- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU 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)
- … compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of… more
- Novo Nordisk Inc. (Miami, FL)
- …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
- Catalent (St. Petersburg, FL)
- …the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management ... Compliance ManagerPosition SummarySt. Petersburg is our primary softgel...St. Petersburg site. The Department has the responsibility for Quality aspects including but not limited to Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; ... services/tasks in support of the planning and execution of quality driven clinical trials in line with...staff and location changes and IRB/REB/regulatory approvals to assure quality of the documentation files and compliance … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....tasks performed by suppliers and business partners to ensure compliance with SDEA requirements. Relationships This position reports to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell therapy. A minimum of ... Corrective and Preventive Actions (CAPA) process, and is responsible for ensuring compliance within quality systems processes. Key Responsibilities Lead the CAPA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& Social Impact (CSSI), Alliance Development, Sales & Marketing, Procurement, IT, Compliance and Legal. Essential Functions Apply clinical knowledge and ... 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
- Catalent (Manassas, VA)
- …healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and ... help create engaging new products consumers will love.The Site Procurement Manager is responsible for procurement leadership, sourcing and procuring materials,… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... the Quality Unit and could include all or some aspects of the Quality function.The Product Development QA Manager provides quality focused customer… more
- Merck & Co. (OH)
- …process and support for our Company oncology products.- - Knowledgeable on relevant quality metrics, clinical protocols, care pathways, relative cost of care and ... Job DescriptionThe Oncology Key Account Manager is the primary Oncology point of contact...corporate personnel, medical directors in charge of provider networks, quality directors, service line leaders, pharmacy directors and financial… 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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programming is a member of the Biostatistics and Data Management ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and ... Safety staff for all marketed and investigational Eisai productsDesigns and conducts quality reviews to verify the accuracy, completeness and validity of information… 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
- Aequor (Piscataway, NJ)
- Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule: West Chester.PA (hybrid) Is this temp to perm? The manager intends to convert the ... FTE after a year Shift Type: Day M-F 9-5 Position Summary: The Manager /Sr. Manager , Medical Communications (S/MMC) supports publication strategy and plan… more
