• Insmed Incorporated (Bridgewater, NJ)
    …validation practices and EDMS/QMS system requirements and workflows.Lead GxP IT Change Control cross functional subject matter expert forum assessing GxP ... following: Represent Digital Systems QA as a GxP computer system validation expert and provide oversight and guidance on computer systems validation in accordance… more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …from sites/ Institutional Review Boards (IRBs), and other site personnel as needed.Study-specific subject matter expert (SME) for internal audit or Health ... demonstrated decision-making capabilities. Provides medical and scientific expertise to cross- functional DSI colleagues.ResponsibilitiesMedical MonitoringFor studies in which Medical Monitoring… more
    HireLifeScience (03/07/24)
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  • George Washington University (Washington, DC)
    …cohesive team, takes independent initiative to achieve program objectives, and can become a subject matter expert within the team. Experience working with ... and complex operational questions from faculty, staff, and students, and provide functional support and management for GWSB Operations. Functional support could… more
    JobGet (03/07/24)
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  • Computer World Services (CWS)Corporation (Washington, DC)
    …best practices, and industry trends to drive continuous improvement. * Serve as a subject matter expert on ServiceNow capabilities, providing guidance on ... and enhance operational efficiency. You will collaborate closely with cross- functional teams, including IT operations, business analysts, and stakeholders, to… more
    JobGet (03/02/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …(LTF) for North America Operations (NAO). The process relies on collaboration with cross- functional subject matter experts, high level of market ... strong collaborator with NNI and Global stakeholders Seen as subject matter expert within field...of relevant experience may be substituted for advanced degree Functional expert using at least one of… more
    HireLifeScience (02/27/24)
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  • Merck & Co. (Rahway, NJ)
    …participation as topic team member and/or subject matter expert . Represent Development Quality on inter-departmental and cross- functional teams, ensuring ... CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter expert . Proactive identify, execute and manage… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    …enterprise.- As part of a small, central team, the individual will serve as a subject matter expert in business continuity across engagements with a variety ... matter experts to support prioritized processes and products.Serve as a subject matter expert throughout the BC lifecycle, including business impact… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    …of the strategic elements of drug development and effective communication skills. As a subject matter expert , the Associate Director within the QP2-IO Group ... will work closely with teams of highly collaborative, cross- functional scientists to contribute to development of novel chemical entities. They develop strategies… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (North Wales, PA)
    …launch plans while leveraging agile strategies and methods. Serve as a launch excellence subject matter expert . Bring novel ideas to launch readiness across ... aligns with brand strategy. Track progress and identify risks and cross- functional interdependencies across all launch workstreams. Lead scenario planning, risk… more
    HireLifeScience (03/19/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …access trends, hub program utilization, and performance against defined KPIs Function as subject matter expert on Rare Disease patient reimbursement support ... auditing and active call monitoring Ensure strong collaboration with relevant cross- functional stakeholders Develop and maintain SOPs and business rules related to… more
    HireLifeScience (03/27/24)
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  • Eisai, Inc (Nutley, NJ)
    …input into the lifecycle management strategies in responsible therapeutic areas. Medical/Scientific subject matter expert : Serve as medical leader and ... Affairs Strategic Plans: Work with key stakeholders, management, and functional area leads to develop strategic and aligned Medical... subject matter expert providing direction for assigned products… more
    HireLifeScience (02/14/24)
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  • Merck & Co. (Rahway, NJ)
    …Lead The Associate Director, Global Clinical Data Standards Therapeutic Area (GCDS TA)-Lead is a subject matter expert in the area of data standards as it ... of clinical data standards.-Led or participate in department initiatives, cross- functional working groups and process improvement activities.Participate in cross-… more
    HireLifeScience (03/22/24)
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  • Novo Nordisk Inc. (Chicago, IL)
    …ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and competency of the ... conditions and areas of opportunity aligned with Therapeutic Area priorities Utilizes subject matter expertise and analytical tools to provide deeper customer… more
    HireLifeScience (03/20/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …processes for labeling development and review, and resourcing that incorporates input from cross- functional subject matter experts and senior leadership at ... global, regional and local products. They also support labeling activities and provide expert guidance for labels in all markets where Daiichi Sankyo operates. This… more
    HireLifeScience (02/23/24)
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  • Eisai, Inc (Nutley, NJ)
    …input into the lifecycle management strategies in responsible therapeutic areas. 1 0%Medical/Scientific subject matter expert : Serve as medical leader and ... Director, work with key stakeholders, alliance counterparts, management, and functional area leads to develop strategic and aligned Medical...subject matter expert providing direction for assigned products… more
    HireLifeScience (01/25/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …organization, support effective communication and collaboration between DAST members and other functional stakeholders & subject matter experts, and support ... and development. This role will lead workstreams with highly matrixed cross- functional and cross-regional teams. Stakeholders include many functions within R&D and… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (North Wales, PA)
    …including assignment of resources, professional-development, and performance management.May serve as a subject matter expert and/or participate on process ... the Program Lead, you will collaborate with global, cross- functional team-members including clinical directors and study managers to...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Affairs Team (GMAT, or Joint Medical Affairs Team for Alliance compounds) and as a subject matter expert (SME), in alignment with the GMAT Lead, develop ... and lead the implementation across the asset teams.- Provide functional excellence expert support and coaching to junior EG team members. Qualifications:… more
    HireLifeScience (02/23/24)
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  • Lundbeck (WA)
    …Senior Manager, State Policy and Strategy position is responsible for serving as the internal subject matter expert for matters related to the state policy ... bring awareness of business-critical issues for informed decision making, and work with subject matter experts within the company to assess impact on Lundbeck's… more
    HireLifeScience (01/20/24)
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  • Exela Pharma Sciences, LLC (Lenoir, NC)
    …execution of root cause analysis through SWOT, FMEA, etc.Serve as Quality subject matter expert concerning Engineering/Validation activities.Represent the ... contact with the FDA and other regulatory agency audits Consult with subject matter experts and/or functional area managers for technical supervision and… more
    HireLifeScience (02/08/24)
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