- 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 immune disorders. Summary The Global Oncology Medical Affairs (GOMA) Director , Program Management & Operational Excellence provides strategic planning… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards ... in fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and functional team members.Maintains global integrated project plans, project timelines, risk management plans and communication plans. Resolves complex ... immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework.… 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 ... application and other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of...Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to identify QA risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and to ensure continuous improvement ... in the management of CMO risks. Interacts with DS affiliates and...approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1-3… more
- Merck & Co. (Rahway, NJ)
- …country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure ... journey to become the premier "Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of the… 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
- 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 ... established, take main responsibility for CMC lead. Provide operational coordination and management to drive strategies and activities for early and late phase drug… more
- Merck & Co. (Rahway, NJ)
- …program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within ... Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, &...- At least 8 years of experience in project management . - - At least 5 years of… more
- Merck & Co. (Rahway, NJ)
- ….- We deliver critical building and site services , including facility management , emergency response, utilities (including electricity and water), and real estate ... across our Company enterprise.- - - Position Description - The Associate Director is responsible for identifying and driving improv ements to the reliability… 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
- Merck & Co. (Rahway, NJ)
- …is focused on delivering exceptional performance in value creation, supplier management , and risk mitigation through strategic sourcing initiatives for ... and employing rigorous sourcing methodologies to ensure effective cost management .The CSS group encompasses the following areas:HR Services: HR Operations,… more
- Merck & Co. (Rahway, NJ)
- …prior to headquarters submission.Manages regional programs (patient support, educational or risk management ) to support appropriate and safe utilization of ... Job DescriptionThe US Regional Director /Principal Scientist Medical Affairs (RDMA) is responsible for driving execution of the Value and Implementation (V&I) plans… more
- 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)
- …its customers, and shareholders. The scope of this group includes strategic program management , enterprise strategic planning, risk management , as well as ... ensure effective implementation and cross-functional engagement. Position Description: The Director of Commercial Strategy will support strategy development for… 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
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, ... cross-functional understanding and to support project timelines.Development experience in risk -oriented, regulated environmentsDevelopment project leadership with a proven track… more
