- Eisai, Inc (Nutley, NJ)
- …Provide scientific support for clinical development planning, study design/execution, and data monitoring to ensure successful implementation of high- quality ... as a medical monitor and provide input into clinical issues , adverse events, laboratory data and patient...and engaging in periodic literature review.Lead processes for team management in terms of goal setting, performance, development, 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 ... different phases.The VP of Global Clinical Operations is responsible for the management , oversight, and direction of the clinical operations function in the… more
- Eisai, Inc (Nutley, NJ)
- …business decisions. Can apply financial analysis to build business cases that drive quality decision making and management processes.Travel is estimated at 30% ... recent launch experience, digital marketing, life cycle planning, finance/forecasting/budget management , sales force training, IC plan development, KPI tracking,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the drug development process.Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials ... to ensure data quality /integrity and regulatory complianceEnsures that Data Management Plans are consistent and regulatory compliant across studies and… more
- Merck & Co. (Rahway, NJ)
- …Sites, Global Regulatory Affairs (Labelling), Quality and the Material Master Data Management Team).Coordination of dossier & variation timelines with Global ... compromised of Global Supply Chain, Global Regulatory Affairs, Labeling, Material Master Data , Finance, Quality , Transfer Team, Transfer Donor Sites and Transfer… more
- Merck & Co. (Rahway, NJ)
- …the team alignment with functional objectives.Ability to communicate program progress, issues , and mitigation plans to the senior management .Innovative mind-set ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
- Merck & Co. (Rahway, NJ)
- …and biostatisticians and/or epidemiologists within BARDS, as well as stakeholders in data management , medical writing, and clinical operations to gather and ... ( data , analyses, tables, graphics, listings) also required.Must possess ability to identify data issues and understand complex data structure; to quickly… more
- Merck & Co. (Rahway, NJ)
- …Logistics, Clinical Trials Monitoring, Consultative Approach, Cross-Cultural Awareness, Data Analysis, Drug Development, Ethical Standards, Innovation, Management ... Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications… more
- Merck & Co. (Rahway, NJ)
- …Partner).-- Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Merck & Co. (Rahway, NJ)
- …Development, Process Analytical Technology (PAT), Program Implementation, Protein Chromatography, Quality Initiatives, Risk Management {+ 4 more}-Preferred ... gains in support of our company's World Class Supplier and Operationalizing Quality goals.- The Senior Scientist position is a laboratory-based scientific track role… more
- Merck & Co. (Rahway, NJ)
- …of submissions in the area of combination products. - Resolve complex project issues through collaboration with the team and cross functional partners and provide ... submissions/variations, 510(K)s, CE markings.- - Collaborate with Device Development, Device Quality , and other Drug stakeholders to communicate and align on new… 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 ... in compliance with CDISC and submission requirement, review submission data package and ensure its quality and...quality , proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …groups, CROs, Affiliates in order to ensure high data quality and proactive detection and resolution of issues .External Engagement:Continuously review ... between R&D and Medical affairs, particularly in case when issues impact Medical Affairs programs. Ensure requirements are in...process improvements to stakeholders via the QMS framework (ie, Quality Management Review, Quality Review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … quality teams to support GRA meeting company policies for quality management (eg, completing requests/initiatives from the GSOP Committee)Proactively manage ... Engineering, Statistics, or related field required Experience:4 or More Years Experience in quality management in the pharmaceutical industry and quality … more
- Merck & Co. (Rahway, NJ)
- …collaborate closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success ... knowledge of process equipment and operations.- Troubleshoots equipment/systems to resolve issues and aid in technology and process development, capturing learnings… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the ... Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional Global… more
- MUFG (New York, NY)
- …Sr Management communication and reporting + Build Management reports reflecting the quality of RWA data and disseminate to Liquidity / ALCO and senior ... provide more details. **Responsibilities:** + As part of the Data Management & RWA Capital team work...data governance including (and not limited to) identifying data elements, reporting data issues … more
- Citigroup (New York, NY)
- …to contribute to achieving business goals + Report Data Quality issues through Citi's corresponding Data /Issue management process + Strong analytical ... Data Governance Council specific to ERM Domain issues including Critical Dat Elements management , ...support programs for the development and implementation of best-in-class Data Quality management policies, procedures… more
- Citigroup (New York, NY)
- …streams focusing on broad range of data initiatives including data requirements, issues management , Data Quality rules, lineage, Data ... equivalent, in Management of Technology, Information Technology, Data Management , or a related field, and...with a Master's, must include: Performing detailed analysis of data issues and related processes and controls… more
- TD Bank (New York, NY)
- …Trade Surveillance teams, CDO, Compliance Technology, and Front Office Technology on surveillance data quality issues . Engage with regulators and Internal ... program. + Issue Resolution & Root-Cause Analysis: Investigate and remediate surveillance data - quality issues , implement controls to prevent recurrence, and… more
