- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions ... no Sr CMC Lead is established, take main responsibility for CMC lead . Provide operational coordination and management to drive strategies and activities for… more
- Merck & Co. (Rahway, NJ)
- …and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs ... culture in Global Regulatory Affairs and Clinical Safety for business process management and continuous improvement.-Establish and lead assigned domain Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... Research, Research, Informatics Services, Project Management and Operational Management . The Tech Lead must have the ability to develop a strong, positive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …operational performance, identifying trends, and implementing corrective actions when necessary Risk Management : Assessing and mitigating risks associated with ... focused approach, leveraging competencies, tools and technology, and with change management skills. Ensures business needs are met through alignment of business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication, planning and management of schedule, budget, scope, issue risk management , and quality/outcomes. Communication: Ensure that assigned PMs ... program benefits in alignment with the organization's strategic objectives. Lead PgMs and PMs to manage the delivery of...track and adheres to the strategic goals. Issue and Risk management and reporting: Ensure that assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This position can be assigned to ... and functional team members.Maintains global integrated project plans, project timelines, risk management plans and communication plans. Resolves complex… more
- Merck & Co. (Durham, NC)
- …while focusing on equipment uptime, minimizing cost and maintaining process consistency. Lead scenario planning, risk assessments, and prioritization of critical ... team in this new and exciting facility will have the unique opportunity to experience commercialization which includes facility start up, licensure, and ramp… 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
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary The ITSM Process Manager for Change Management is responsible and accountable for managing and maintaining the IT Change ... Management process. You should be familiar with normal, standard,...global environment.Responsibilities- Process Ownership and Coordination. Act as a Lead function and process owner on a global level… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance objectives Works collaboratively with NNI's cross-functional ethics and compliance risk management stakeholders to develop healthcare compliance ... by strategically identifying, assessing, and mitigating the organization's top risk areas. The role serves as the lead...risk mitigation efforts in alignment with the E&C's risk assessment, management and mitigation program. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at ... Phase 3/4 program.This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this… more
- Merck & Co. (Rahway, NJ)
- …Diversity and Environmental Sustainability, in alignment with the company's overarching ambitions. Risk Management : Develop and enforce risk mitigation ... The Executive Director will manage key challenges, including supplier relationship management , risk mitigation through robust business continuity plans, and… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …its application to drug development required to deliver time, cost, quality, and risk management to teams.Demonstrated results in creating and managing complex ... OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy… more
- Merck & Co. (Rahway, NJ)
- …development through the implementation of the business solution using the Capital Management stage gate process with varying degrees of responsibility and will ... exhibit sound leadership and exemplary partnership, communication, and vendor management skills.- They are expected to develop and maintain advanced technical… more
- Merck & Co. (Rahway, NJ)
- …Crystallization Lab Lead also plays a key role in talent management of junior engineers while driving departmental initiatives.-A high level of innovation, ... communication and collaboration skills.Good organizational, interpersonal, writing, and time management skills. Lead and operate within a cross-functional process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1-3 ... questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)May participate in Site Initiation Visit (SIV)… more
- Merck & Co. (Rahway, NJ)
- …internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working ... & connectivity between functions supporting pipeline (ie clinical development, Compound Management Coordination , supply chain, & human health), and balancing needs… more
