated analytics (national and sub -national) across patient, physician and partnering on payor / provider customers ... Champion the implementation of agile, innovative and/or best practice market research and analytics tools, methods and approaches in order to increase timeliness, improve agility, and build competitive advantage Demonstrate leadership in insight… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …plans which include market research and integrated analytics (national and sub -national) across patient, physician and partnering on payor / provider customers ... Champion the implementation of agile, innovative and/or best practice market research and analytics tools, methods and approaches in order to increase timeliness, improve agility, and build competitive advantage Demonstrate leadership in insight… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …plans which include marketing research and integrated analytics (national and sub -national) across patient, physician and partnering on payor / provider customers ... Champion the implementation of agile, innovative and/or best practice market research and analytics tools, methods and approaches in order to increase timeliness, improve agility, and build competitive advantage Demonstrate leadership in insight… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Enabling Functions with developing business requirements across a specific category/ sub -category Benchmarks operational costs to industry standards and provides ... information and insights to the lines of business Develops supplier selection criteria and facilitate team members through a disciplined strategic sourcing process focused on maximizing total value Dialogues with suppliers to ensure optimal relationship with… more
- Insmed Incorporated (San Diego, CA)
- …leads to develop high quality, integrated, cross-functional plans for cross-functional sub -teams that are aligned with the overall program strategy; Visualize ... timelines in succinct and impactful ways to support communication, scenario planning, and decision-making Act as an integrator within functional and cross-functional teams and highlight interdependencies and downstream impacts of strategic decisions Ensures… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience in one or more clinical trial operations functions / sub -functions (Data Management, Biostatistics, Clinical Science) preferred Travel:Ability to travel ... up to 5% For team/global meetings, conferences and to support inspections. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plan.Partners with the Clinical Team Leader to ensure a high performing Clinical Sub -team and to drive the development and delivery of the clinical development plan ... in alignment with the product development strategy.Manages the team meetings including developing the agendas and documenting decisions and action items. Identifies organizational gaps and influences the project environment to address gaps that impact the… more
- Insmed Incorporated (San Diego, CA)
- …forms, study guidelines, operations manuals, training materials.Leads Clinical Sub -team meetings.Approves action plans to address protocol compliance, safety, ... data and administrative issues with investigational sites and CROs.Job Requirements:Bachelor's degree required. Advanced degree preferred.Minimum of 10 years managing clinical trials at a Sponsor company.Experience managing various phases of clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub -team and G-RA teams along with other functional teams leading to sound ... scientific development programs and successful registration for new compounds. Performs collaborative authoring with other RACMC regional team members and subject matter experts for Health Authority (HA) submission, HA meetings, and responses to HA queries.… more
- Eisai, Inc (Nutley, NJ)
- …and strategic initiatives.Builds relationships with stakeholders.Directs projects or sub teams as needed to execute objectives.Proactively identifies and ... resolves issues.Business Analysis & Project ManagementFacilitates the communication and translation of business user requirements and solutions between the customer community (internal and external customers) and internal ITDiagnoses problems and understands… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as part of the Project Management Office and Business Excellence (PMOBE) sub -function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic ... planning and implementation group within CSPV that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process optimizations and drives key operational activities to enhance global team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to identify suitable mechanistic elements, interactions, rate constants and sub -modules for incorporation into systems (disease) modelsContribute to the design, ... execution and interpretation of clinical and non-clinical studies.Partner with external groups to accelerate and supplement the internal QSP efforts in key disease indicationsMaintain effective collaboration with internal/external stakeholders across diverse… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 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… more
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