Description

You’re a proactive problem-solver who thrives in a fast-paced environment where accuracy, integrity, and compliance matter.

In this role as a Compliance Specialist, you will be responsible for responsible for identifying, investigating, addressing, and documenting/tracking any potential noncompliance with the REMS (Risk Evaluation Mitigation Strategies) program requirements.

You will:

• 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.

Job Qualifications:

Education

• Bachelor’s Degree required

Required Skills

• 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.
• Knowledge of call center operations and processes.
• Skill in telephone and/or customer service experience and etiquette.
• Efficient computer and data entry skills; ability to learn new systems and programs quickly.
• Ability to work with a team and maintain a positive attitude.
• Ability to communicate clearly and effectively written and verbal.
• Ability to multitask, prioritize day-to-day responsibilities and meet deadlines.
• Excellent analytical, problem-solving, and organizational skills required.
• Experience in high-pressure and fast paced environment
• Ability to maintain confidentiality involving compliance and company information and activities.
• Demonstrate current working knowledge of various rules, regulations, and industry guidance relevant to healthcare compliance.
• Must be able to effectively communicate with Engagement Center representatives, internal departments, clients and management.
• Proficient in Microsoft Word, Excel, PowerPoint, Outlook, or similar electronic mail program.
• Proficient with investigation databases and case management systems and tools.
  

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Why Syneos Health? Here, the work is challenging, and the pace is exhilarating. By joining one of our commercial teams, you’re empowered to succeed with the support, resources, and autonomy that you need. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Syneos Health has launched more sales teams in the last 5 years across all major therapeutic areas than the top 25 pharma companies combined. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients’ lives around the world. 

Work  Here  Matters  Everywhere  | How are you inspired to change lives?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.

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