Associate REMS Auditor - Fixed-Term

March 26

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UBC

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UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

Evidence Development • Modernized Study Design & Execution • Late-Stage Research • Risk Evaluation & Mitigation Strategies • Pharmacovigilance

1001 - 5000 employees

Founded 2003

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• The Risk Evaluation and Mitigation Strategy [REMS] Associate Auditor provides core compliance functions and project support for the REMS Stakeholder audit group. • Audit support includes, but is not limited to, communication with stakeholders [healthcare settings, pharmacies, wholesalers/distributors], review of audit questionnaires and audit supporting documentation and appropriate documentation within the project-specific application. • Provide consistent and effective communication to all appropriate stakeholders as first line support/single point of contact with REMS stakeholders [healthcare settings, pharmacies, wholesalers/distributers]. • 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. • Identifies, evaluates, and addresses 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 completes SOP review and documentation within requested timelines. • Consistently completes client specific training and documentation within requested timelines.

🎯 Requirements

• Minimum Associate Degree require; Bachelor’s Degree preferred or equivalent work experience • 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 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

🏖️ Benefits

• Remote opportunities • Competitive salaries • Growth opportunities for promotion • 401K with company match* • Tuition reimbursement • Flexible work environment • Discretionary PTO (Paid Time Off) • Paid Holidays • Employee assistance programs • Medical, Dental, and vision coverage • HSA/FSA • Telemedicine (Virtual doctor appointments) • Wellness program • Adoption assistance • Short term disability • Long term disability • Life insurance • Discount programs