- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sample materials.Perform spot-checks in the QC Laboratories to ensure compliance with written regulations, policies, procedures, and global procedures.Strive to ... reduce non-conformances in supported areas by proactively driving compliance .Perform tasks in a manner consistent with the safety policies, quality systems and cGMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.Work closely with operations ... records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, provide input on… 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The position will focus on maintaining House in Order by ensuring compliance with Sarbanes Oxley and Novo Nordisk Corporate Accounting guidelines in accordance ... Accounting at Novo Nordisk Inc. As part of the NNI Finance team, the manager will business partner with budget controllers (FP&A) and other key stakeholders across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access), Brand Marketing, Training, Market Access & Public Affairs, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has high exposure to ... brand marketing, market access, Enterprise Insights, sales, medical/CMR, legal, compliance , and regulatory. Other internal relationships include Public Affairs,… 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
- 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
- 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
- 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
- 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
- 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
