Associate REMS Compliance Auditor at United Biosource Corporation

, , United States -

Full Time

Start Date

Immediate

Expiry Date

21 Feb, 26

Salary

0.0

Posted On

23 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Attention To Detail, Analytical Skills, Pharmaceutical Industry Practices, REMS Guidelines, FDA Regulatory Requirements, Microsoft Office Suite, Organizational Skills, Time Management Skills, Willingness To Learn, Adaptability, Problem-Solving Abilities, Ethical Standards, Confidentiality Protocols, Professionalism Under Pressure

Industry

Biotechnology Research

Description

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! 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 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 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 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. #LI-JM1 #LI-REMOTE

Responsibilities

The Associate REMS Auditor provides core compliance functions and project support for the REMS Stakeholder audit group. This includes communication with stakeholders, review of audit documentation, and ensuring compliance with REMS program requirements.