
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.
🔥 0 minutes ago
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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.
• Provide consistent and effective communication to REMS stakeholders, including healthcare settings, pharmacies, and wholesalers/distributors • Serve as first-line support and single point of contact with REMS stakeholders • Maintain accurate and complete documentation of all contacts • Review project-specific audit plans, procedures, work instructions, questionnaires, and supporting documentation • Complete assigned audit questionnaire reviews within project audit-plan time constraints • Review submitted documents for completeness, accuracy, and REMS program compliance • Follow up on stakeholder audit documentation deficiencies and actions according to client timelines • Identify, evaluate, and address audit findings • Articulate and explain audit results to stakeholders • Complete automated or manual audit review forms to verify REMS program requirements • Assist REMS Senior Auditors with continuous quality improvement • Formally record and report audit results and document corrective/preventive actions • Collaborate with REMS Associate Auditors, REMS Auditors, and REMS Senior Auditors to share best practices • Complete SOP reviews and client-specific training and documentation within requested timelines • No supervisory responsibility
• 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 • Ability to communicate with REMS stakeholders via phone or email • Ability to complete audit reviews and documentation within specified timelines
• 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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