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Job Requirements of Risk Evaluation and Mitigation Strategy (REMS):
-
Employment Type:
Contractor
-
Location:
Raleigh, NC (Onsite)
Do you meet the requirements for this job?
Risk Evaluation and Mitigation Strategy (REMS)
Careers Integrated Resources Inc
Raleigh, NC (Onsite)
Contractor
Job Title: Risk Evaluation and Mitigation Strategy (REMS)
Location: Raleigh, NC (Hybrid)
Duration: 08 Months+
Job Description:
Compliance Assurance:
Audit Coordination:
Data Management:
Performance Monitoring:
Stakeholder Engagement:
Education: Bachelors
Experience:
Communication and Interpersonal Skills:
Regulatory & Technical Knowledge:
Innovation and Adaptation:
Location: Raleigh, NC (Hybrid)
Duration: 08 Months+
Job Description:
- Please note: This role is VDI only. No laptop or equipment will be provided, candidates need to use their own laptop.
- Location is preferred for Raleigh, but ATL is okay.
Compliance Assurance:
- Provide direct support to the REMS Lead auditor to ensure that all REMS audits are conducted in compliance with FDA REMS requirements, contractual arrangements, standard operating procedures, and safety and welfare of patients.
- This includes maintaining adequate records to demonstrate that REMS requirements have been met, such as records of distribution and dispensing, certification of prescribers and pharmacies, enrollment of patients, documentation of completed Patient Status Forms and Cardiovascular Event Reporting Forms, and audits of REMS participant records.
Audit Coordination:
- Coordinate audits across various REMS implementing entities, including REMS Coordinating Center, Outpatient Pharmacy, Inpatient Pharmacies, Wholesalers, and other distributors.
- This involves creating audit records in advance, uploading audit documents, and managing the review and approval workflow.
Data Management:
- Monitor and manage the REMS audits group email inbox, respond to requests, and notify the REMS Lead Auditor for support.
- Ensure proper data entry and tracking of audit reports and CAPAs in the Veeva audit system for REMS and other GxP audits run globally.
Performance Monitoring:
- Track and monitor the progress of REMS audits, ensuring timely completion and compliance with audit plans.
- This includes conducting daily internal audits for all dispenses a Productst the requirements of the REMS, performing quality checks, and maintaining records for FDA inspections.
Stakeholder Engagement:
- Engage with key stakeholders and service providers involved in the REMS program to ensure effective communication and collaboration.
- This includes managing notifications of new enrollments within the internal REMS audits tracker and archiving enrollment forms.
Education: Bachelors
Experience:
- 5 years of experience in the pharmaceutical industry within regulated areas (e.g., Research, Laboratory, Clinical, Pharmacovigilance, Manufacturing, ...) and/or Quality Assurance expertise.
- Knowledge and understanding of the complexity of the BioPharma business, including drug development process, REMS and post-marketing obligations, GXP principles and digital trends.
- Proven project management, process improvement and optimization experience, with specific Quality Assurance application.
- Previous experience as Auditor is a plus.
Communication and Interpersonal Skills:
- Effective written and verbal communication skills for facilitating dialogue across all levels of the organization.
- Effective at communicating and building relationships with team members, stakeholders, and other departments globally.
Regulatory & Technical Knowledge:
- Must be knowledgeable in the global pharmaceutical industry, including the interpretation and application of applicable U.S.
- REMS and GxP regulations in complex situations.
Innovation and Adaptation:
- Ability to innovate and adapt to changing business environments.
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