- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect ... information, analyze quality related process, define strategies to lead to the...Develop tools, deliverable formats and methodologies for process improvement, management of compliance requirements and effectiveness check review to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions to meet smooth ... transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead… more
- Merck & Co. (Rahway, NJ)
- Job Description Product Manager , Trial and Site Management Product Line - - Job Description - - Our Company Research Labs IT team partners with the Clinical Trial ... and passionate P roduct Manager for Trial and Site Management P roduct L ine to own the product...closely with software engineers , UX designers, data engineers, quality engineers and other product teams and product leadership… more
- Merck & Co. (Rahway, NJ)
- …vaccines.- We deliver critical building and site services, including facility management , emergency response, utilities (including electricity and water), and real ... data collection systems and other strategies that-optimize-statistical efficiency and quality .Develop and-maintain-Site Facility Energy Regression models.Work with Operations and… 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, EU MDR, ISO 11608 Needle-based injection system for medical use.Familiarity with Design Verification (DV) strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation… more
- Merck & Co. (Rahway, NJ)
- …transformation journey to become the premier "Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will ... of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving shaping and delivery of impactful solutions that enable… more
- Merck & Co. (Rahway, NJ)
- …combination products, demonstrating a deep understanding of regulatory frameworks, quality management systems, and industry best practices.Exceptional strategic ... across technical transfer initiatives, working collaboratively with the Senior Director , Directors, and Associate Directors, and cross-functional teams.Utilize… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... 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)
- …self-awareness and build trust through effective communication and relationship management .Execution Excellence: Deliver high- quality outputs within deadlines ... is focused on delivering exceptional performance in value creation, supplier management , and risk mitigation through strategic sourcing initiatives for Human… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... requirements by their strong scientific background, excellent communications skills, and project management skills to derive high- quality reference data to meet… more
- Merck & Co. (Rahway, NJ)
- …for traceability / lineage and make them available for business consumption; Monitor data quality report and work proactively with IT on data issues as part of daily ... master and operational data which impacts dashboard reporting.Responsible for Data Management , that entails: Maintain Standard pricing across all species at multiple… more
- Merck & Co. (Rahway, NJ)
- …responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.The Director , Nuclear Magnetic Resonance Lead, is ... 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)
- …of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and ... toCoordinate project planning, resourcing, progress reporting, troubleshooting and people management .Serve as the scientific/technical mentor for junior staff.- Provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Technical Lead will ... Responsibilities This individual with provide direct support to the Director of Manufacturing Excellence by providing technical expertise to Technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …work assignment and oversight of the group. This position reports to the Associate Director Data Management Operations. Business administration activities ... processing of requests and delivery of periodic review reconciliation reports Project Management : Manage all quality deliverables for the timely processing of… more
- Howmet Aerospace (Dover, NJ)
- Howmet Engine Systems (HES) seeks a highly qualified Associate Quality Director . They will be sharing the responsibility for all aspects of Quality for ... multiple manufacturing facilities with the Quality Director , including systems ( Management System) and results...system of checks and balances that facilitate operations. The Associate Quality Director will assist… more
- New York University (New York, NY)
- …School of Professional Studies seeks an Academic Director and Clinical Assistant/ Associate Professor of Leadership and Management in the Division of Applied ... of Applied Undergraduate Studies (DAUS), the Academic Director oversees the associate and bachelor degrees in Leadership and Management . The Academic … more
