Virtual Pharmaceutical Compliance Specialist

Syneos Health; Charlotte (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

Syneos Health Commercial Solutions is seeking a Virtual Pharmaceutical Compliance Specialist in Charlotte, NC. You will identify and address noncompliance within REMS programs, conduct investigations, and document findings while coordinating corrective actions with stakeholders.

The role requires a Bachelor’s degree and experience with REMS and call center operations. You will train contracted personnel and participate in REMS auditing in a fast-paced environment.

Qualifications

• Bachelor’s degree required.
• Experience with REMS and healthcare compliance.
• Knowledge of call center operations and processes.
• Strong written and verbal communication skills.
• Proficient with MS Word/Excel/PowerPoint/Outlook.
• Experience with investigation databases and case management tools.

Responsibilities

• Support REMS Call Center to meet FDA-mandated requirements.
• Conduct investigations of potential REMS non-compliance.
• Manage confidential investigations per program requirements.
• Document non-compliant events and follow-up actions.
• Coordinate corrective actions with stakeholders and ensure timely implementation.
• Provide training on REMS processes and data requirements.
• Engage in REMS program auditing and monitoring.

Skills

REMS knowledge

Call center operations

Pharma/compliance experience

Written and verbal communication

Data entry/computer skills

Team player mindset

Analytical/problem solving

Confidentiality

Multitasking/ prioritization

Education

Bachelor’s Degree

Tools

Word

Excel

PowerPoint

Outlook

Investigation databases

Case management systems

Job description

Virtual Pharmaceutical Compliance Specialist

Updated: Yesterday
Location: Charlotte, NC, United States
Job ID:18875-OTHLOC-Ch5wYfwA

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.

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.

W o r k H e r e M a t t e r s E v e r y w h e r e | 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.

Discover what our more than 25,000 employees already know: work here matterseverywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday workimprovespatients’ lives around the world. Selecting us as an employer secures acareer inwhich you’re guaranteed to:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization builtto accelerate customer success. We translate unique clinical, medical affairs and commercialinsights into outcomes to address modern market realities. To learn more visit syneoshealth.com .

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: [emailprotected] One of our staff members will work with you to provide alternate means to submit your application.