- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead ... implementing best practices to help facilitate the inspection readiness mindset.Facilitates clinical quality risk identification and the necessary problem… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a...management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …also act as PV Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.Global Clinical ... data capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.Procedure Development: Supports the… more
- Insmed Incorporated (San Diego, CA)
- …effective scientific and administrative operations. Operates, maintains, and repairs clinical laboratory equipment within scope of training including routine ... safety checks. Oversees and reviews area weekly and monthly Quality Control and maintain QC database. Set up and...up and validate new assays as assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), ... assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development… more
- Novo Nordisk Inc. (WA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership...services/tasks in support of the planning and implementation of quality driven clinical trials, in line with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(ICH) guidelines.The Manager , Study Associates will ensure the SAs provide clinical administrative support to the study teams and support interactions with the ... Organizations (CROs) and other vendors conducting the study to help monitor compliance with Quality Oversight measures. Responsible for staff training,… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at ... provides customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent...within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality … more
- Aequor (New York, NY)
- …managing change in a dynamic, complex environment. Demonstrated interest in Patient Quality and Compliance . Interview: Teams Position Comments : Preferred ... Supply Chain Business Lead (SCBL) is responsible to advance and grow the Global Clinical Supply (GCS) business of delivering clinical supplies to patients. The… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …Marketing, Area Commercial Sales Team, Medical Affairs, Legal & Compliance and Human Resources. External relationships include responsibility for multiple ... as well as the full range of treatment options available and associated clinical outcomes Leverages detailed knowledge of both Novo Nordisk and competitor products… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory ... want to hear from you. Job Summary: As the Americas IT Security and Compliance Director, you play a pivotal role in ensuring the organization's adherence to… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product ... quality , integrity and compliance with regulatory guidelines and internal/global standards and procedures....IMP as a result of distribution practices, manufacturing sites, clinical sites and testing laboratories and assures they are… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Catalent (Harman, WV)
- The Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a significant impact on the way that the Harman's site ... operates. The Manager , Supply Chain - Warehouse will lead a shift...with other functional leads to improve operational performance and compliance will be a success factor for this role.This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …difference? The Position Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...Essential Functions Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and industry-specific… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , MSAT or cell therapy. A portion ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Strategic Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating and monitoring ... ensure business objectives are met Manages and monitors organizational compliance with all established supplier agreements Provides strategic procurement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …agreements across a broad spectrum of external entities with a focus on budget, quality , compliance and in alignment with business needs Serve as a subject ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
