Company Description
At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!
Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.
Job Description
THE POSITION:
The Senior Regulatory Specialist manages regulatory compliance programs, with an emphasis on licensure, regulatory intelligence, controlled substance due diligence, and operational regulatory support within pharmaceutical distribution and 3PL environments.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
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Manage End-to-End Licensing Compliance
Lead the preparation, submission, renewal, and maintenance of all state and federal licenses, including coordination with third-party vendors and internal stakeholders, and validation of corporate officers, designated representatives, and supporting licensure requirements.
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Maintain Licensing Records & Inspection Readiness
Ensure accurate, audit-ready documentation of all facility licenses and supporting materials, including timely availability for regulatory inspections, client requests, and internal reviews.
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Lead Regulatory Intelligence & Impact Assessment
Monitor and interpret regulatory updates from BOP, DOH, FDA, DEA, and industry organizations (e.g., NABP, ASHP, APHA), and assess applicability to operations and compliance programs.
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Drive Regulatory Implementation & Governance
Maintain regulatory intelligence reporting processes and support the integration of regulatory changes into SOPs, operational controls, and business processes.
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Provide Operational Regulatory Support
Support distribution and client operations by addressing regulatory inquiries, including customer licensure verification, shipment compliance requirements, and alignment with applicable regulations.
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Execute Controlled Substance Due Diligence & Monitoring
Conduct risk-based due diligence on customers handling controlled substances, including onboarding and periodic reviews, evaluating licensure, regulatory standing, and business activity, and investigating and escalating suspicious or abnormal orders through monitoring systems.
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Support Controlled Substance Compliance Program Effectiveness
Collaborate cross-functionally to determine appropriate disposition of controlled substance orders, maintain documentation of due diligence decisions, and support continuous improvement of suspicious order monitoring and customer due diligence procedures to ensure alignment with DEA and state requirements.
Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by an employee with a disability, unless such accommodation would cause an undue hardship for EVERSANA. If reasonable accommodation is needed to perform the essential functions of your job position, please contact Human Resources.
EXPECTATIONS OF THE JOB:
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Travel: Occasional travel may be required, less than 20%
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Hours: 40 Hours per week
The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.
An individual in this position must be able to successfully perform the expectations listed above.
Qualifications
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.
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Education: Bachelor’s degree or 1-3 years’ experience equivalent.
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Experience and/or Training:
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Strong problem-solving, risk assessment, and impact analysis abilities.
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Flexible and able to multitask and prioritize competing demands/workflow.
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Excellent oral and written communication skills.
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Licenses/Certificates (e.g. trade certificates, driver’s licenses, professional certifications, etc. required)
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Technology/Equipment (if applicable, the proficiencies required to perform the job)
PREFERRED QUALIFICATIONS:
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Education: Bachelor’s degree with a life sciences discipline.
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Experience and/or Training:
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1-3 years in a pharmaceutical environment.
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Strong problem-solving, risk assessment, and impact analysis abilities.
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Flexible and able to multitask and prioritize competing demands/workflow.
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Excellent oral and written communication skills
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Licenses/Certificates: FL or CA Designated Representative
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Technology/Equipment:
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Strong MS Office skills (Outlook, Word, Excel, PowerPoint)
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Basic knowledge of Suspicious Order Monitoring systems.
PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT:
The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.
Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands.
Additional Information
OUR CULTURAL BELIEFS:
Patient Minded I act with the patient’s best interest in mind.
Client Delight I own every client experience and its impact on results.
Take Action I am empowered and empower others to act now.
Grow Talent I own my development and invest in the development of others.
Win Together I passionately connect with anyone, anywhere, anytime to achieve results.
Communication Matters I speak up to create transparent, thoughtful and timely dialogue.
Embrace Diversity I create an environment of awareness and respect.
Always Innovate I am bold and creative in everything I do.
Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.
EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). This role is eligible for hire in select U.S. locations based on business and operational considerations. For a full list of locations, visit eversana.com/careers. More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time.
From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.
Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at [email protected].
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