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 of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. 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!

Job title: YRC02F - Associate REMS Auditor

Brief 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, communication with stakeholders [healthcare settings, pharmacies, wholesalers/distributors], review of audit questionnaires and audit supporting documentation and appropriate documentation within the project-specific application.

  

Specific job duties:

Provide consistent and effective communication to all appropriate stakeholders as first line support/single point of contact with REMS stakeholders [healthcare settings, pharmacies, wholesalers/distributers]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 complianceEnsure follow-up of stakeholder audit documentation deficiencies and actions per client timelines.Communicate with stakeholders via phone or email for documentation still outstandingIdentifies, evaluates, and addresses any audit findingsArticulate and explain audit results to stakeholdersAccurately 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 AuditorsEnsure that audit results are formally recorded and reported and that corrective/preventative actions are documentedWork collaboratively with other REMS Associate Auditors, REMS Auditors and REMS Senior Auditors to ensure that best practices are sharedConsistently completes SOP review and documentation within requested timelines.Consistently completes client specific training and documentation within requested timelines.

  

Supervisory Responsibility: No supervisory responsibility.

 

Desired Skills and Qualifications:

Minimum Associate Degree required; Bachelor’s Degree preferred or equivalent work experienceStrong attention to detail and analytical skillsBasic understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies [REMS] guidelines and FDA regulatory requirementsProficiency in Microsoft Office suiteStrong organizational and time management skillsWillingness to learn and adapt to new processes and regulationsAbility to work efficiently and prioritize tasks effectively.Strong problem-solving abilitiesAdherence to ethical standards and confidentiality protocolsAbility to maintain composure and professionalism under pressure

Benefits:

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Here are some of the exciting perks UBC offers:

Remote opportunitiesCompetitive salariesGrowth opportunities for promotion401K with company match*Tuition reimbursementFlexible work environmentDiscretionary PTO (Paid Time Off) OR 20 days PTOPaid HolidaysEmployee assistance programs Medical, Dental, and vision coverageHSA/FSATelemedicine (Virtual doctor appointments)Wellness programAdoption assistanceShort term disabilityLong term disabilityLife insuranceDiscount programs

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.

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