- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data ... and processing of raw data and external data , CDASH/SDTM, industry best practices, and relevant regulatory...and clinical trial quality and risk management reporting requirements. Oversees the execution of external data… 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
- 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
- Merck & Co. (Rahway, NJ)
- …Facilitation, Process Improvements, Quality Improvement Programs, Quality Management , Regulatory Compliance Audits, Regulatory Reporting , Standards ... Detail-Oriented, Employee Training Programs, ICH Q10, Innovation, IS Audit, Management Process, Mentoring Staff, Pharmaceutical Regulatory Compliance, Policy… more
- 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)
- …candidate will be responsible toCoordinate project planning, resourcing, progress reporting , troubleshooting and people management .Serve as the ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… 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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …vaccine safety and efficacy, as well as analysis, interpretation, and reporting of final clinical trial results.Responsibilities also include the presentation of ... design and implementation of clinical studies, familiarity with biostatistics, and/or regulatory review process is desirable Proven leadership skills with the… 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)
- …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
- 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
- American Express (New York, NY)
- …an independent risk management framework to provide oversight on important regulatory reporting processes. Team will be responsible to create an oversight ... of analytical professionals to support and analyze financial and regulatory reporting risk to AXP. The team...and documentation of reporting instructions to ensure reporting requirements are met and appropriate data … more
- Mizuho Corporate Bank (New York, NY)
- …requirements and 5+ years of business analysis and relevant experiences in the Regulatory Reporting , Finance, Risk Management or related business functions. ... creation, strong understanding of data modeling and data visualization concepts, knowledge of regulatory report...5 years of experience in financial reporting , regulatory reporting , risk management , or… more
