- Merck & Co. (Rahway, NJ)
- …testing for all the objects developed participate in the Integration testing, Resolve the issue and coordinate to resolve the issue with offshore team. Create & ... maintain all deliverable Documents. Required Education Level:-Bachelor's Degree required. Prefer major in Computer Science or Information Technology.Required Skills & Experience:-Minimum of 10 years of relevant experience. SAP ABAP, OOABAP, CDS, OData… more
- Insmed Incorporated (Bridgewater, NJ)
- …MAAs, PIPs, Scientific Advice, annual reports, and briefing documents).Contribute to issue -resolution teams, driving the scientific approach for toxicology issue ... resolution.Provide impurity safety assessment in support of CMC manufacturing and/or registration.Contribute to department SOPs and best practice documents.Qualifications:DVM, Ph.D., or equivalent in Toxicology or a related discipline. DABT/DACVP certification… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Support the creation of automated, scalable approaches for data quality issue identification, support mitigation, the development and implementation of data quality ... functional areas and technology stakeholders to resolve data conflicts, process issue , and oversee the implementation and documentation of the appropriate governance… more
- Aequor (Seattle, WA)
- …support cross-site material transfers management, facilitate & drive troubleshooting/ issue resolution, drive continuous improvement initiatives, and decision-making ... all levels of the organization. Strong motivation & self-drive to achieve issue resolution, in a collaborative manner Strategic thinking ability to translate… more
- Aequor (South San Francisco, CA)
- …lab-based investigation to address target safety assessment, lead optimization, and issue mitigation by employing state-of-the-science in vitro and ex vivo ... approaches. As such, we are constantly establishing new platforms and technologies to support a constantly changing portfolio, Client modalities, and emerging therapeutic area needs. We are looking for a highly motivated candidate to work in collaboration with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manage change when necessary to meet risk assessment outputs. Lead issue oriented Risk Assessment meetings; mediate and resolve conflicts; and drive teams ... to success. Follow-up on action items between team meetings and ensure accountability of team members. Interface with all levels of management and ensure alignment throughout the organization. Be a model of superb organization, excellent timeliness and… more
- Aequor (Athens, GA)
- …above) against cGMPs to assure real time observation of activities, issue identification/ resolution including proper and timely documentation. Provides guidance to ... and may escalate to senior management team based on severity of the issue . Responsible for providing quality oversight to the change management system for complex… more
- Merck & Co. (North Wales, PA)
- …development of responses and implementation of corrective and preventative actions.-Develop and issue Animal Health Quality Actions to all sites and functional areas ... based on issues originating from a variety of sources including Human Health Quality Bulletins/Directives as applicable.Collaborate with global Animal Health sites and functional areas to implement changes required by Quality Actions and to ensure all related… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …are critical production issues, the candidate leads the process of identifying the issue , analyzing the cause, designing and implementing the solution until the ... issue is fixed. Relationships This position reports to Associate Director of Web Technology Platform Development and Operations in Information Technology and… more
- Insmed Incorporated (Bridgewater, NJ)
- …PIPs, Scientific Advice, annual reports, and briefing documents). Contribute to issue -resolution teams, driving the scientific approach for toxicology issue ... resolution.Provide impurity safety assessment in support of CMC manufacturing and/or registration. Contribute to department SOPs and best practice documents.QualificationsDVM, Ph.D., or equivalent in Toxicology or a related discipline. DABT/DACVP certification… more
- Tris Pharma (Monmouth Junction, NJ)
- …and risk management across outsourced clinical trials, ensuring efficient issue resolution, risk mitigation and continuous improvement through strategic partnerships ... with Clinical Research Organizations (CROs) and vendors across all phases of drug development; Ensures compliance with established clinical and regulatory guidelines, operating systems and procedures in clinical trials and maintains Clinical Operations… more
- Merck & Co. (North Wales, PA)
- …take a lead role in monitoring vendor performance and facilitating issue resolution.Effectively plan and manage publication planning budget, providing updates to ... management.Ensure that medical/scientific publication activities comply with the International Committee of Medical Journal Editors Recommendations, the Consolidated Standards of Reporting Trials (CONSORT), and Good Publication Practice for Pharmaceutical… more
- Insmed Incorporated (Bridgewater, NJ)
- …in a matrix organization, driving decision making, facilitating issue resolution, problem-solving, risk management, contingency planning and decision-making.Lead ... and direct integrated teams to plan, execute, control, report and close-out all program related work across all functions (eg, integrated program budget, risk, timeline, resource, and stakeholder management).Other projects and assignments, as… more
- Merck & Co. (Austin, TX)
- …internal and third-party vendor business partners.-Coordinate operational and project timelines, issue and risks based on the global program critical initiatives and ... goals.-Collaborate and implement standards covering Agile, Waterfall or Hybrid Project methodologies.-Partner with Product Managers to provide clarity on the business and technical requirements to drive the appropriate user stories and sprint planning.-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Managers to oversee quality of external data, transfer standards, and issue management. Ensure consistency of standard implementation across programs. Is accountable ... for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements. Participates in audits as an external data management subject matter expert and provides… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …contracts / SOWs and budgets for desired services Field Engagement & Issue Management Builds and maintains trusting, collaborative relationships and alliances with ... internal and external partners, focused on addressing key business issues, objectives, and processes Works closely with Sales, Marketing & Market Access teams to ensure the successful execution of high-impact program strategies that support patients… more
- Merck & Co. (Washington, DC)
- …and working with stakeholders via direct relationships, coalitions, and trade associations. Issue areas covered may include but are not limited to animal health, ... one health and zoonoses, animal welfare, sustainability, animal traceability, biotechnology, precision agriculture, animal monitoring, and veterinary telehealthThis role will also have responsibility for leading the development and execution of public policy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including SOW development, budget management, performance management and ad hoc issue resolution Partner with IT organization to ensure Novo Nordisk develops ... the technological requirements to support execution of current and future Digital initiatives Key contributor to overall Digital strategy and roadmap capabilities for patients that successfully builds profitable, long-term programs Develops and encourages… more
- Novo Nordisk Inc. (Boulder, CO)
- …and follow-through Working with other departments in Lexington and Denmark for issue resolution Working with the team to generate presentations with committee to ... upper management Managing input from Boulder site employees Physical Requirements Percentage of Travel: 10%. Qualifications Education: BS degree in a science discipline. Advanced degree in the Life Sciences or related field preferred. 5+ years of relevant… more
- Aequor (New Brunswick, NJ)
- …identifies and resolves technical problems. Assist in project communications; issue straightforward communications to limited audiences. Work under supervision in ... coordinating specific components and project work activities. Assist in assuring effective transition into production as appropriate. Manage simple tasks and provide activity coordination assistance. Manage issues in a reactive fashion. Accurate communications… more
