Executive Director Compliance & Regulatory

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.  

The Executive Director Compliance and Regulatory is responsible leading the quality and compliance efforts for multiple client projects and ensuring all local and federal regulations are followed.  This position will be responsible for contributing to and managing a team of Eversana internal employees and external vendor in the design, development, and delivery of complex projects covering a variety of subject matter areas.

Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by:

• Strong understanding of healthcare compliance and enforcement environment
• False Claims Act, Anti-kickback Statute, anti-bribery considerations, and CDE rules and regulations
  • Food Drug and Cosmetic Act U.S.C. Title 21, Chapter 9
  • Affordable Care Act
  • False Claim Act 31 U.S.C. 3729-33
  • Anti-Kickback Statute Social Security Act SEC. 1128B. [42 U.S.C. 1320a-7b]
  • PhRMA Code
  • Prescription Drug Marketing Act
  • HHS-OIG Guidelines
  • HIPAA
  • Other State Laws
  • General Data Protection Regulations (GDRP)
• Commercial compliance consulting: risk assessments, policies and SOPs, training materials
• Transparency reporting and aggregate spend: process assessments, policies and SOPs, business process outsourcing and managed services
• Knowledge of commercial compliance and ability to conduct training as it relates to the   Life Sciences industries and how they effectively and compliantly interact with HCPs/HCOs and operate in the marketplace
• Supporting development of proposals
• Auditing and Monitoring: plan development, live monitoring, transactional reviews, data analytics and outsourced managed monitoring services
• Working knowledge of global (EU) data laws at the country specific level
• Data Management and Data Protection:  must be the lead advocate in managing the compliance and operations oversight to handling  Third Party or Client Data following the Security and Privacy policies within Deployment Solutions. [lets discuss…confirm ie: PI?]
• Program and process design: compliance programs, HCP engagements, FMV, grants and contributions management (Honorarium, Sunshine Act)[these are diff activity…sunshine act not app; honorarium is a process]
  • Sales activities (expense report sign in sheets etc):  Accuracy of Data and Records and QA auditing Sales Force
    • Drug Samples distributed to prescribers (FDA)
    • Any transfers of value provided to U.S. licensed physicians and teaching hospitals, including Clinical Research Spend (CMS’ Open Payments Program)
    • Specific State regs on Aggregate Spend reporting
    • Vendor Credentialing
• Internal projects and initiatives as needed specific for Deployment Solutions
• Oversight of the creation of content of templates and training materials to streamline and optimize new project start-up and team-member onboarding
• Managing and collaborating with project teams in the design, development, and delivery of client deliverables
• Providing guidance on oversight, tracking, and monitoring of project status and delivery specific to Deployment Solutions Compliance activities
• Providing high level input to, and ensures the development of, client reports and presentations and delivery of all or significant portions of findings to client[can we discuss]
• Leveraging Life Sciences experience and business acumen to recommend improvements and alternative solutions to resolve client challenges.. Partner with Deployment Solutions to ensure client deligh.
• Sharing subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients[discuss..advisory level not SME?]
  • Adverse Events and Product Complaints fully understood and the advocate for Deployment Solutions
  • On the Road or Virtual Field auditing the Sales Reps
  • Internal Auditing and Monitoring program and  internal review of Business activity related to COC and the Compliance Program. Random and For Cause elements.

• Established and manage Corrective Actions and Disciplinary actions program from inception to completion
• In addition to the client-focused activities, you are expected to contribute to the continued growth of the practice including:
• Working closely with Corporate Quality & Compliance and other BU leadership to align with Policy, Practices, and Compliance Escalations and provide “Quality at the Source” oversight to ensure Compliance to Regs and Laws. 

Institute a Quality Management System and Compliance program within Deployment Solutions Operations, including 1- Developing robust SOPs, Work Instructions and Job Aids, so all Job Roles are accountable for their responsibilities within each area of Deployment Services Operations 2- Compliance oversight to Training to operations Policy and Procedures 3- Operations support of Client and Internal Audits  4-Operational support to Non Conformance and CAPAs 5-Operational Continuous Improvements determined by MBR and QBR

• All other duties as assigned.

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

• Education: Bachelor's Degree (life sciences, compliance law, public policy, pharmaceutical marketing, business, education, finance/accounting or related discipline preferred).
• Strong understanding of healthcare compliance and enforcement environment Development and oversight of compliance policies and procedures including adaptation of policies and procedures from a global to local perspective
• Substantial knowledge and understanding of industry including, but not limited to, OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, Anti-Kickback Statute, Sunshine Act, FCPA, UK Bribery False Claims Act, FDA rules and regulations and other industry guidance, and other issues affecting the development, sales, promotion and marketing of pharmaceutical and biological products.
• A minimum of 15 years’ of direct compliance experience in a compliance department of a healthcare company (Diagnostics, Medical Device, Pharma/Biotech)
• At least 5 years’ experience leading/transforming a strong compliance team and successfully managing and developing people
• Knowledge of federal and state laws and industry requirements affecting the biotech/pharma/device laws
• Specific prior experience in the development/deployment of a company-wide compliance program, including all of its elements: policy framework, Compliance operations, risk-control matrices and dashboards, training & awareness, auditing and monitoring, investigations, communications and Compliance culture/leadership
• Sophisticated ability to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations
• Experience in successfully innovating compliance, embedding compliance as a key business differentiator and competitive advantage in all aspects of the business

Preferred Skills:

• Education: Graduate-level Degree preferred (JD, MBA, or related discipline).
• Licenses/Certificates : Certification in Healthcare Compliance (CHC) preferred
• Technology/Equipment: Expert knowledge of Microsoft Suite, strong analytical and communication skills

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 hold myself accountable.  
• Embrace Diversity I create an environment of awareness and respect.  
• 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. 
• Always Innovate I am bold and creative in everything I do 

EVERSANA is committed to providing competitive salaries and benefits for all employees. The anticipated base salary range for this position is $177,000-$239,000 and is not applicable to locations outside of the U.S.  The base salary range represents the low and high end of the salary range for this position.  Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living).  EVERSANA reserves the right to modify this base salary range at any time.

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.

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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