- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end ... Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the...on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data … more
- Tris Pharma (Monmouth Junction, NJ)
- …and/or leads, key Drug Safety activities including, but not limited to: safety data review, signal detection, risk communication including safety ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director ,...periodic benefit risk evaluation reports, etc.) Oversees reconciliation of safety data in pharmacovigilance and clinical trial… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality ... Japanese, and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and … more
- Insmed Incorporated (Bridgewater, NJ)
- … Safety Management Plans. Directs the compilation and interpretation of safety data for reporting purposes, including marketing applications to regulatory ... to ensure compliance with company policies and regulatory requirements on safety data reporting, collection, surveillance activities and documentation and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time.- Coordinate ... areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product...as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other relevant sources… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management, CAPA tracking, change control, risk management, supplier quality , audits and inspections, raw materials release, and compiling, trending and reporting… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as liaise with business development and other strategic business cases Reviews and evaluates the quality of data and new data sources used in analyses, ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Tris Pharma (Monmouth Junction, NJ)
- …not limited to: Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, ... immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical Operations provides expert… more
- Merck & Co. (Rahway, NJ)
- …proteomics, metabolomics), patient-level data , compound libraries, chemical structures, safety data , and analytical results.Develop data integration ... efficient and seamless access to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy,… more
- Merck & Co. (Rahway, NJ)
- …with a matrixed reporting relationship to functional groups in development, quality , safety , facilities management, analytical, finance and regulatory.-FLEx was ... and behavioral dimensions.Member of site and global leadership committees (eg safety , quality ).Education:BS or MS degree in Chemical Engineering, Biochemical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on ... include: develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …registrational studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the drug project; Leads the planning and analysis of integrated efficacy and safety data ; Review the relevant sections of the electronic common technical ... leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, ... users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data ... including advocating for good data governance, stewardship, data identification, and data quality ...legal, compliance, IT security, etc.Responsibilities- In conjunction with the Director of Data Stewardship, Cataloging and Process,… more
- Catalent (San Diego, CA)
- …capabilities.Perform internal and external audits.Lead or support client audits along with the Director and Associate Director of Quality AssuranceManage a ... preventative maintenance certificates of laboratory and manufacturing equipment.Point person for safety complaints and improvements in the Quality Assurance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as a liaison between NNI Patient Safety Group and other departments on Safety Data Exchange Agreement (SDEA) related matters. To contribute and support ... review and negotiation, management of SDEA requirements, and supplier relations Oversees safety data reconciliation and QC activities from suppliers and… more
