- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity ( Global R&D & PV QA) ... with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance,...QA across GxP (GCP/GVL/GCLP/GLP) systems.Lead the development of the global Data Integrity strategy and promote a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as...Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... operation of modules in SuccessFactors on a cross-regional / global scale. Specifically, this includes the set-up and performance...other tools as necessary and ensuring the connection and data flow with adjacent modules or other external process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery ... of laboratory data deliverables to support drug development processes and global submissions. This position provides leadership within Data Management by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...event in relation to the drug. Ensure all relevant data and findings are incorporated into comprehensive safety reports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Clinical Data Management globally and ensures execution of the global data management strategy across regions and across studies/programs. Lead DM ... activities. Operational Efficiency / Continuous Improvement:Leads standardization efforts in Data Management and ensure global implementation.Promotes automation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... of companion diagnostics (CDx) strategy in support of projects and Global Project Teams within Daiichi Sankyo's Early and Late-Stage Development Portfolio.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated...Case Report Form (CRF) annotation and SDTM dataset, identify data inconsistencies and support data review, review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... systems across the organization. This position ensures that all global systems, electronic records, validation processes, and regulated applications meet… more
- Merck & Co. (Rahway, NJ)
- …leveraging digital, data and analytics and measuring the impact. The Director of Global Commercial Pipeline Analytics will be responsible for developing ... Vaccines Global Commercial Pipeline Analytics, HHDDAOur Human Health Digital Data and Analytics (HHDDA) team is innovating how we understand ourpatients and… more
- Merck & Co. (Rahway, NJ)
- …Skills and Requirements: Work well in a matrixed organization and across global teams to drive alignmentMake data -informed decisionsBring a unique perspective ... to get the job done? If so, the Associate Director , Business of IT Strategic Communication and Change Management...new capabilities and tools that will advance how the global IT organization plans and delivers work. This role… more
- Merck & Co. (Rahway, NJ)
- …with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics ... to regulatory filings (IND, MAA, BLA) Prepare for and support inspections with global health authorities (FDA, EMA, JNDA, TGA) Unite diverse internal and external… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics - - Immune/Oncology - (QP2-IO) - team in the role of Director . QP2-IO team is part of the Global Clinical Development organization and ... Job DescriptionJob Description Director -QP2-IO We are seeking an experienced talented...size and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in… more
- Merck & Co. (Rahway, NJ)
- …work.-Develops American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value DossiersDevelops supplementary clinical data package in close ... the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic… more
- Merck & Co. (Rahway, NJ)
- …at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director ... continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision and/or lead… more
