- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational ... quality management and inspection management activities.The CQOM will oversee headquarters clinical quality operations and support clinical trial teams… more
- Merck & Co. (Rahway, NJ)
- …This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of ... protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... multiple and complex cross-functional projects with many stakeholders.Support other quality systems activities, as needed.Support drafting, review and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , technical ... operations or cell therapy.Experience with quality support in clinical manufacture is preferred.Flexible to work on weekends, as needed.Needs to be mobile and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriate, data delivery and reporting.Accountable for the effective support of clinical activities within the Development organization.Ensure a " Quality ... staff and to project teams for Vendor evaluation, selection , management and quality based oversightProvide guidance and training to Clinical Operational members… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigation Lead is an… more
- Aequor (Thousand Oaks, CA)
- …support to Global Supply Planners and Logistics Service Providers - Partner with clinical site staff and Quality to document, investigate, and communicate ... (POR) - Support reconciliation and return of investigational products Temperature Data & Quality : - Review shipment temperature data and assess excursions with … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment....tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Review and approve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams providing the safety leadership and serving as the primary point of contact. Review and analyze data from clinical trials, post-marketing and other relevant ... around rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the quality and timeline of vendor workoCollaborate with study clinical or medical lead and biostats to ensure availability of necessary dataoCoordinate ... study investigators- Manage vendor budget and activities- Oversee the quality and timeline of vendor work- Collaborate with study... and timeline of vendor work- Collaborate with study clinical or medical lead and biostats to ensure availability… more
- Aequor (Irvine, CA)
- Job Description: Major Accountabilities: Review and investigate assigned technical and clinical customer complaints. Perform hands-on technical investigations ... and completes associated technical documentation Assist complaint intake group through review and verification of initial complaint coding. Monitor post-market and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions in a timely manner through appropriate forums, such as Quarterly Quality Reports (QQRs) and Quality Review Boards (QRBs).Collaborate with ... QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality … more
- Merck & Co. (North Wales, PA)
- …projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and other company Research ... Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical...to ensure that the data evaluated are in high quality and satisfy analysis requirements.Collaborates with the statistical programming… more
- Novo Nordisk Inc. (Forrest City, AR)
- …assess, create and maintain advocacy of customers aligned to company, brand and clinical goals. The OCS develops local strategies and executes local tactical plans ... partners. The OCS also assists their customers with their local clinical and educational initiatives by coordinating company resources (eg, counterparts, materials,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data review and cleaning, database lock), to ensure data quality /integrity and regulatory compliance- Ensures that Data Management Plans are consistent and ... development of group members and also monitors trends in functional performance via quality , time, and cost indicators, and develops plans and leads the execution… more
- Insmed Incorporated (San Diego, CA)
- …regulations, regional guidance documents and ICH guidance documentsRegulatory writing and/or review of documents supporting product development and clinical ... to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute ... and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received… more
- Merck & Co. (Philadelphia, PA)
- …partner.-Leads / supports our manufacturing division cross-functional team (Supply Chain, Quality , Technical Ops, Procurement ) who are responsible for delivering ... products.Is accountable for operational related activities such asEnsuring compliance ( Quality Risk management, Deviation Management, Product Release, Change Control);… more
- Merck & Co. (Rahway, NJ)
- …leads research and scientific field medical capabilities in alignment with Global Clinical Trial Operations (GCTO) and the broader Global Clinical Development ... in the TA, including knowledge of national/international treatment guidelines, quality measures, and collaboration networks, supporting strategic planning and… more
- Merck & Co. (San Diego, CA)
- … review and approval for IND/CSA submissions to enable clinical trial initiation.Participate in regulatory due diligence activities for in-licensing ... preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation.Interact independently with regulatory… more
