Senior REMS Compliance Auditor – Supervisor

🔥 8 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔎 Auditor

👻 Ghost score 10%

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UBC

WebsiteLinkedInAll Job Openings

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 effective communication to relevant stakeholders as the primary point of contact for REMS stakeholders in healthcare settings, pharmacies, and wholesalers/distributors • Maintain thorough and accurate documentation of interactions • Review project-specific audit plans, procedures, work instructions, questionnaires, and supporting documentation • Complete timely reviews of assigned audit questionnaires • Conduct document reviews for completeness, accuracy, and compliance with REMS program standards • Follow up on audit documentation deficiencies and actions via phone or email • Identify, evaluate, address, and communicate audit findings • Complete audit review forms verifying adherence to REMS program requirements • Assist with continuous quality improvement efforts • Record and report audit results and corrective and preventive actions • Collaborate with REMS Auditors to share best practices • Complete SOP reviews and client-specific training • Develop project-specific audit plans, procedures, and work instructions • Provide program audit training to REMS Associate Auditors • Maintain professional communication with clients, sponsors, and regulatory authorities • Manage multiple tasks and priorities according to business needs • Guide audit teams in addressing findings and contribute to quality improvement with REMS Management and Project Management • Conduct on-site audits as requested by clients • Support the Global Quality Compliance team with client and regulatory audits • Supervise up to five direct reports

🎯 Requirements

• Bachelor’s Degree preferred • At least three (3) years of experience in pharmacy auditing, compliance, or a related field within the pharmaceutical and/or healthcare industry • Strong understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies [REMS] guidelines and FDA regulatory requirements and industry standards • Ability to work independently without supervision • Strong attention to detail and analytical skills • 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 • Willingness to travel up to 10%

🏖️ 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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