- Twist BioScience (South San Francisco, CA)
- …senior management and external auditors. This role will collaborate closely with Internal Audit .Key Responsibilities:Act as a hands-on leader and SOX compliance ... on the next level of maturity strategy/roadmap and standards Work with Internal Audit on the completion of a comprehensive risk assessment, documentation, risk… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Successfully support the implementation, execution, and improvement of the internal audit process.Support the planning and execution of ... observations and follow-through to ensure satisfactory resolution and closure of each internal audit .Coordinate front room/ back room activities for health… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …strong and efficient process validations to ensure manufacturing success.Drive strong internal audit program and robust management reviews.Drive strong quality ... through risk monitoring and oversee the conformance to the QMS through internal audits and management review. In addition, the Quality Director will represent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(IRBs), and other site personnel as neededStudy-specific subject matter expert (SME) for internal audit or Health Authority (HA) questions related to medical ... for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1-3 studies (depending on assignment)… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …records, supporting test records and other ancillary support records. Will assist in the internal audit program and be a QA presence on the manufacturing floor. ... of the facility, and deviation issues Assists in performing and reporting internal and vendor audits as scheduled Participate in Regulatory Inspections Performs all… more
- Fidelity Investments (Boston, MA)
- …over Financial Reporting, and COSO frameworkBlend of Public Accounting and Internal Audit experience highly desirableProficient with accounting concepts and ... financial processes including financial statement risks and controlsProfessional certification CPA highly desired. Other relevant certifications CISA, CISSP and CIAExposure to IT Applications Controls (ITACs) and key reports (IPEs) testingExposure to ERP/GL… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies.ResponsibilitiesManages all payroll supporting processes and controls which include:Provides audit support for internal and external auditors. ... role will be responsible for managing multiple vendor relationships, internal and external auditors and payroll and tax providers....for providing key support for the annual 401K (5500) audit and ensure all deadlines are met. Regularly leads… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …adhered Engages internal and external auditors in discussion regarding relevant audit findings or recommendations and remediates as needed Own and manage testing ... service team based in Bangalore, India. Other key r0elationships include internal and external auditors, and government agencies. Essential Functions Financial close… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …tasks.Develop the performance/talent of direct reports.Schedule, staff, train, and audit multiple activities for responsibilities.Ensure completion of all testing, ... requirements important to pharmaceutical and combination drug manufacturing labs.Help with plant audit ready status efforts for assigned areas and participate in … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in close coordination with CMR stakeholders, Procurement, and Legal. Managing internal and external strategic collaborations to optimize alliance performance by ... with leaders within CMR, Legal, Procurement, Compliance, Privacy and other key internal stakeholders. In the execution of specific projects, the Associate Director,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the internal and external study teams. This may include participation in internal and ... for delivering and executing Quality Oversight aspects of our internal (DSG) GQA and R&D business functional stakeholders by...ongoing review of risks by evaluating Quality Events (QEs), audit , and inspection outcomes so these data may be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requests from study team members, periodic review of user access and audit trail reconciliation, impact analysis and documentation of identified access discrepancies ... ad hoc data reporting needs, and manage quality expectations in partnership with internal and external stakeholders, as needed. Partner with the study data managers… more
- Novo Nordisk Inc. (WA)
- …with select government agencies. Serves as a subject matter expert. Solicits internal stakeholder insights to analyze the business impact of select policy proposals ... has direct supervisory responsibility for a team of individual contributors. Other internal relationships include all other Market Access & Public Affairs teams,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Senior Clinical Study Manager will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and ... to the Operations Program Lead and study team leader.Ensure adherence to internal procedures for study planning, study conduct, close out and reporting.Proactively… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& Management within the Enterprise Data & Advanced Analytics department. Primary internal relationships are within FIES, IT, Compliance, Field Systems, and other ... ensure those changes are available to users. Work with internal and external business partners to identify data issues...on an ad hoc basis Situational analysis, documentation, and audit of current processes, data flows and systems Promote… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …and retention targets Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and ... trial site staff, clinical research vendors). Manages relationships with multiple internal stakeholders relevant to the planning and implementation of clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the risk-based central monitoring function.Interacts with and influences internal management and study level stakeholders on risk-based quality management ... internalization of RBQM and Central Statistical Monitoring activities including internal production of QTLs and visualization/tabulations to detect data oddities,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …licensing costs, and outsourced FTE. Support budget coordination and tracking, review and audit all final bills, and assist in the preparation of reports HCP ... Compliance Management: Support the management and enhancement of integrated SaaS and internal systems to ensure compliance with both internal and external… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the development and testing of clinical systems (eg, data capture, IxRS) Ensure internal and external systems are updated in a timely manner (eg, trackers, ... recruitment materials Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF Drive critical clinical trial activities including trial site… more
- Genmab (Plainsboro, NJ)
- …Global Clinical Drug Supply will work in partnership with several internal and external stakeholders, including GCDS Operations, GCDS Systems, Development ... development.Oversee resource allocation and ensure effective team planning.Regulatory and Audit ComplianceEnsure compliance with country-specific clinical supply regulations.Represent GCDS… more
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