REMS Compliance Auditor

🕒 August 26

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🔎 Auditor

👻 Ghost score 30%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 all interactions • Review project-specific documentation, including audit plans, procedures, and work instructions • Complete timely reviews of assigned audit questionnaires according to project deadlines • Conduct document reviews for completeness, accuracy, and compliance with REMS program standards • Follow up on audit documentation deficiencies and actions within client timelines via phone or email • Identify, evaluate, and address audit findings and communicate results to stakeholders • Complete audit review forms to verify adherence to REMS program requirements • Record and report audit results and document corrective and preventive actions • Collaborate with REMS Auditors to share best practices • Complete SOP reviews and client-specific training within specified timelines • Assist in developing project-specific audit plans, procedures, and work instructions • Assist in training REMS Associate Auditors in program audit techniques • Maintain professional communication with organizational levels, clients, sponsors, and regulatory authorities • Manage multiple tasks and priorities according to business needs • Conduct on-site audits as requested by clients • Support the Global Quality Compliance team with client and regulatory audits when needed

🎯 Requirements

• Minimum Associate Degree required; Bachelor’s Degree preferred or equivalent work experience • 1-2 years of experience in pharmacy auditing, compliance, or a related field within the pharmaceutical and/or healthcare industry • 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

🏖️ 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