- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the creation of automated, scalable approaches for data quality issue identification, support mitigation , the development and implementation of data quality ... and the data governance program in general. This role will help support the overall data governance effort by providing data stewardship guidance across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improvement initiatives along with various therapy area communications/global/NNI decisions/ support Risk Identification and Mitigation : Identify potential ... Business Operations Management: Develop and implement efficient business processes to support therapeutic area therapy area objectives. Oversee day to day operations… more
- Merck & Co. (North Wales, PA)
- …and translational research strategy to test the hypothesis.--Alignment, risk mitigation & strategy implementation:- align with asset development team strategy.- ... scientific insight to identify gaps and risks, pro-actively develop mitigation plans.- Work with matrixed stakeholders to ensure implementation.--Collaborate with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …out and reporting.Proactively assess potential risks to the study and propose mitigation plans.Monitor study budget against trial progress and bring deviations to ... costs.Ensure study budget is reconciled with Finance on an ongoing basis. Support all inspection readiness and quality initiatives pertaining to assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …out and reporting.Proactively assess potential risks to the study and propose mitigation plans.Monitor study budget against trial progress and bring deviations to ... costs.Ensure study budget is reconciled with Finance on an ongoing basis. Support all inspection readiness and quality initiatives pertaining to assigned… more
- Eisai, Inc (Nutley, NJ)
- …of excellence, collaboration, and continuous improvement. Provide coaching, guidance, and support to team members, ensuring their professional development goals can ... processes to protect the organization's infrastructure assets.7. Risk assessment and mitigation : Collaborate with the Global Security & Compliance team to conduct… more
- Novo Nordisk Inc. (Irvine, CA)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... and internal/external partners. Essential Functions Delivers all relevant services/tasks in support of the planning and implementation of quality driven clinical… more
- Merck & Co. (Rahway, NJ)
- …activities. The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively ... perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals...as well as other established and emerging authorities.Lead and support GCP inspections, worldwide.- The CQOM may be assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy with a focus… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... and internal/external partners. Essential Functions Delivers all relevant services/tasks in support of the planning and execution of quality driven clinical trials… more
- Merck & Co. (Rahway, NJ)
- …is an essential component of the current IT division that provides support to the Pharmaceutical Research (Research and Development Division), Supply Chain ... the associated enterprise assets, and cost-effective delivery of capabilities to support achievement of immediate and future state business objectives.The SAP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …launch across therapy areas / brands and that resourcing is in place to support launch strategy initiatives. Owns launch process roadmap to support launch ... success. Establish processes and governance structure to support new launches, strategic program management, and market readiness Tools and Templates: Develop and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality oversight and strategic quality advice to the ... an effective working relationship with US FDA and other international bodies. Support the global quality annual objectives, strategic initiatives to deliver against… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to maximize customer centricity across the TA market Early Commercialization Strategy: Support the development of the therapy area/brand value story and positioning ... baseline assumptions and market scenarios. Define forecast risks and mitigation strategies. Lead decisions around resourcing allocation and account planning… more
- Insmed Incorporated (Bridgewater, NJ)
- …global company policies & proceduresLead overall management of Quality Assurance programs to support the QC lab and to ensure they are meeting expectations, which ... QC Lab and operationsPartners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active… more
- Merck & Co. (North Wales, PA)
- …mentoring and coaching to Sr. Scientist and Assoc Principle scientist in support of their assigned projects. Position Description- The Principal Scientist / Director ... assessment of the probability of regulatory success together with risk mitigation measures.Lead the development, communication, and review of the CMC Regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development project. As a project manager this ... departmental level objectives and may also participate on a non-project initiative in support of these objectives. This position will report to the Sr. Director,… more
- Aequor (NJ)
- …the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4. The ... teams. Proactively defining, planning, and communicating clinical supply strategy in support of global clinical studies, as well as monitoring and reacting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational processes and identifying the latest digital tools and technologies to support MCT activities. The Director serves as primary functional partner and MCT ... Act as a subject matter expert in MCT function and technology, providing support to internal and external customers and contributing to training and knowledge… more
- Tris Pharma (Monmouth Junction, NJ)
- …in each other and in respectful, open and honest communications to help support individual and team success.We have an immediate opening in our Monmouth Junction, ... detection, risk communication including safety information updates, potential risks mitigation , etc. Collaborates with appropriate clinical, medical, quality and… more
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