- CoxHealth (Lake Spring, MO)
- …:The position is responsible for auditing medical records, reviewing hospital charges and documentation to ensure compliance with payer regulations, coding ... conventions, and hospital policies. RN auditors are also responsible for educating employees, physician, and patients and others for billing compliance.Education: ▪ Required: Graduate of an accredited nursing program ▪ Preferred: Bachelor's Degree in Nursing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company Corporate Audit and Assurance Services' (MCAAS) primary purpose is to provide value-added independent and risk-based audit and ... divisions and functions to evaluate the adequacy of internal controls and deliver audit reports that add value to the area audited.Coaches, mentors and trains staff… more
- Merck & Co. (Rahway, NJ)
- …to what is described in the Pipeline Advertisement.Expand your skills and experience in audit through a career path in the pharmaceutical industry. Become part of a ... a positive impact on patients' lives.Under the direction of the Client Audit Director (CAD) and the Auditor-in-Charge (AIC), the Senior Specialist will:Participate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Audit and Assurance Services primary purpose is to provide value-added independent and risk-based audit and assurance ... Overview / Function and ResponsibilityUnder the direction of the Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the Senior Specialist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi ... appropriate for the area of GxP audits assigned.Responsibilities:Execute the audit program for internal systems as applicable for the...of GxP audits assigned in alignment with the Master Audit Schedule using a risk-based approach to ensure the… more
- Insmed Incorporated (NJ)
- …Are you?About the Role:We are seeking a highly motivated and expert Executive Director, Internal Audit & SOX (ED, IA) to lead our internal audit function and ... control environment. Reporting directly to the Audit Committee of the Board of Directors and administratively to the Chief Financial Officer, the role will be… more
- Cipla (Hauppauge, NY)
- …IT systems supporting manufacturing processes, with a particular focus on audit trail review, data integrity, and overall GxP compliance. Responsibilities: Perform ... detailed reviews of the equipment audit trails associated with batches during production. Verify that...process. Investigate any discrepancies or unauthorized actions in the audit trails and escalate as needed. Review user activity… more
- Jazz Pharmaceuticals (Redwood City, CA)
- …responsible for the execution of issue management processes, assisting and/or leading audit and inspection processes and preparing for governance meetings to achieve ... compliance, inspection readiness, and continuous improvement across the Regulatory and Labeling organizations. Essential Functions/Responsibilities Responsible for all aspects of day-to-day issue management, communication, and escalation, CAPA resolution,… more
- Jazz Pharmaceuticals (San Jose, CA)
- …technical solutions align with business requirements and stakeholder needs. Ensure audit preparedness and support regulatory inspections for REMS. Support daily ... departmental tasks to meet REMS requirements for multiple products. Required Knowledge, Skills, and Abilities A minimum of 6-8 years of experience in the pharmaceutical industry, including at least 3-5 years in data programming, with a focus on REMS programs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …all sites.Manage and support the implementation of the internal and external audit program.Schedule, execute, report and follow-up on internal and US and Global ... external audits (travel required).Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and procedures as well as… more
- Formation Bio (New York, NY)
- …Drafts and maintains technical accounting memos and white papers for audit and investor purposes Assesses accounting implications of proposed deal structures ... Coordinates with external auditors on technical accounting conclusions and audit support Biotech-Specific Accounting Expertise Oversees application of GAAP to… more
- Tris Pharma (Monmouth Junction, NJ)
- …transactions while implementing rigorous controls to reduce errors and support audit readiness including, but not limited to: overseeing and supporting daily ... and documentation; Drafts white papers and accounting memos to support audit and regulatory compliance Provides guidance on new accounting pronouncements, as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …transfer of PV Business in case of Product Divestment. Collaborate with DSI audit groups to ensure comprehensive auditing of Business Partners as required to assure ... compliance with PV agreements. Participate in audit and inspection readiness activities. Provide input for remediating PV system deficiencies cited in audit… more
- Cipla (Hauppauge, NY)
- …and other documents related to manufacturing processes. Ensure batch records are audit -ready and fully compliant for both internal and external audits (eg, FDA, ... GMP inspections). Assist audit teams by providing required batch documentation and responding...teams by providing required batch documentation and responding to audit queries related to manufacturing processes and batch records… more
- Merck & Co. (Rahway, NJ)
- …customer requirements, SOPs and project specific guidelines/ instructions.Evaluate audit findings and ensure timely identification/ escalation of potential ... Quality Head at a USDA governed siteRequired Skills: Animal Health Care, Audit Inspections, cGMP Regulations, GMP Auditing, GMP Compliance, GMP Operations, Good… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness Support the preparation and execution of internal and ... audits and regulatory inspections Ensure documentation and processes are audit -ready and aligned with global pharmacovigilance standards Physical Requirements 0-10%… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Aggregate Spend data and timeliness associated with the reports including the 100% audit of all HCP engagements. Additionally, this position will be responsible for ... of errors within predetermined timelines. Accountable that all meeting audit folders are complete and 100% accurate. Accountable that...that HCP spend data is 100% accurate by conducting audit of data and meeting folders. Educate stakeholders, if… more
- BioAgilytix (Durham, NC)
- …the last mile: turning those clean, validated data streams into the audit -ready files our pharmaceutical sponsors need on tight deadlines. You'll harmonize results ... to sponsors.Automate Delivery Workflows: Leverage RPA, scripted edit checks, and audit -trail capture to shrink cycle times and reduce defects.Enable Self-Service… more
- Eisai, Inc (Nutley, NJ)
- …and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality ... Clinical Quality Assurance (CQA) strategy for the country/region in scope (including audit and inspection management, issue management, and oversight of the quality… more
- Cipla (Hauppauge, NY)
- …set standards to meet the regulatory requirement and to ensure audit readiness Ensure proper receipt, verification, segregation, storage, labelling and accounting ... and issuance Maintain sanitation and hygiene in stores facility to ensure audit readiness Ensure correct status labelling for materials, accessories and equipment by… more
