REMS Compliance Specialist — Pharma

Syneos Health; Charlotte (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

Syneos Health Commercial Solutions is seeking a Virtual Pharmaceutical Compliance Specialist in Charlotte, NC. You will identify and address noncompliance within REMS programs, conduct investigations, and document findings while coordinating corrective actions with stakeholders.

The role requires a Bachelor’s degree and experience with REMS and call center operations. You will train contracted personnel and participate in REMS auditing in a fast-paced environment.

Qualifications

• Bachelor’s degree required.
• Experience with REMS and healthcare compliance.
• Knowledge of call center operations and processes.
• Strong written and verbal communication skills.
• Proficient with MS Word/Excel/PowerPoint/Outlook.
• Experience with investigation databases and case management tools.

Responsibilities

• Support REMS Call Center to meet FDA-mandated requirements.
• Conduct investigations of potential REMS non-compliance.
• Manage confidential investigations per program requirements.
• Document non-compliant events and follow-up actions.
• Coordinate corrective actions with stakeholders and ensure timely implementation.
• Provide training on REMS processes and data requirements.
• Engage in REMS program auditing and monitoring.

Skills

REMS knowledge

Call center operations

Pharma/compliance experience

Written and verbal communication

Data entry/computer skills

Team player mindset

Analytical/problem solving

Confidentiality

Multitasking/ prioritization

Education

Bachelor’s Degree

Tools

Word

Excel

PowerPoint

Outlook

Investigation databases

Case management systems

Job description

Syneos Health Commercial Solutions is seeking a Virtual Pharmaceutical Compliance Specialist in Charlotte, NC. You will identify and address noncompliance within REMS programs, conduct investigations, and document findings while coordinating corrective actions with stakeholders.

The role requires a Bachelor’s degree and experience with REMS and call center operations. You will train contracted personnel and participate in REMS auditing in a fast-paced environment.