- 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
- 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
- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking a Employee Engagement Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewJoin our dynamic team at Legend ... We are looking for a dedicated and action-oriented Employee Engagement Manager to lead our engagement initiatives. In this newly created role, you will be… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team , and be responsible for ... Depending on the status of development of the compound, lead and medical-scientifically direct a team of...as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other relevant sources… 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Buyer/Planner as part of the Supply Chain team based in Raritan, NJ. Role OverviewThis individual will work within Technical Operations ... skills, and Power BI skills with the ability to quickly analyze data and re-balance inventories supporting manufacturing activities to provide an optimal service… 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)
- …(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
- 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
- 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
