Associate REMS Compliance Auditor

As a pharmaceutical support industry leader, UBCis devoted toempoweringhealth solutions for a better tomorrow. We takeprideinimprovingpatient outcomes andadvancinghealthcare.At UBCwe provide services to enhance the entire drug development process andcommercialization lifecycle - From clinical trial support to real-worldevidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningfulimpacton theworldaround you.UBCfosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in aninclusive workplacethat fosters creativity.

If you are seeking a career that willchallenge, inspire,andrewardyou, join us atUBC!

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 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

Identifies, evaluates, and addresses 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 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 require; 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:

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

Hereare some of the exciting perks UBC offers:

Remote opportunities

Competitive salaries

Growth opportunitiesfor promotion

401K with companymatch*

Tuitionreimbursement

Flexible workenvironment

Discretionary PTO(Paid Time Off)

Paid Holidays

Employee assistanceprograms

Medical, Dental, andvision coverage

HSA/FSA

Telemedicine(Virtual doctor appointments)

Wellness program

Adoption assistance

Short termdisability

Long term disability

Life insurance

Discountprograms

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

Originally posted on Himalayas