- Merck & Co. (Rahway, NJ)
- …fast-paced job that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position ... will report to the Director , Engineering and will be a member of the...role may support facility operations, process development activities, support compliance investigations/change management , author GMP documentation and… more
- Merck & Co. (Rahway, NJ)
- …lead equipment development and maintenance activities -and support facility operations, compliance investigations/change management in any of our enabling ... and/or qualification.Experience providing technical mentorship.Experience in leading and supporting compliance investigations and change management .Familiarity with US… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Office of General Counsel (OGC) is seeking a Director of IP Portfolio Integration to help drive our strategic operating priorities in alignment ... to assist in outside counsel and product candidate and marketed product matter management . This newly created position may be required to manage other team members… more
- Merck & Co. (Rahway, NJ)
- …Division functional areas (eg Legal, Finance, External Manufacturing, Supply Chain Management , EHS, Procurement, Quality , Science & Technology, and Manufacturing ... and understand resource requirements, supply, production plans, inventory, demand management , product costs, intellectual property, quality , capital needs,… more
- Merck & Co. (Rahway, NJ)
- …to further extend capabilities and functionalities on our existing Clinical Trial Supply Management (CTSM) solution in order to satisfy and deliver on the strategic ... experience coupled with extensive business & technical knowledge in SAP Supply Chain Management and Distribution areas with a strong focus in Clinical Trial Supply … more
- Merck & Co. (Rahway, NJ)
- … management duties.Through their leadership and strategic guidance, the Director will ensure that their interdependent and multidisciplinary team develops and ... team activities are completed with the highest regard for safety, quality and regulatory compliance .Qualifications:Education Minimum Requirement: This position… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... talent development, and partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell Based Sciences and will… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …manufacturing environment. Experience supporting compliance investigations and change management . Experience working with Quality systems. Experience working ... to lead and support facility operations, process development activities, compliance investigations/change management , authoring of GMP documentation, and… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position will report to the ... Director , Engineering, Automation Lead position and will be a...to ensure delivery of business objectives, including operational efficiencies, compliance , energy savings initiatives, improved reliability, operability and maintainability.-REES… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Privacy & Compliance Investigations, is a member of the ... IT, Medical Affairs, Sales/Marketing, Managed Markets, Pharmacovigilance, Supply Chain, Compliance , Quality Assurance, pharma-specific litigation issues, promotional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a culture of compliance at all levels.Create and maintain project management methodologies. Support the global GMP quality annual objectives, strategic ... collaboration with Global External Supplier QA teams.Collaborate with Global Quality Management System (QMS) teams on regulatory-related...to recommend metrics and report the state of GMP Quality and compliance of Daiichi Sankyo and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Associate Director will also be responsible for the creation, management , and documentation of GCO's CRO SOP review and maintaining the master Daiichi ... areas (eg clinical research & development, clinical science, clinical quality assurance, project management ) preferredStrong leadership, collaboration,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and issue management with strategic development partners.Close partnership with clinical quality management and other compliance functions within and ... centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk...risks.Manage and oversee the CTOR team who support GCO Quality by Design, risk and issue management .… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder ... The position holder will require strong skills in continuous improvement, project management , change management and risk management .Responsibilities Project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in due diligence activities during the vendor selection process.Close partnership with clinical quality management , SVO and other compliance functions within ... management oversight plans and establishes a comprehensive interface for risk and issue management .Support GCO Quality by Design, risk management , issue … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational ... Research, Research, Informatics Services, Project Management and Operational Management . Develop a strong,...architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Medical Director responsible for Communication Strategy and Medical Program Management on tracking and management of budget.Support Head of Publications- ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
