- 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
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for the development and sustainability ... of the Global Clinical Data Standards for quality submissions and success of the Daiichi Sankyo R&D...also some of the requirements of this role. The Manager , Clinical Data Standards should be a subject matter… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality , and expedite the preparation of oncology compound regulatory submission. It ... programming standard on datasets and TFLs to improve efficiency and quality .Responsibilities- By leading internal programming contractor or by self, perform… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.Procedure Development: Supports the process ... redesign activities to ensure compliance and consistency across clinical study start-up activities. Reviews and provides input to SOPs, SOIs, and process guides.Qualifications: Successful candidates will be able to meet the qualifications below with or without… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. 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...collection of diverse external data types. Advises Study Data Manager on complex vendor management issues and provides guidance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Manager , ERP Applications is accountable for maintaining and modifying assigned ERP ... elements of each enhancement or project.Responsibilities:Responsible for developing high quality solutions based on Functional Design documents. Perform system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research 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
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review ... policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC Lessons… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor performance, assessing spend, maximize value from vendors, ensure service quality . Reduce costs without compromising quality . Monitor projects and ... seek efficiency. Mitigate potential risks, including any third-party disruptions.- Evaluate current vendor processes and systems for continue to enhance programs. - Legal and Compliance Management- Manage and oversee complex processes for approval of material… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Ensures all systems and data operate and are maintained to the agreed quality and service requirements- Leads the planning and deployment of system upgrades, ... including the scheduling of key activities and communicating of system downtime to appropriate parties. Identify opportunities for automation and reduction of manual processes across the team in conjunction with our Financial Disbursements roadmap.- Leads… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... of drug products for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Operations Manager is an exempt level position working within Technical...multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... internal programming colleagues in completing the deliverables with high quality according to timelines, and provide recommendations to improve process.Compliant… more
- Daiichi Sankyo, Inc. (New York, NY)
- …centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory ... Manager represents the assigned product(s), and their approved indications,...as per SOP 805.21,'Reporting Adverse Events (AEs) and Product Quality Complaints (PQCs).' Qualifications: Successful candidates will be able… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... Position We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work...Minimum 2 years of experience as a Clinical Trial/Project Manager Experience with global clinical trial operations, in multiple… 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 ... attainment of project milestones Develops solutions for process improvements; enhance quality and budget accuracy via financial modeling and automation Responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.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 profile.CRO / Vendor Oversight: Review CRO/vendor… 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 ... difference? The Position The HEOR Strategy and Evidence Synthesis Manager will be part of the HEOR Evidence Synthesis...by the RWE and modeling teams within CDSE. The Manager , HEOR Evidence Strategy and Synthesis is responsible to… more
