- Daiichi Sankyo, Inc. (Bernards, NJ)
- …master file is complete and accurate for assigned stud(ies).Ensure that a study level operational risk management plan is in-place and applies a smart- risk ... or outsourced studies with elements of insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions,… more
- Eisai, Inc (NJ)
- …key liaison across internal teams and external partners, the Director drives operational excellence, risk mitigation, and inspection readiness while fostering ... strategies that achieve cost efficiencies, improve vendor performance, and minimize risk .Manages vendor qualification processes and partner with Vendor Risk … more
- Insmed Incorporated (NJ)
- …cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk ... We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will… more
- Genmab (NJ)
- …early indication assessments, country and site selection, patient recruitment forecasting, and operational risk analysis.Serve as a senior strategic partner to ... clinical trials across Genmab's development portfolio. This role balances operational ownership of high-impact feasibility work with broader leadership… more
- Insmed Incorporated (NJ)
- …across all Insmed locations and functions. The position will be responsible for minimizing risk to employees, visitors within operational lab assets or in office ... comprehensive EH&S vision, policy framework, and long-term roadmap aligned with Insmed's operational goals and risk profile, including periodic program reviews… more
- Twist BioScience (South San Francisco, CA)
- …structures that create long-term value by balancing commercial opportunities with risk and operational feasibility.Contract Management: Create and negotiate ... based on factors like sample volume, forecast models, quality, and operational capacity. Manage the contract lifecycle, including amendments, renewals, and… more
- Merck & Co. (Rahway, NJ)
- …and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying process ... inefficiencies using operational excellence tools and ensuring alignment with global regulatory...strategies and drive continuous improvement in design control and risk management processes. This individual will be expected to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks ... Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier contracting. Relationships This job reports to the Managing Assistant General… more
- Syner-G BioPharma Group (Boston, MA)
- …biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees ... commissioning and qualification of facilities, utilities, and equipment (FUE).Assist with risk assessments, feasibility reviews, risk mitigations, and testing of… more
- Merck & Co. (North Wales, PA)
- …to integrate INT operations into treatment sites, and address potential operational bottlenecks at sites, ensuring a smooth commercial ordering experience. Provide ... business needs for intismeran autogene, including treatment site readiness and INT operational needs. Identify strengths and risks to customer experience in the… more
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