REMS Compliance Specialist — Investigations & Training

Syneos Health/ inVentiv Health Commercial LLC; Charlotte (NC); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

Syneos Health/ inVentiv Health Commercial LLC is seeking a Compliance Specialist to identify and address noncompliance within REMS programs. You will document investigations, support the REMS Call Center, and coordinate corrective actions with stakeholders in a fast-paced, regulated environment.

The role requires a Bachelor's degree and experience with REMS, strong communication, and the ability to handle confidential information while meeting deadlines.

Qualifikationen

• Bachelor's degree required.
• Experience with REMS.
• Knowledge of call center operations.
• One+ year in pharma/healthcare compliance.
• Clear written and verbal communication.
• Ability to learn new systems quickly.
• Strong analytical and organizational skills.
• Experience in high-pressure environments.
• Maintain confidentiality of compliance information.
• Proficient in MS Office tools.

Aufgaben

• Support the REMS Call Center program to meet FDA-mandated requirements.
• Investigate potential noncompliance within REMS programs.
• Manage confidential investigations per program requirements.
• Ensure all compliance duties are completed (education, documentation, follow-up).
• Coordinate corrective actions with stakeholders and ensure timely implementation.
• Provide training to contracted SPs/SDs on the program and data requirements.
• Engage in REMS program auditing and monitoring activities.

Kenntnisse

REMS knowledge

Call center operations

Pharma/healthcare compliance

Written and verbal communication

Multitasking

Data entry

Confidentiality

Analytical thinking

Team collaboration

Ausbildung

Bachelor's degree

Tools

Investigation databases

Case management systems

MS Office (Word/Excel/PowerPoint/Outlook)

Jobbeschreibung

Syneos Health/ inVentiv Health Commercial LLC is seeking a Compliance Specialist to identify and address noncompliance within REMS programs. You will document investigations, support the REMS Call Center, and coordinate corrective actions with stakeholders in a fast-paced, regulated environment.

The role requires a Bachelor's degree and experience with REMS, strong communication, and the ability to handle confidential information while meeting deadlines.