- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , ... standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team ... based in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality … more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, company policies and procedures and-with quality standards internally and externally.Under the oversight of the CRD(Clinical ... individual is responsible to-manage/oversee a team of CTCs(Clinical Trial Coordinator).As line manager the role is critical to continuously develop future talent by… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Manager , NextGen Customer Engagement will support Novo Nordisk's strong commitment to its customers ... responsible for agile execution and support of new capabilities, platforms, and systems within Novo Nordisk in partnership with internal stakeholders and external… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simultaneously Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties ... of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview The QA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse...the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and provides guidance… more
- Merck & Co. (Rahway, NJ)
- …modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in ... so everyone can bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our Company 's DSCS Digital… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The ... ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.Reviews… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data quality rules and ... areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored ... clinical trial activities, ensuring adherence to timelines, budgets, project, and quality plans, and relevant ICH/GCP Guidelines Review protocols to ensure designs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems ... Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global DX, and QA-CSV/eCompliance team members… more
- Aequor (NJ)
- 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial ... during phases 1-4. The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of skilled technical experts to design, develop and implement Adobe Experience Manager (AEM) solutions that support digital transformation efforts and meet the ... Work closely with cross-functional teams to integrate AEM with other enterprise systems and third-party applications Lead the design and architecture of required AEM… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... TLG shells and specifications of variable derivation.Monitoring - develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the team has the necessary tools, infrastructure, and support to deliver high- quality AI solutions. Provide mentorship and guidance to individuals and teams on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the development and implementation of new processes, procedures and/or systems to improve organizational efficiencies and cost controls.Communication and ... strategy by spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process and procedures.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support ... maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the identification and… more
