- Merck & Co. (Rahway, NJ)
- …device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position ... applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Merck & Co. (Rahway, NJ)
- …commercialization of our medicines, vaccines, and Animal Health products.The SAM Optimization Lead will be part of the center led Software Asset Management Service ... models and provide inputs to find optimization opportunities.- The position will also lead a team of analysts focused on one of the following asset types:End… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for synergies between the products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... across regions and functional areas. The role of the Global Process Lead involves developing and maintaining efficient, effective, and compliant business standards,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Genmab (Plainsboro, NJ)
- … Information Security will report directly to the VP and Global Head of Information Security and IT Risk & Compliance, playing a strategic role in the ... several platforms.Primary ContactsReports to the VP, Global Head of Information Security and Risk & ComplianceSecurity Officers...Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, such as Leadership Team… more
- Merck & Co. (Rahway, NJ)
- …sustainability in procurement and logistics processes.Furthermore, this role will co- lead the Environmental Sustainability Strategic Pillar for the Manufacturing ... Director will manage key challenges, including supplier relationship management, risk mitigation through robust business continuity plans, and responding to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and drive implementation strategy. Ensure seamless flow of knowledge and information across functions, and with other sites when applicable.Provide support and ... and consumables for compatibility with the Manufacturing process.Draft Process Risk Assessments for implementation of process changes.RequirementsBS/BA required in… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at least ... 3/4 program.This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this position… more
- Genmab (Plainsboro, NJ)
- …Evaluate regulatory risk and recommend mitigation strategies to global regulatory lead to ensure optimal regulatory success. Represent US RA in the Global ... will work in close collaboration with the Global Regulatory Lead (s) on a compound in late-stage development to implement...of the Company Core Data Sheep and US Prescribing Information . Responsible for maintenance of the IND. Monitor and… more
- Merck & Co. (Rahway, NJ)
- …expertise.The Associate Director brings forward strong subject matter expertise to lead studies and evaluations, determine suitability, establish direction, conduct ... risk assessments, define safeguards, assess operability, interface with vendors,...guidance are preferred.- Candidate should have demonstrated ability to lead a cross functional team through design and execution,… more
- Merck & Co. (Rahway, NJ)
- …to support decision making across vendor selection, contract negotiation & review and risk assessments and will be the primary point of contact to ensure financial ... controls, to calculate efficiencies across the network and to lead budgeting, forecasting and reporting activities. In addition, the Associate Director will… more
- Merck & Co. (Rahway, NJ)
- …expertise.The Associate Director brings forward strong subject matter expertise to lead studies and evaluations, determine suitability, establish direction, conduct ... risk assessments, define safeguards, assess operability, interface with vendors,...guidance are preferred.- Candidate should have demonstrated ability to lead a cross functional team through design and execution,… more
- Merck & Co. (Rahway, NJ)
- …is seeking a highly motivated and technically focused individual to lead the Crystallization Lab. Through direct, lab-based contributions and scientific supervision ... a team of crystallization subject matter experts, the Crystallization Lab Lead collaborates with cross-functional teams to ensure small molecule Active… more
- Merck & Co. (Boise, ID)
- …AHTS R&D / Tech Lab with complicated application packaging requests and risk assessments.Engineer IT solutions for remote AHTS field users using various tools ... as required.Complete special projects for Biomark and IdentiGEN as required Globaly.Act as the lead IT representative to gain the voice of the customer for AHTS R&D… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, responses to Health Authority)Participant and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …plans across functional teamsDefines the interdependent deliverables and ensures that quality, risk , cost, time are managed within the overall approved plan to drive ... criteria for the project.Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and implications… more
- Genmab (Plainsboro, NJ)
- …60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key responsibilities include ... This responsibility will involve collaboration with a partner. Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.… more
- Merck & Co. (Rahway, NJ)
- …work.The Principal Scientist, Engineering position leverages scientific/technical experience to lead process development teams to develop safe and robust ... candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This… more
