UBC · 11 hours ago
REMS Compliance Auditor
United States
Full-time
Remote
Entry Level
1+ years expUBC is a pharmaceutical support industry leader devoted to empowering health solutions for a better tomorrow. The REMS Compliance Auditor provides core compliance functions and project support for the REMS Stakeholder audit group, ensuring the smooth execution of audits while maintaining compliance standards and effective communication with stakeholders.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
Consistently provide effective communication to all 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 as per project deadlines
Conduct document reviews to ensure completeness, accuracy, and compliance with REMS program standards
Ensure timely follow-up on audit documentation deficiencies and actions as per client timelines, communicate via phone or email for outstanding documentation
Identify, evaluate, and address any audit findings, and articulate results to stakeholders
Accurately complete audit review forms to verify adherence to REMS program requirements
Formally record and report audit results, document corrective and preventive actions
Collaborate with REMS Auditors to share best practices
Complete SOP reviews and client-specific training within specified timelines consistently
Assisting in the development of project-specific documentation, including audit plans, procedures, and work instructions
Assisting in training REMS Associate Auditors in program audit techniques, ensuring thorough coverage of both project-specific and soft skills
Maintain professional communication across all organizational levels, with clients, sponsors, and regulatory authorities
Manage multiple tasks and priorities according to business needs
Assist in reviewing audit questionnaires and supporting documentation to meet client time constraints
Collaborate with REMS Auditors to promote sharing of best practices
Conduct on-site audits as requested by clients
May support the Global Quality Compliance team with client and regulatory audits
Qualification
Required
Minimum Associate Degree required
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
Preferred
Bachelor's Degree preferred or equivalent work experience
GxP And/or Healthcare Setting Experience Highly Preferred
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
Company
UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$0.04M2017-11-27Acquired
2010-08-13Series Unknown· $0.04M
Leadership Team
Bekki Brown
Chief Executive Officer
Nicole Hebbert
SVP, Head of Patient Support Services
Recent News
Venture Capital
2026-01-06
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