Associate Compliance Auditor, REMS

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔎 Auditor

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Logo of UBC

UBC

1001 - 5000 employees

Founded 2003

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

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.

📋 Description

• Provide consistent and effective communication with REMS stakeholders as first-line support and single point of contact • Maintain accurate and complete documentation of all contacts • Review audit plans, project-specific procedures, work instructions, audit questionnaires, and supporting documentation • Complete assigned audit questionnaire reviews within project audit-plan timelines • Review submitted documentation for completeness, accuracy, and REMS program compliance • Follow up on documentation deficiencies and actions according to client timelines • Communicate with stakeholders by phone or email regarding outstanding documentation • Identify, evaluate, and address audit findings • Explain audit results to stakeholders • Complete automated or manual audit review forms • Assist REMS Senior Auditors with continuous quality improvement • Record and report audit results and document corrective/preventive actions • Collaborate with REMS Associate, Auditor, and Senior Auditor teams to share best practices • Complete SOP review and client-specific training documentation within required timelines • No supervisory responsibility

🎯 Requirements

• Minimum Associate Degree required; Bachelor’s Degree preferred or equivalent work experience • Basic understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies (REMS) guidelines and FDA regulatory requirements • Proficiency in Microsoft Office suite • Strong attention to detail and analytical skills • 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

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