- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... of best practices and lessons learned. This role will also work with R&D Quality Assurance (R&D QA) and the respective operational functions to identify areas for… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment 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 Manufacturing Excellence Manager role is an exempt level position with responsibilities...is an exempt level position with responsibilities for providing quality oversight for the manufacturing process, equipment, and associated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. SummarySupport the PVQA quality strategy and quality plan with specialty and the Oncology ... Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct… more
- Insmed Incorporated (Bridgewater, NJ)
- …- driving projects to completion independently with the utmost integrity.Produces high quality work with minimal oversight from Manager .Possesses a 'can-do' ... fun? Yes? Then maybe you will be our next Manager of US Compliance! This role will implement day-to-day...and support in developing guidance documents and training. The Manager , US Compliance reports to the Senior Director, US… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …direction and leadership for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all ... organization, and driving continuous improvement initiatives to enhance investigation quality , timeliness, and productivity.Key Responsibilities Co-Lead Deviation Investigations: Collaborate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... programmer.Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... with not only technology vendor partners, but with Manufacturing, Process Development, Quality , and Regulatory to ensure approval of the selected platform. The… more
- Insmed Incorporated (Bridgewater, NJ)
- …of raw materials, components and services consistent with specified levels of quality , delivery, price and total cost. This position will support the Associate ... chain systems.Implement and maintain data governance practices to enhance data quality and reliability.Support maintenance of Item master and work definitions in… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... define priorities.Anticipate upcoming tasks based on the submission timelines.Perform quality control checks and coordinate comment resolution with publishing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate ... in accordance with DS standards. Act as the project manager of the clinical study team to liaise and...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the identification and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …any specialty vendors.Identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of ... success to ensure maximum impact and efficiency in overall feasibility processes and output.Contributes to process related improvement in process space. This includes gathering cross functional feedback to support significant process improvement efforts… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements. Support manufacturing investigations, create/revise operational ... 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. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …time. Collaboration and facilitation: Work closely with Raritan functions, particularly the Quality Control (QC), Quality , and Deviation Investigations Teams, to ... key performance indicators (KPIs) and ensure timely reporting to the Site General Manager . Problem Solving: Address and resolve any issues that arise during D2D… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a critical part of the Center for Data Governance ... outcomes.- Support the creation and us of policies, processes, data standards, data quality and enabling IT and digital technologies needed to establish and maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and 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. (Basking Ridge, NJ)
- …execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... with internal programming colleagues in completing the deliverables with high quality according to timelines, and provide recommendations to improve process.-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead… more
