- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position This role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing four functional areas: Policies & ... a critical part in designing and driving the core risk management operations of the E&C team, ensuring the...as needed, to support CECO reporting to internal and external stakeholders Oversees the management and enhancement of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …completion of corrective and preventive actions, as necessary.Supports internal/ external audits.Supports Quality risk assessment teams.Review/approve documents ... as a Quality on the Floor Subject Matter Expert (SME).Remain current in skills and industry trends.RequirementsMinimum of a Bachelor's Degree in Science, Information Science or equivalent technicaldiscipline is required.Minimum of 6 years relevant work… more
- Merck & Co. (Rahway, NJ)
- …the preparation of API across internal sites and in collaboration with external partners. Proactive resourcing planning, risk assessment strategies and budget ... candidates for preclinical development.The Director establishes, recommends, and maintains external contacts for Process Research & Development, particularly locally… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(E&C) program by strategically identifying, assessing, and mitigating the organization's top risk areas. The role serves as the lead Ethics & Compliance Business ... presentations to respective customer groups. The role is pivotal in driving strategic risk mitigation efforts in alignment with the E&C's risk assessment,… more
- Aequor (South San Francisco, CA)
- …ultimate goal of driving data-driven decision-making throughout the study lifecycle. The Risk Based Quality Management (RBQM) Data Analyst sits in the Data ... limited to the development and maintenance of reports for study specific Key Risk Indicators (KRIs) and Quality Tolerance Limit parameters (QTLs). The RBQM Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at least ... 3/4 program.This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SUMMARYProvide support to the Global and Regional Quality Leads, External Partner Quality Leads, and Business Partner Quality Leads based on ... GCP compliance matters raised to the GQLs and/or RQLs from the internal and external study teams. This may include participation in internal and external … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1-3 studies (depending on assignment) with ... and presentation of clinical study(ies) data to internal and external stakeholdersProvides medical/scientific training on compound/disease and dose modifications/discontinuations… more
- Twist BioScience (South San Francisco, CA)
- …IT and SOX stakeholder groups in driving and coordinating audit requirements.Support risk assessments, planning, execution and reporting of SOX and internal audit ... review on control documentation including narratives, process flowcharts and risk and control matrices.Perform control assessments, including identifying and… more
- Twist BioScience (South San Francisco, CA)
- …remediation initiatives, and communicating compliance status to senior management and external auditors. This role will collaborate closely with Internal Audit.Key ... identifying gaps in key controls and design a proactive risk assessmentPlan and manage direct activities of the team...with Internal Audit on the completion of a comprehensive risk assessment, documentation, risk mitigation guidance, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy and study management activities and manage cross-functional study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure ... basis to study and program teams. In collaboration with internal and external partners, identify, qualify, manage, and maintain relations with clinical trial sites,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pricing, personal injury), government investigations, product complaints, and risk mitigation/reporting for Novo Nordisk Inc. Provides strategic support ... with government agencies, law firms, trade organizations and other external agencies. Essential Functions Strategically manages assigned litigation and investigation… more
- Merck & Co. (Rahway, NJ)
- …and commercial development. Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including Novo Nordisk Canada and Novo Nordisk US-based research affiliates. External relationships include vendors and consultants as well as developing and ... across NAO, aligned to executing E&C strategy and initiatives, and responding to risk Develops communications plans to disseminate information to E&C Team, the US… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …plans across functional teamsDefines the interdependent deliverables and ensures that quality, risk , cost, time are managed within the overall approved plan to drive ... criteria for the project.Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and implications… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Director (AD) is responsible for structuring facilitating and monitoring external -facing agreements including, but not limited to, Master Service Agreements ... with CMR stakeholders, Procurement, and Legal. Managing internal and external strategic collaborations to optimize alliance performance by building relationships,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of good engineering practice (GEP) industry standards, science and risk -based verification requirements and is required to supply support/technical knowledge ... of the GEP program and validation standards based on risk -based practices as prescribed in ASTM E2500. Also, will...action plans based on the results from internal or external audits, CAPA and exception management processes Performs all… more
- Merck & Co. (North Wales, PA)
- …Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our ... relevance and medical accuracy of data/information in promotional materials, external communications and field-based employee training. The Medical Affairs teams… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …HR operations within the organization. By exercising financial prudence, identifying risk areas, and maintaining transparent reporting, the role supports the ... manage financial tracking, reconciliation and goods receipts with all external vendors requiring need to validate external ...-1 for monthly review and quarterly POLT Ops Identify risk areas and contribute to the development of remediation… more
- Merck & Co. (Rahway, NJ)
- …serves as the primary GCS point of contact to stakeholders both internal and external to GCS and serve s as the GCS spokesperson at clinical development related ... products and non-of our Company marketed products . Analyzes and anticipates project risk s as they relate to clinical supply chain deliverables and prepares ,… more
