REMS Compliance Auditor

United Biosource Corporation

2d•Remote

About The Position

As a pharmaceutical support industry leader, 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. Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity. If you are seeking a career that will challenge, inspire, and reward you, join us at UBC! GxP and/or healthcare setting experience highly preferred. Job Title: YRC04G – REMS Auditor Brief Description: The Risk Evaluation and Mitigation Strategy [REMS] Auditor provides core compliance functions and project support for the REMS Stakeholder audit group. The REMS Auditor acts as a liaison with stakeholders such as healthcare settings, pharmacies, and wholesalers/distributors. This involves reviewing audit questionnaires, examining supporting documentation, and documenting all related information within project-specific applications. Through these efforts, the REMS Auditor ensures the smooth execution of audits while maintaining compliance standards and fostering effective communication with stakeholders. When necessary, this role involves supporting training for new hires, facilitating communication between the audit team and other internal and external teams and entities.

Requirements

Minimum Associate Degree require; Bachelor’s Degree preferred or equivalent work experience.
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.

Nice To Haves

GxP and/or healthcare setting experience highly preferred.

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.