Audit Manager

4 weeks ago

Batangas City, Philippines SYSGEN RPO Full time

Audit Manager - REMS (Risk Evaluation and Mitigation Strategy) - Remote / US The Risk Evaluation and Mitigation Strategy (REMS) Manager Auditor provides core compliance functions and project support for the REMS Stakeholder audit group. Audit support includes communication with stakeholders (healthcare settings, pharmacies, wholesalers/distributors), review of audit questionnaires and supporting documentation, and appropriate documentation within the project-specific application. Specific job duties: Provide consistent and effective communication to all appropriate stakeholders as first line support/single point of contact with REMS stakeholders (healthcare settings, pharmacies, wholesalers/distributors). People Management role to handle all Managerial tasks and POC for Clients. Maintain accurate and complete documentation of all contacts. Review project specific documentation that may include audit plans, project specific procedures, work instructions. Complete review of all audit questionnaires assigned within the time constraints listed in the audit plan for a specific project. Conduct document review of submitted documentation for completeness, accuracy, and REMS program compliance. Ensure follow-up of stakeholder audit documentation deficiencies and actions per client timelines. Communicate with stakeholders via phone or email for documentation still outstanding. Identify, evaluate, and address any audit findings. Articulate and explain audit results to stakeholders. Accurately complete the audit review form, either automated or manual, to ensure that documentation has been provided that meets the REMS program requirements. Assist in development of continuous quality improvement with REMS Senior Auditors. Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented. Work collaboratively with other REMS Associate Auditors, REMS Auditors and REMS Senior Auditors to ensure that best practices are shared. Consistently complete SOP review and documentation within requested timelines. Consistently complete client specific training and documentation within requested timelines. Supervisory Responsibility: Yes Desired Skills and Qualifications: Bachelor’s Degree preferred or equivalent work experience. 7+ years experience in similar roles. Supervisory/Lead experience (must). Strong attention to detail and analytical skills. Basic understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies (REMS) guidelines and FDA regulatory requirements. Proficiency in Microsoft Office suite. Strong organizational, people management and time management skills. Willingness to learn and adapt to new processes and regulations. Ability to work efficiently and prioritize tasks effectively. Strong problem-solving abilities. Adherence to ethical standards and confidentiality protocols. Ability to maintain composure and professionalism under pressure. Willing to work US shift. Seniority level Mid-Senior level Employment type Full-time Job function Accounting/Auditing Industries Pharmaceutical Manufacturing #J-18808-Ljbffr

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