- 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 and ... centered around rare diseases and immune disorders. Summary The Director , Clinical Safety , will be a product...serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other relevant sources… more
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Develop and maintain a comprehensive understanding of patient support program data , including data sources, data quality , data governance, and ... 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)
- …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
- 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
- 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
- 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)
- …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)
- …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)
- …interpretations, eg language for IB; Documents ongoing MM review of data for safety (with CSPV) and quality at project levelStudy Strategy: For Phase 2 and ... CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/ data during study conduct, Provides and...the strategic direction to BDO for EDC, edit checks, data quality listings, SAP, DM plan, Reviews… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety information for all Novo Nordisk products. Relationships Reports to Associate Director - Patient Safety - Training. Internal relationships include all ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...product use and disease state knowledge) Develop and maintain quality check-points to track and evaluate Patient Safety… 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)
- …commitments and the goals of the new solution Define standards and metrics for quality and stakeholder satisfaction and monitor data to improve service levels ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in… more
