Associate REMS Compliance Auditor

United Biosource Corporation; États-Unis; À distance; USD 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Remote opportunities

401K with company match

Paid Time Off

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Discount programs

Résumé du poste

United Biosource Corporation (UBC) is seeking an Associate REMS Compliance Auditor to support the REMS stakeholder audit group. The role focuses on ensuring audit documentation, communication with stakeholders, and adherence to REMS program requirements while working in a remote, home-based setting in the USA.

You will review audit plans, questionnaires, and supporting materials; maintain records; and collaborate with REMS teams to drive timely, compliant outcomes, with a focus on accuracy,

Qualifications

• Associate degree required; bachelor’s degree preferred.
• Strong attention to detail and analytical skills.
• Basic understanding of pharmaceutical industry practices, REMS guidelines, and FDA 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.
• Strong problem-solving abilities and confidentiality commitment.

Responsabilités

• Provide clear communication to REMS stakeholders as first line contact with REMS stakeholders.
• Maintain accurate documentation of all contacts.
• Review project documentation that may include audit plans and procedures.
• Complete review of all audit questionnaires within the time constraints listed in the audit plan.
• Conduct document review of submitted documentation for completeness and REMS program compliance.
• Ensure follow-up of 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 to ensure documentation meets REMS requirements.
• Assist in development of continuous quality improvement with REMS Senior Auditors.
• Ensure audit results are recorded and corrective/preventive actions documented.
• Collaborate with REMS team to share best practices.
• Complete SOP reviews and client training within timelines.

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Associate REMS Compliance Auditor

All Virtual Locations, Home Based Position, USA, Remote, US

As a pharmaceutical support industry leader , UBC is devoted to empoweringhealth solutions for a better tomorrow . We take pride in improving patient outcomes and advancinghealthcare. At UBC we provide services to enhance the entire drug development process andcommercialization lifecycle - From clinical trial support to real-worldevidence generation.

Embark on a rewardingcareer journey with UBC! Growyour 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!

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

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
• Growth opportunitiesfor promotion
• 401K with companymatch*
• Discretionary PTO(Paid Time Off)
• Paid Holidays
• Employee assistanceprograms
• Medical, Dental, andvision coverage
• HSA/FSA
• 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.