- Merck & Co. (Rahway, NJ)
- … (SDS QM), provides oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and ... to convert complex ideas and information into simple readable formSolid project management skillsFamiliarity with clinical data management conceptsStrategic… more
- Merck & Co. (Rahway, NJ)
- …for large molecule products.Coordinate project planning, resourcing, progress reporting , troubleshooting and people management .Provide technical oversight ... related field with fourteen (14) years of combination of experience including team management , technical expertise in cell culture, and regulatory knowledge in… more
- Merck & Co. (Rahway, NJ)
- …projects under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other ... Travel Requirements: 10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills: Data Management , Data Science, Numerical… more
- Merck & Co. (Rahway, NJ)
- …Improvements, Project Management , Project Risk Assessments, Regulatory Affairs Management , Regulatory Reporting , Regulatory Training, SAP Global ... in audits and assurance impacting these areas.- They will work with global trade management programs to ensure all classification master data is maintained and… more
- Merck & Co. (Rahway, NJ)
- …of technical expertise in cell culture sciences, leadership and project management , and regulatory knowledge in the Pharmaceutical/Biotech industry; ORMaster's ... of technical expertise in cell culture sciences, leadership and project management , and regulatory knowledge in the Pharmaceutical/Biotech industry; ORPh.D.… more
- Merck & Co. (Rahway, NJ)
- …Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management , Regulatory Reporting , Regulatory Training, SAP ... trade management systems to ensure that trade related master data and processes are maintained.Qualifications and skills Bachelor's degree required3+ years… more
- Merck & Co. (Rahway, NJ)
- …in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, graphics, listings)Strong project management skills; leadership ... an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM standardsDemonstrated… more
- Merck & Co. (Rahway, NJ)
- …and biologics commercialization within the expansive Biologics S&T portfolio. Reporting directly to the Biologics Drug Substance Commercialization Leader, you ... sites. You'll build the foundation for long-term robust manufacturing, enhance data monitoring capabilities, and drive excellence in safety, compliance, supply, and… more
- Merck & Co. (Rahway, NJ)
- …medicine leader in our newly created Precision Medicine and Diagnostics function. Reporting to the Associate Vice President ,Precision Medicine and Diagnostics, in ... be the authority in defining and interpreting the translational experiments and data generated respectively from our clinical trials, and understanding the potential… more
- Merck & Co. (Rahway, NJ)
- … of customs origin;Manage the origin related content on teamsites;Work with global trade management systems to ensure all origin master data and processes are ... SAP GTS or Integration Point, or similar databases, very desirableStrong project management skills and ability to conduct complex reporting processesSustained… more
- Merck & Co. (Rahway, NJ)
- …ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also assist ... Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management ). Lead Periodic Business and Operations Review Meetings (with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriate KPIs/metrics to track process compliance, performance and adherenceWork with the data /systems SMEs to define reporting needs to oversee process ... key markets (Required)2 or more years with experience coordinating and managing regulatory audits and inspections, incl. CAPA management (Prefered). Travel:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …knowledge of medical terminology capture and reporting of safety data , pharmacovigilance, industry best practices, and relevant regulatory requirements. This ... around rare diseases and immune disorders. Summary: The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery of laboratory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… more
- Eisai, Inc (Nutley, NJ)
- …of innovative strategies.Experience in managing and directing related functions such as data management , CRO vendor management , procurement, and ... ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …findings are incorporated into comprehensive safety reports as required by all regulatory authorities.Ensure a robust risk management process with appropriate ... safety physicians and scientists in individual case medical review, aggregate reporting , risk management , and/or translational researchMust have excellent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety ... of medical accountability and oversight for one or more clinical trialsMatrix management responsibilities across the internal and external networkManages Phase 1 -… more
- Mizuho Corporate Bank (New York, NY)
- …Lead (Operational Risk Management ) We are seeking an experienced Data Management & Regulatory Reporting Subject Matter Expert (SME) at the ... role is a key partner in strengthening both our data management capabilities and regulatory risk reporting oversight. In this integrated role, you will… more
- Synchrony (New York, NY)
- …to submission, facilitate reviews and approval with Senior Management + Lead regulatory reporting data strategy for the Company, continuously driving ... data and increasing automation efforts + Lead Regulatory Reporting Systems team in supporting various...and analytical tools including Hyperion / Oracle Enterprise Performance Management + MBA / Master in Accountancy preferred +… more
- American Express (New York, NY)
- …**Minimum Qualifications** + 7 years of experience in data governance, risk management , operational controls, or regulatory reporting in a large ... seeking a strategic and disciplined leader to oversee the Data Issue Management & Risk Monitoring function...data issues and risks that impact financial integrity, reporting , and regulatory compliance. The ideal candidate… more
