Description
You’re a meticulous, data-driven professional who thrives on accuracy, analyzes information with precision, and understands that in compliance, the details matter.
In this role as a Compliance Specialist, you will be responsible for identifying, investigating, addressing, and documenting/tracking any potential noncompliance with the REMS program requirements.
The Compliance Specialist will be responsible for data monitoring, interacting with and advising key internal and external stakeholders, verifying completion of noncompliance activities and ad-hoc reporting to support Syneos Health and the REMS Program requirements. The Compliance Specialist will also serve as point of contact for program specific Specialty Pharmacies (SPs) and/or Specialty Distributors (SDs) to coordinate training, expectations, and coordinating technology set up. Provide timely and accurate reconciliation of SP and/or SD dispensing/shipping information and support all activities that facilitate patient access.
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.
- Responsible for ensuring 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).
- Provide timely reports, both orally and in writing regarding the status of non-compliance events.
- Coordinates corrective actions with stakeholders and follows through to ensure they are implemented in a timely manner.
- Demonstrate knowledge of company and client standards, project specific compliance guidelines, product and disease state landscape.
- Provide training and education to contracted SPs and/or SDs about the program, processes, and data requirements.
- Provide consistent and effective communication to all appropriate stakeholders as first line support/single point of contact with contracted SPs and/or SDs.
- Review all incoming daily data from the contracted SPs and/or SDs, review exception errors generated from each contracted data feed, and outreach to contracted SPs and/or SDs related to outstanding restatements. Ensure all contractual timeframes related to SP and/or SD data review are successfully met, as applicable.
- Lead calls with each contracted SP and/or SD to review identified issues with shipment files and/or patient status files to include those patients at risk of lapsing in therapy, shipment and/or insurance delays, missing shipment, and updates.
- Provide timely tracking of receipt of referral, status of contracted SP activity, and potential interruptions in therapy.
- Engage in REMS program auditing and/or monitoring activities.
- Assist Engagement Center colleagues with challenging times when peak volumes are achieved or personnel are absent which can be on nights/holidays/weekends.
- Complete all necessary compliance training in the specified timeframe.
- Be able to problem solve and participate in the process of creating solutions as well as identify and escalate priority issues to management.
- Responsible for analyzing incoming data and recognizing trends and cases that need further action.
- Gather, analyze, and prepare data, for Quarterly Business Reviews (QBRs), Compliance Committee Meetings, FDA requirements, and other special projects and reports as applicable.
- Conduct incoming and outgoing calls in professional manner following client guidelines and business rules.
- Document all communication in the appropriate application contact log in an accurate, concise, and timely manner.
- Attendance at educational workshops and training sessions to ensure professional and technical knowledge.
- Preform other duties as assigned.
Job Qualifications:
Education
- Bachelor’s Degree preferred
- High School diploma required
Required Skills
- One or more years of experience in Risk Evaluation and Mitigation Strategy (REMS)
- 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
Preferred
- Experience inbound and outbound call center programs.
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)
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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