- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics ... in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality factors, select critical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management Operations ... stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external ...to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the leadership team . Lead an enterprise cross-functional QA team to deliver state-of-the-art data -driven solutions.Design a fit-for-purpose organization ... technologies, and drives process improvements. Collaborating with the Global QMS eCompliance team , the director oversees QA plans, promotes data governance, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation Leads ... rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development,...21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Approves the resolutions provided in the Local Lab FAQ log for Local Lab team discussion topics, data trends, and escalations. (- Accountable for inspection ... 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)
- …IT strategy.ResponsibilitiesStrategic Leadership, Platform management and Governance:Implement and lead the global strategy for process automation, RPA, and ... solutions within a controlled governance modelIntelligent Process Automation & RPA Implementation: Lead the deployment and optimization of RPA solutions using UI Path… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAn opportunity has arisen for a Sr. Data Scientist in the Pharmaceutical Sciences and Clinical Supply (PSCS) Organization. - The role will be ... building end-to-end solutions to capture, contextualize, and generate insights from data , and establishing best practices to provide solutions to otherwise… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject matter ... review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as the Point of Contact ... (PoC) for gathering country/region specific CDx RA requirements from local RA team members (eg from Japan, China, Australia, Canada, Korea etc.)For recruitment in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …designated programs.Ensure proactive representation of Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality ... quality oversight of strategic initiatives in close collaboration with cross functional leadership team (ie, OBU, SBU) and study teams to uphold the ethical conduct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, … more
- Merck & Co. (Rahway, NJ)
- …in full alignment with global strategy.Regional Supplier Management - Build relationships, lead team to manage supplier performance against business requirements ... Regional Category Manager (RCM) will work with the global team to lead the development and implementation...Actionable Insights - Work closely with the Process Excellence team to deliver meaningful data and insights-… more
- Merck & Co. (Rahway, NJ)
- …target commercial product.-Leads the cross-functional DCT, critically assessing all team deliverables & fostering a learning and collaborative environment. ... CMC and effectively communicates across the governance bodies, stakeholders, and team to drive outcomes/decisions through influence, advocacy, & negotiation with an… more
- Merck & Co. (Rahway, NJ)
- …Team Management: Lead a high performing Pune GCPA Vaccines team , driving data -driven decision making and delivering actionable insights to support ... Job DescriptionDirector, Vaccines Global Commercial Pipeline Analytics, HHDDAOur Human Health Digital Data and Analytics (HHDDA) team is innovating how we… more
- Merck & Co. (Rahway, NJ)
- …leading squads and maintaining product lifecycle Manage scientific applications and lead squads to build user-friendly scientific data and technology ... DescriptionLocation: PA, NJ, Boston/CambridgeThe Research and Development Sciences (RaDS) value team in R&D IT brings together product management, engineering, and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in improved commercial manufacturing processes and outcomes.The Director will build and lead a high-performing small team of technical experts, fostering a ... a Global Director of Platform Innovation as part of the Technical Operations team based in Raritan, NJ. Role OverviewLegend Biotech is seeking a Global Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across various regions, offering guidance and ... support to each product safety team in critical areas such as individual case medical...event in relation to the drug. Ensure all relevant data and findings are incorporated into comprehensive safety reports… more
- Merck & Co. (Rahway, NJ)
- …principles and ways of working to guide them through transformation initiatives. Team Leadership and Development: Lead , mentor, and develop the leadership ... as combination product stewardship for inline products. The Executive Director will lead multiple functions in the department of approximately 50 employees, spanning… more
- Merck & Co. (Rahway, NJ)
- …policies.The position will include, but is not limited to the following responsibilities: Lead the cross functional Global access, Team .Actively collaborate with ... Job DescriptionOur market access team is passionate about bringing our medicines and...to meet their needs.The Director, Global Market Access Oncology, lead the pipeline TROP 2 asset in combination launches… more
