- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance ... exempt level position with responsibilities for providing quality oversight over the compliance program for the site Quality Control laboratories in support of both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 Leads (RQLs), ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...submission-relevant activities are performed.Liaise with the Global Audits and Compliance function to ensure compliance with programs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(SAP).Study Execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical ... data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality, integrity and compliance with ... Activities: Responsible for development and review of procedural documents that set compliance in QA GMP commercial and IMP processes and systems. Responsible to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and ... documentation of identified access discrepancies per study to maintain overall compliance and inspection readiness of the application. This position will establish… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies and applicable changes that may require DS support. Ensure respective compliance with applicable DSI and or DS relevant procedures, standards and ... experience including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit.Demonstrated experience dealing with contract manufacturing organizationsMust… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Manager role supports Government Pricing, Contracting Compliance , State Price ... FCP/FSS, IFF, and URA) and rebates for Federal Drug Programs in compliance with Genmab's methodologies and standard operating procedures.Oversee the analysis and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring ... compliance with technical and regulatory standards. This role involves...communication with stakeholders and the project team. The Project Manager identifies and mitigates risks, maintains high-quality deliverables, and… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Program Manager , Cleaning Validation as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Program Manager , ... assessment and cleaning efficacy studiesStrong understanding of regulatory and compliance requirementsExcellent oral and written communication skills Highly collaborative… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to...(minimum 3 of those years in a supervisory or manager role) Special knowledge or skills needed and/or licenses… more
- Genmab (Plainsboro, NJ)
- …Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical ... Drug Supply Manager you will play a pivotal role in ensuring...of clinical drug supply management.Oversee inspection readiness and ensure compliance with relevant regulations.Manage operational trial and project objectives,… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.Brand Finance Manager , US MarketThe Brand Finance Manager will play a critical role in ... to drive growth and ensure financial goals are met. TheBrand Finance Manager is responsible for supporting all aspects of brand financialperformance, including… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Senior Product Manager , Key Customer Strategy will shape, implement, and execute Key Account brand ... Commitment to the corporate culture of innovation, customer / patient-centricity, and compliance . Ability to travel domesticallyWhere you will workThis position is a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to maximize your potential with us? The PositionThe Manager of Master Data will work within the Master Data Team and will have ... stakeholders including, but not limited to, the Information Technology, Analytics Governance, Compliance , Field Systems and Field Force teams, as well as other NNI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …possibilities for professional and personal development. Are you ready? The Position As Manager of Academy and Franchise within the NNI Employee Experience team, the ... from functions including STARS, Human Resources, and Legal, Ethics & Compliance around learning and development needs. External relationships may include interaction… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of audits and health authority inspections to ensure internal/external compliance with requirements/regulations Support the North America Clinical Development (NACD) ... organization across all phases of the Good Clinical Practice (GCP) audit process, as needed. This is inclusive of robust root cause analysis (RCA) and corrective and preventative actions (CAPA) authorship Maintains up-to-date knowledge of relevant industry… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Department At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ... on new procedures, to auditing against local and corporate policies, to reporting compliance -related issues, ECP keeps us accountable every step of the way as we… more
