- 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians, and is tasked with ... high-performing organization that:Attracts and cultivates essential skills needed for data science and AI, ensuring the team ...and vision.Build and evolve the Data Science team to meet internal and market needs. Lead … more
- Merck & Co. (Rahway, NJ)
- …company to save and improve lives. Within IT, the IT Strategy Realization (ITSR) team 's purpose is to lead value-driven outcomes and accelerate how we transform ... (FTE) and contingent workers, ensuring effective collaboration and performance across team members. Principal Responsibilities Change Management Lead Assess the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical & privacy ... standards and ensuring adherence to corporate and legal regulations, this team is constantly called upon to design and implement creative solutions to complex… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functionally to ensure successful implementation of the CDx and associated data collection. Oversees clinical trial sample testing activities and data ... Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of… more
- Tris Pharma (Monmouth Junction, NJ)
- …science and technology.Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris' passion ... But of equal importance to each member of the team is how we interact with one another on...reconciliations, etc., to support department operations and analysis.ESSENTIAL FUNCTIONS Lead the Brand gross-to-net financial close process including but… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... and refine our strategies based on real-world results. We are building an intentional team culture that is made up of diverse skillsets, united by the shared belief… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the ... (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …mix. Provides mentoring to junior members of Market Access Insights & Analytics team in adopting advanced data engineering methods. Continues to assess product ... strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our… more
- Merck & Co. (Rahway, NJ)
- …new ATs, considering when multiple registrational-intent tumor strategies-are anticipatedThe Asset Team VP will manage individuals who lead multi-tumor asset ... Job DescriptionThe Vice President, Oncology Asset Team is responsible and accountable for the end-to-end lifecycle management for our company's late-stage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- The DepartmentAt Novo Nordisk, our Marketing & Patient Solutions team is focused on redefining health for the millions of people that can benefit from Novo Nordisk ... for patients and healthcare providers. We are a group of innovative, data driven, cross-functional leaders that focusing on driving the strategy and execution… 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)
- …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
- Merck & Co. (Rahway, NJ)
- …analytics capacity. The ideal candidate will lead a cross functional insights team that spans data science, market research, data strategy, forecasting, ... & Analytics will be responsible for developing and communicating data -driven and actionable insights that drive greater customer and...goalsThis hybrid role requires the individual to be a lead partner to US vaccines marketing teams in a… more
