- Novo Nordisk Inc. (Durham, NC)
- …within compliance with a Quality Mindset that focuses on risk management & mitigation Support effective Change Management Support Corporate, OFP, local ... make what matters. The Position The QC Automation Engineer role will provide support & management of hardware & software on quality control laboratory computer… more
- Novo Nordisk Inc. (Durham, NC)
- …within compliance with a Quality Mindset that focuses on risk management & mitigation Implement effective Change Management Support Corporate, OFP, local IT & ... People Focus, Equipment Focus & Standards "Gatekeeper". Relationships Manager, Technical Support - OFP Essential Functions Work primarily with production (shop… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …identify and mitigate risks, advise on business strategies, and operationalize mitigation tactics. The position is instrumental in developing partnerships and ... to respective customer groups. The role is pivotal in driving strategic risk mitigation efforts in alignment with the E&C's risk assessment, management and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stages of the business development and strategic initiative lifecycle Provides support on enterprise-wide initiatives that have E&C considerations and implications ... governance and associated special projects Identifies, analyzes, and supports the mitigation of potential ethics and compliance risks to the organization, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready? The Position The P&O Operations Budget & Program Support at Novo Nordisk is responsible for ensuring effective centralization and management ... AB/RE Planning annually for all teams within P&O Budget and Invoice Support Responsible to manage financial tracking, reconciliation and goods receipts with all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management operations of the E&C team, ensuring the identification, assessment, and mitigation of compliance risks while maintaining and strengthening the culture of ... Essential Functions Develop and implement a comprehensive risk assessment, management and mitigation strategy for the E&C function and oversee Policies & Training,… more
- Aequor (South San Francisco, CA)
- …team in the Early Clinical Development (ECD) department is to optimize the support of clinical systems to provide high-quality clinical trial data insights and to ... the integrated Quality Risk Management Plan (iQRMP) and associated risk mitigation and control strategies, provide processes and tools for oversight of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pricing, personal injury), government investigations, product complaints, and risk mitigation /reporting for Novo Nordisk Inc. Provides strategic support ... and personal injury), government investigations, product complaints, and risk mitigation /reporting, oversees associated budgets, and drives successful implementation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities. Providing adequate and proper management of resources to support all projects and maintain business continuity.Managing productive cross-functional ... Regulatory Affairs, Clinical Operations. Formulates strategic approaches for risk mitigation for global products/TAs and ensures these activities are properly… more
- Genmab (Plainsboro, NJ)
- …will be supporting team members through troubleshooting, problem-solving, and developing mitigation plans for complex issues related to packaging and labelling ... vendor performance, ensuring delivery aligns with timelines and SOW.Provide direct support to team members in troubleshooting and problem resolution, ensuring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in Raritan, NJ. Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual ... will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations… more
- Genmab (Plainsboro, NJ)
- …progress of PMRs and PMCs, etc. Evaluate regulatory risk and recommend mitigation strategies to global regulatory lead to ensure optimal regulatory success. ... development of and assess the appropriateness of submission documentation to support successful IND and (s)BLA submissions. Evaluate various regulatory mechanisms… more
- Merck & Co. (Millsboro, DE)
- …materials, intermediates, and finished products.The focus of a Specialist within the Site Support (SS) team in the Bio Technology Solutions (BTS) department is on ... Vaccine and Biopharmaceutical process improvement/troubleshooting in support of commercial antigen/antibody manufacturing and sterile biopharmaceutical product… more
- Aequor (South San Francisco, CA)
- …process involves closely collaborating with scientists across the organization to support the overall safety assessment for our Client therapeutics spanning drug ... investigation to address target safety assessment, lead optimization and issue mitigation by employing state-of-the-science in vitro and ex vivo approaches. As… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to maximize customer centricity across the Rare Bleeding TA Commercialization Strategy Support development of the therapy area/brand value story and positioning to ... including baseline assumptions, market scenarios as well as risks and mitigation strategies Lead decisions around resource allocation and account planning to… more
- Merck & Co. (Rahway, NJ)
- …clinical supply chain deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders. Works ... and Clinical Finished Goods). Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain… more
- Merck & Co. (Rahway, NJ)
- …across the lifecycle of product franchises, (2) project and portfolio management support across pipeline and supply, and (3) the development and advancement of ... emerging regulatory expectations, and enterprise leadership of technical priorities in support of the value chain.Horizon analyses of emerging technologies to… more
- Genmab (Plainsboro, NJ)
- …will involve collaboration with a partner. Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success. Represent GRA in global ... development of and assess the appropriateness of submission documentation to support successful IND/CTAs as well as BLAs/MAAs. Evaluate various regulatory mechanisms… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are ... through creation of briefing materials and meeting preparation Lead and/or support global filing activities for submissions Present regulatory strategies including… 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 ... etc.). This includes contributing to new regulatory processes and providing training support as appropriate Contributes to the development of SOPs, Work Instructions… more
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