- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the...acts as a "change agent" within DS to ensure compliance and alignment with DS highest standards. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Principal Scientist of Device Technology Assessment and Early Development will spearhead early-stage device technology evaluation ... and assessment of emerging drug delivery device technologies. The ideal candidate will lead efforts in assessing the viability of new concepts and drive early… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and ... based in Raritan, NJ. Role OverviewThe QA Document Control Lead role is an exempt level position with responsibilities...in a sterile GMP environment. This role will ensure compliance within the document management system, document storage and… more
- Merck & Co. (Rahway, NJ)
- …device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position ... applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Merck & Co. (Rahway, NJ)
- …a Growth and Improvement-minded Chief of Staff for Small Molecule Science & Technology who can help drive our Strategic Operating Priorities.Invent: Pursue the most ... competitive advantage for us.Summary, Focus, and Purpose:Small Molecule Science & Technology (S&T) is responsible for providing scientific and technical support for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 120 years of scientific expertise and a presence in ... primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including critical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... Oversight Management:Support monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to meet business objectives.Support Investigations team by providing quality and compliance input for continuous improvement; and remediation's. Lead continuous ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- Merck & Co. (Rahway, NJ)
- …of our communications efforts.Scope of work and core responsibilities include: Lead the development of communication strategies grounded in data insights, ... strategies.Guide vision and structure of enterprise social intelligence operations, serving as lead contact for all social intelligence needs.-Stay up to date on the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV) service… more
- Genmab (Plainsboro, NJ)
- …and ensure effective team planning.Regulatory and Audit ComplianceEnsure compliance with country-specific clinical supply regulations.Represent GCDS during GMP ... to support efficient operations.Forecast demand, manage inventory, and prevent stockouts. Lead cross-functional collaborations, including Clinical Project Supply Team discussions.Change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring compliance with technical ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Genmab (Plainsboro, NJ)
- …ensure standards are met for test automation, quality, performance, security, and compliance .Stay current on leading practices and modern technology trends in ... adhering to well-architected-frameworks and delivery standards for excellence in execution. You'll lead a skilled team, with the potential to expand, focusing on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics ... well as advancing a culture of scientific excellence and compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics… more
