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 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 required; 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) OR 20 days PTO
- 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
