[Hiring] Senior REMS Compliance Auditor @UBC

Role Description

UBC is seeking an experienced Senior REMS Compliance Auditor with management experience to oversee REMS Auditors.

The Risk Evaluation and Mitigation Strategy (REMS) Senior Auditor provides core compliance functions and project support for the REMS Stakeholder audit group. This role involves various responsibilities, including:

• Training new hires
• Facilitating communication between the audit team and clients
• Assisting in the completion of audits
• Acting as a liaison with stakeholders such as healthcare settings, pharmacies, and wholesalers/distributors
• Reviewing audit questionnaires and examining supporting documentation
• Documenting all pertinent information within project-specific applications

Through these efforts, the REMS Senior Auditor ensures the smooth execution of audits while maintaining compliance standards and fostering effective communication with stakeholders.

Specific job duties include:

• Consistently providing effective communication to all relevant stakeholders as the primary point of contact for REMS stakeholders
• Maintaining thorough and accurate documentation of all interactions
• Reviewing project-specific documentation, including audit plans, procedures, and work instructions
• Completing timely reviews of assigned audit questionnaires as per project deadlines
• Conducting document reviews to ensure completeness, accuracy, and compliance with REMS program standards
• Ensuring timely follow-up on audit documentation deficiencies and actions as per client timelines
• Identifying, evaluating, and addressing any audit findings, and articulating results to stakeholders
• Accurately completing audit review forms to verify adherence to REMS program requirements
• Assisting in continuous quality improvement efforts with REMS Auditors
• Formally recording and reporting audit results, documenting corrective and preventive actions
• Collaborating with REMS Auditors to share best practices
• Completing SOP reviews and client-specific training within specified timelines
• Developing project-specific documentation such as audit plans, procedures, and work instructions
• Providing program audit training to REMS Associate Auditors
• Maintaining professional communication across all organizational levels, with clients, sponsors, and regulatory authorities
• Managing multiple tasks and priorities according to business needs
• Assisting in reviewing audit questionnaires and supporting documentation to meet client time constraints
• Guiding audit teams in addressing audit findings and contributing to continuous quality improvement initiatives
• Conducting on-site audits as requested by clients
• May support the Global Quality Compliance team with client and regulatory audits

Qualifications

• 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
• 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

Requirements

• Supervisory Responsibility: Up to five (5) direct reports
• Traveling: 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