Overview You're driven, resourceful, and above all else - remarkably smart. You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn't cut it - you've got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you're known for your good nature. You'll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door. Responsibilities The Engagement Center Compliance Specialist collaborates and supports the REMS Engagement Center to identify, investigate, address, and document/track 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. In this exciting opportunity, you are a great fit if you can....
- Support the Engagement Center REMS 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)
- Coordinates corrective actions with stakeholders and follows 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.
- 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.
- Assist Engagement Center colleagues with challenging times when peak volumes are achieved or personnel are absent which can be on nights/holidays/weekends.
- 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.
- Attendance at educational workshops and training sessions to ensure professional and technical knowledge
Job Requirements 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 take into consideration transferrable skills from previous roles. We also encourage you to to stay connected to additional career opportunities.
Along with a results-oriented mindset, self-assurance and an engaging manner, the ideal candidate has:
- BA/BS Degree required
- Experience with Risk Evaluation and Mitigation Strategy (REMS)
- One or more years of experience in the pharmaceutical or healthcare industry, with emphasis on compliance
Preferred
- Experience inbound and outbound call center programs.
Job Qualifications:
- Knowledge of call center operations and processes.
- 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.
- Proficient in Microsoft Word, Excel, PowerPoint, Outlook or similar electronic mail program.
- Proficient with investigation databases and case management systems and tools
Interviews may be conducted in person at an on-site interview location. For any in-person interviews, local COVID-19 safety guidelines will be followed. Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Here, each day brings an opportunity to take ownership of a new challenge. Teaming with some of the most talented clinicians in the industry, you'll improve patient outcomes and work in a dynamic environment to create better, smarter, faster ways to get biopharmaceutical therapies to patients. By joining Syneos Health, you'll be connected to our multitude of career paths and pipeline of employment opportunities. WORK HERE MATTERS EVERYWHERE | How will you accelerate improving patient outcomes? Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)] As a healthcare company we have an important responsibility to protect individual and public health. Except in those locations where state or local law impacts this vaccination requirement, this position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities unless an exemption can be confirmed based on a medical condition, sincerely-held religious belief, or other reasons recognized by applicable law. Submission and approval of an exemption request does not necessarily guarantee that an accommodation can be provided for any specific job.
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