- 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
- Merck & Co. (Rahway, NJ)
- …for proactive resourcing planning, risk assessment strategies, and budget management as necessary.The Director , Nuclear Magnetic Resonance Lead, is expected ... Analytical Enabling Capabilities Department has an exciting opportunity for a Director of Nuclear Magnetic Resonance (NMR).- The NMR Lead provides strategic… more
- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within… more
- Merck & Co. (Rahway, NJ)
- …is focused on delivering exceptional performance in value creation, supplier management , and risk mitigation through strategic sourcing initiatives for ... and Supplier Development & Performance Management (SD&PM) to ensure effective management and reporting of initiatives to senior leaders and stakeholders.Key… more
- Merck & Co. (Rahway, NJ)
- …communicate with stakeholders at various levels, including cross-functional teams, senior management and external vendors. Strong negotiation, influencing, ... .- We deliver critical building and site services , including facility management , emergency response, utilities (including electricity and water), and real estate… more
- Merck & Co. (Rahway, NJ)
- …to join the Global Safety Center of Excellence (CoE) team as an Associate Director , Safety Programs CoE.- This individual will be responsible for the management ... portfolio of corporate safety programs that may include High Risk Work, Fire & Life Safety and other similar...and prepare supporting data for required government, industry and management reports. Required Experience and Skills: To excel in… more
- Formation Bio (New York, NY)
- …product release, stability programs, change management , and vendor oversight. The Sr . Director ensures compliance with cGMP standards, oversees QA activities ... mission to bring new treatments to patients faster and more efficiently.About the PositionThe Sr . Director , GMP Quality Assurance will lead the GMP QA strategy… more
- Merck & Co. (Rahway, NJ)
- …its customers, and shareholders. The scope of this group includes strategic program management , enterprise strategic planning, risk management , as well as ... communicator with excellent verbal and written skills; ability to speak effectively with senior management and across all levels of the business Growth mindset.… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionAs Senior Director , Business Transactions, reporting to the Chief Business ... and contracts, working alongside internal stakeholders and legal counsel. Financial & Risk Assessment: Conduct risk assessments and support financial due… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conduct is completed in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, ... and site staff, Health Systems, Contract Research Organizations and Site Management Organizations etc.) Establish and manage senior level relationships… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic integrated GOMA Franchise project plans, project timelines, high quality risk management plans, and communication plans, as needed.Operational ... and GMAT/Functional Leads for formal presentations/communications to GOMA Head and Senior management .Support Head, Program Management & Operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a non-project initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head ... and functional team members.Maintains global integrated project plans, project timelines, risk management plans and communication plans. Resolves complex… 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 ... of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project or...and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …performance and quality metrics and share with study team, Operations Program Lead, and Sr . Director for the compound, on regular basis and ensure actions are ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful ... Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and...activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee and mentor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Staff members of the Medical Promotional Review team report to the Director . Works with stakeholders throughout NNI and at external agencies. Key internal ... other key internal cross-functional teams where (s)he provides strategic input. The Director represents Medical on PRB working group and Steering Committee brand… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA and brand activities. Secure global funding and assess progress during pre-launch Risk Management : Proactively raises risks within the brand/launch plan to ... with US operations within life sciences preferred Excellent communication and stakeholder management skills, with ability to influence senior leaders Outstanding… more
- Genmab (Plainsboro, NJ)
- …Prescribing Information depending on the role for the assigned product Consult with senior management to develop and communicate regulatory strategies and advice ... Profile). For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health… more
