Remote REMS Compliance Specialist

Syneos Health, Inc.

Raleigh (NC)

On-site

USD 65,000 - 95,000

Full time

7 days ago

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Benefits offered by this job

Health benefits

401k match

Flexible PTO

Job summary

Syneos Health, Inc. is seeking a Virtual Pharmaceutical Compliance Specialist in Raleigh, NC. This role focuses on identifying, investigating, and documenting REMS noncompliance, supporting the REMS Call Center to meet FDA requirements, and coordinating corrective actions with stakeholders.

The candidate will train contracted staff and participate in auditing activities. The position requires a Bachelor’s degree and at least one year in pharma/healthcare compliance, with strong communication,

Qualifications

Bachelor’s Degree required
Experience with Risk Evaluation and Mitigation Strategy (REMS).
Knowledge of call center operations and processes.
One or more years of experience in the pharmaceutical or healthcare industry, with emphasis on compliance.
Proficient in Microsoft Word, Excel, PowerPoint, Outlook, or similar electronic mail program.

Responsibilities

Identify, investigate, address, and document potential noncompliance with REMS program requirements.
Support REMS Call Center to ensure FDA-mandated requirements/goals are met.
Conduct investigations of potential non-compliance within REMS programs.
Coordinate corrective actions with stakeholders and follow through to ensure implementation.
Provide training and education to contracted SPs/SDs about the program and data requirements.
Engage in REMS program auditing and monitoring activities.