Pharmaceutical Compliance Specialist

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Assist in the REMS Call Center initiative to ensure compliance with FDA-mandated objectives and requirements.

• Perform investigations into possible non-compliance within REMS programs.

• Oversee prompt, comprehensive, confidential, and impartial investigations aligned with Syneos Health and REMS Program standards.

• Fulfill program compliance responsibilities, which encompass stakeholder re-education, documentation of non-compliant incidents, review of alerts/reminders, and follow-up with healthcare providers/pharmacies.

• Collaborate with stakeholders to coordinate corrective actions and ensure their timely execution.

• Provide training and education to contracted service providers (SPs) and/or stakeholders (SDs) regarding the program, processes, and data requirements.

• Participate in auditing and/or monitoring activities related to the REMS program.

⛳️ Requirements

• A Bachelor’s Degree is mandatory.

• Familiarity with Risk Evaluation and Mitigation Strategy (REMS) is essential.

• Understanding of call center operations and procedures is required.

• At least one year of experience in the pharmaceutical or healthcare sector, focusing on compliance.

• Proficient in telephone etiquette and customer service skills.

• Strong computer and data entry capabilities; must be able to quickly adapt to new systems and programs.

• Ability to collaborate with a team while maintaining a positive demeanor.

• Excellent written and verbal communication skills are necessary.

• Capability to manage multiple tasks, prioritize daily responsibilities, and adhere to deadlines.

• Strong analytical, problem-solving, and organizational abilities are required.

• Experience working in a fast-paced, high-pressure environment.

• Ability to maintain confidentiality regarding compliance and company activities.

• Up-to-date knowledge of rules, regulations, and industry guidance pertinent to healthcare compliance.

• Effective communication skills with Engagement Center representatives, internal departments, clients, and management are essential.

• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, or similar email applications.

• Familiarity with investigation databases and case management systems and tools is important.

🏝️ Benefits

• Health benefits encompassing Medical, Dental, and Vision coverage.

• 401k with company matching.

• Flexible paid time off (PTO) policy.

• Sick leave provisions.

• Competitive compensation package.

• Access to support, resources, and autonomy.

• Opportunities for training and education.

• A diverse, inclusive, and authentic workplace environment.

• Voluntary COVID-19 vaccination policy.