- 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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Evolution o Establish product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies to ... measurements that are consistent with the priorities of the business o Recruit, build and lead a highly effective marketing team o Manage US and central funding… more
- Aequor (New Brunswick, NJ)
- …CTDO activities.Work with Supply Chain and Inventory Process Excellence team to support inventory forecasting process.Proactively support internal control compliance ... internal audits and SOX compliance testing of CTDO plants/processes, lead remediation of identified control deficiencies.Support CTDO Finance on ad-hoc… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies that enhance the overall customer experience across all touchpoints. This role will lead a skilled team of behaviour science experts to design and ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... process for Novo Nordisk's top PBM/payer accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to Contract (includes pre-deal… more
