Associate REMS Auditor

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔎 Auditor

👻 Ghost score 10%

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 consistent and effective communication to all appropriate REMS stakeholders as first line support/single point of contact • Maintain accurate and complete documentation of all contacts • Review project-specific documentation, including audit plans, procedures, and work instructions • Complete assigned audit questionnaire reviews within project audit-plan timelines • Review submitted documentation for completeness, accuracy, and REMS program compliance • Follow up on stakeholder audit documentation deficiencies and actions according to client timelines • Communicate via phone or email regarding outstanding documentation • Identify, evaluate, and address audit findings • Articulate and explain audit results to stakeholders • Complete automated or manual audit review forms accurately • Assist REMS Senior Auditors with continuous quality improvement • Ensure audit results are formally recorded and reported, including corrective/preventative actions • Collaborate with REMS Associate, Auditor, and Senior Auditor teams to share best practices • Complete SOP review and documentation within requested timelines • Complete client-specific training and documentation within requested timelines • Support compliance functions and projects for the REMS Stakeholder audit group

🎯 Requirements

• Minimum Associate Degree required; 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