- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Leadership:Has primary accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and...study budget is reconciled with Finance on an ongoing basis. Support all inspection readiness and quality initiatives… more
- Genmab (Plainsboro, NJ)
- …development.Oversee resource allocation and ensure effective team planning.Regulatory and Audit ComplianceEnsure compliance with country-specific clinical supply ... areas for improvement and drive process enhancements.Align GCDS efforts with Quality Assurance, Clinical Strategy, and other stakeholders.Address drug supply… more
- Genmab (Plainsboro, NJ)
- …compliance during all drug supply planning tasks, activities, and deliverablesGlobal Clinical Drug Supply: Support development and maintenance of SOPs for ... and resolution of deviations, CAPAs and change controls in connection to Clinical Drug Supply OperationDrive Inspection and Audit preparation and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Successfully support the implementation, execution, and improvement of the internal audit process. Support the planning and execution of internal audits for ... quality system areas for the manufacturing site; write audit reports, issue audit observations and follow-through...process, and control access to any systems used to support audits/inspections.Provide support to quality … more
- Aequor (Thousand Oaks, CA)
- …the enterprise (R&D, Operations, and GCO). In this vital role you will support the quality management system team to provide proactive compliance oversight ... Quality Management System organization. Under general supervision, provide tactical support activities to Quality Management System Lead. Specific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deriving from these contracts. Organize and conduct periodic review of contract quality and adherence. Support business functions in determining PV relevance ... to Health Authorities and License Partners, Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …risk-based monitoring (RBM) and Central Monitoring.Responsibilities:CRA Monitoring Oversight Management: Support monitoring oversight strategy to ensure quality ... against. Metrics and Analytics:Ability to analyze data/metrics/key performance indicators to support vendor/CRO oversight of CRAs in clinical trials.Contribute… more
- Merck & Co. (Rahway, NJ)
- …team.Ensure inspection readiness and offer prompt support during regulatory, quality , and safety inspections.Address audit findings and identify trends to ... compliance metrics and report the observed trends to senior management.Provide regulatory support by preparing or reviewing high- quality CMC sections for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based in Raritan, NJ. Role OverviewThis position will be responsible for providing support to implement and maintain computerized systems in the cGMP Clinical ... project execution and management, vendor management, data life cycle management, Quality events, remediation and improvement efforts of computerized systems for… more
- BrightSpring Health Services (Louisville, KY)
- …of Clinical Denials Management and Audit supervises a team of RN/LPN clinical reviewers as well as Support staff managing all areas of clinical ... training, and ensure the denial department provides subject matter expertise around clinical denial management. This position will also support detailed level… more
- The Cigna Group (St. Louis, MO)
- …+ This role leads Supervisors and/or managers of clinical quality , non- clinical quality and Behavioral External Audit teams. The Sr. Manager is ... compliance with industry regulations. This role will oversee onshore clinical and non- clinical quality teams...external audit team, collaborating with Medical External Audit team and external consultants to support … more
- Fujifilm (College Station, TX)
- …+ Work with Quality management to ensure quality systems support cGMP manufacturing of pre- clinical to commercial products. + Compliance + Ensure ... current standards + Execute audit strategy and lead process audits + Monitor quality in support of maintaining inspection readiness + Provides support … more
- HCA Healthcare (Nashville, TN)
- …HCA Healthcare colleagues invested over 156,000 hours volunteering in our communities. As a Coding Quality Audit Reviewer with Work from Home you can be a part ... Plan with 10% off HCA Healthcare stock + Family support through fertility and family building benefits with Progyny...our organization. We are looking for an enthusiastic Coding Quality Audit Reviewer to help us reach… more
- Eurofins (Lancaster, PA)
- …managing executions in the region and participating as a member of the global audit management team to support audit activities across global markets. ... support inquiries and provides subject matter expertise to support audit service delivery in key execution...of social compliance auditors consistent with APSCA requirements + Support application of global quality and integrity… more
- HCA Healthcare (Nashville, TN)
- …particularly focusing on complex audit issues. * Participates in the audit quality assurance program. * Assists with educational and administrative matters ... as well as corporate responsible personnel to help effect overall compliance. The Clinical Compliance Audit Manager position will work on various audit… more
- Bon Secours Mercy Health (Columbia, SC)
- …audits according to the audit plan and develops appropriate documentation to support audit work performed. + Measures and tracks the results of audits ... Bon Secours Mercy Health, we are dedicated to continually improving health care quality , safety and cost effectiveness. Our hospitals, care sites and clinicians are… more
- Hartford HealthCare (Farmington, CT)
- …contractual, professional standards and healthcare revenue cycle industry practices. The audit and education specialist will support documentation practices that ... of Connecticut's most comprehensive healthcare network. The creation of the HHC System Support Office recognizes the work of a large and growing group of employees… more
- Charles River Laboratories (Wilmington, MA)
- …development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. ... passionate about. **Job Summary** We are seeking an **Internal Audit Intern** for our Corporate site to be located...locations. + Follow established standards to document workpapers in support of engagements. + Participate in interviews of key… more
- Fallon Health (Worcester, MA)
- …among the nation's top health plans for member experience, service, and clinical quality . We believe our individual differences, life experiences, knowledge, ... summary of purpose:** Under the general direction of the Senior Internal Audit Manager, theAnalyze and interpret patient medical records pertaining to FWA… more
- American Heart Association (Dallas, TX)
- …can be home based. The **Compliance Audit and Program Manager** ensures clinical data quality , program compliance, and operational integrity for the American ... (formerly Twitter), and at heart.jobs. **Responsibilities** + Plan, coordinate, and execute clinical data quality audits to ensure the integrity and credibility… more
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