- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and proficient in creation of process maps preferredExperience working with Quality Management systems preferredExperience with requirements related to global ... Director , Development SOP Management Join a...Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensuring the quality of PM activities including: communication, planning and management of schedule, budget, scope, issue risk management , and quality ... and Corporate Functions. They are responsible for ensuring consistent and effective management of approved Global and Regional IT projects and optimized PM resource… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... study and post-marketing protocols and the Clinical Study Oversight Plan, day-to-day management of DS Safety Notification Letter (SNL) System and oversee TMF… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssoc. Director of Support Operations (m/f/d)The Biotech facility embeds the latest technologies into the early stage clinical pipeline, helping to ... Phase Clinical Supply and Technology Innovation implementation into the pipeline.The Assoc. Director of Support Operations (m/f/d) will be a member of the Biotech… more
- Merck & Co. (Rahway, NJ)
- …of state-of-the-art technologies for batch and continuous manufacturing -with a Quality First, Safety Aways Mindset. -The Director Manufacturing Operations ... Clinical Supply and Technology Innovation implementation into the pipeline.The Director Manufacturing Operations (m/f/d) leads an Operating Unit responsible for… 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)
- …and collaborate with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest quality standards and drive ... Job DescriptionThe Senior Director of Device Product Stewardship will lead a...the portfolio overall and each product has robust lifecycle management plans, appropriate and rigorous technical support processes to… more
- Merck & Co. (Rahway, NJ)
- …requirements by their strong scientific background, excellent communications skills, and project management skills to derive high- quality reference data to meet ... Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is...nomenclatureLeading nomenclature and reference data projects or other data management tasksFacilitating timely delivery of high- quality scientific… more
- Merck & Co. (Rahway, NJ)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including ... and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and ManagementManaging ... readiness, cutover planning and execution, and post-go-live supportAdvocate change management within CSPV department by assessing org impact, proactively… more
- Insmed Incorporated (New York, NY)
- …experience.Other Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management /trial experience and 2 years clinical or research experience ... competitive pipelines and lifecycle plans, medical and pharmacy benefits, quality programs, etc.)Committed to self-improvement.Travel RequirementsUp to 80% domestic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational ... projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global) for given commodities/business areas and leading the overall supplier relationship management program for DSI, for DS products and alliances. Cultivates a ... responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug development processes and ... in working in a fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership,… more
