Remote REMS Compliance Specialist

Syneos Health; Raleigh (NC); In loco; USD 65.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits (Medical, Dental, Vis

Company 401k match

PTO and sick time

Vaccination policy

Descrizione del lavoro

Syneos Health in Raleigh, NC, is seeking a Virtual Pharmaceutical Compliance Specialist to identify and address noncompliance within REMS programs. You will document investigations and coordinate corrective actions across stakeholders.

The role requires a Bachelor’s degree with experience in REMS and pharmaceutical compliance, plus strong communication and data-entry skills for fast-paced environments.

Competenze

• Bachelor’s degree required.
• Experience with REMS.
• Knowledge of call center operations.
• 1+ year in pharmaceutical or healthcare compliance.
• Proficient in MS Word, Excel, PowerPoint, Outlook.
• Ability to maintain confidentiality.

Mansioni

• Support the REMS Call Center program to help ensure FDA mandated requirements/goals are met.
• Conduct investigations of potential non-compliance within REMS programs.
• Manage and ensure prompt, thorough, confidential, and objective investigations in accordance with Syneos Health and the REMS Program requirements.
• Ensure all program compliance duties (including re-education of stakeholders, documentation of non-compliant event, review of alerts/reminders, and healthcare provider/pharmacy follow-up) are completed for the assigned REMS program(s).
• Coordinate corrective actions with stakeholders and follow through to ensure they are implemented in a timely manner.
• Provide training and education to contracted SPs and/or SDs about the program, processes, and data requirements.
• Engage in REMS program auditing and/or monitoring activities.

Conoscenze

REMS

Call center ops

Pharma/Healthcare

Compliance

Communication

Data entry

Teamwork

Confidentiality

MS Office

Investigation tools

Formazione

Bachelor’s Degree

Descrizione del lavoro

Syneos Health in Raleigh, NC, is seeking a Virtual Pharmaceutical Compliance Specialist to identify and address noncompliance within REMS programs. You will document investigations and coordinate corrective actions across stakeholders.

The role requires a Bachelor’s degree with experience in REMS and pharmaceutical compliance, plus strong communication and data-entry skills for fast-paced environments.