[Hiring] Associate REMS Compliance Auditor @a158e395-baec-4e08-8f75-7d0702e34f73

Role Description

The Risk Evaluation and Mitigation Strategy (REMS) Associate Auditor provides core compliance functions and project support for the REMS Stakeholder audit group. Audit support includes, but is not limited to:

• Provide consistent and effective communication to all appropriate stakeholders as first line support/single point of contact with REMS stakeholders (healthcare settings, pharmacies, wholesalers/distributors).
• Maintain accurate and complete documentation of all contacts.
• Review project specific documentation that may include audit plans, project specific procedures, work instructions.
• Complete review of all audit questionnaires assigned within the time constraints listed in the audit plan for a specific project.
• Conduct document review of submitted documentation for completeness, accuracy, and REMS program compliance.
• Ensure follow-up of stakeholder audit documentation deficiencies and actions per client timelines.
• Communicate with stakeholders via phone or email for documentation still outstanding.
• Identify, evaluate, and address any audit findings.
• Articulate and explain audit results to stakeholders.
• Accurately complete the audit review form, either automated or manual, to ensure that documentation has been provided that meets the REMS program requirements.
• Assist in development of continuous quality improvement with REMS Senior Auditors.
• Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented.
• Work collaboratively with other REMS Associate Auditors, REMS Auditors, and REMS Senior Auditors to ensure that best practices are shared.
• Consistently complete SOP review and documentation within requested timelines.
• Consistently complete client specific training and documentation within requested timelines.

Qualifications

• 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.

Company Description

UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - from clinical trial support to real-world evidence generation. UBC fosters a culture built on our Core Values: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.