SVP, Compliance, Quality and Ethics

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 SVP of Compliance, Quality and Ethics will report to the Chief Compliance Officer to ensure full compliance with all applicable regulations and privacy laws globally and all corporate compliance initiatives as assigned by headquarters.

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

Build & Improve the Company's Regulatory Compliance Program

• Develop, implement, and maintain compliance systems and procedures for all service lines
• Develop, implement and maintain internal training procedures with respect to those compliance systems and procedures
• Present to Board of Directors and Executive Leaders quarterly on state of compliance
• Provide ongoing and regular counsel in support of outsourcing activities, including marketing and sales efforts, HCP interactions, patient advocacy group interactions, and other relevant activities and initiatives
• Provide necessary legal support for the Sunshine Act, False Claims Act, Kickback Statue, OIG guidance, PhRMA code, and state-by-state pharmacy laws
• Provide support and serve as the principal point of contact for interactions with regulatory bodies including but not exclusive to State Boards of Pharmacy, FDA, HHS, DOJ, and DOL
• Review of outward facing communications with regulatory implications
• Keep informed of new laws, regulations and industry trends affecting the company, and assist with development of policies and training as needed.
• Secure and maintain the buy-in and support of leadership and management at all levels of the company in respect of the compliance standards required by the groups and its shareholders.
• Develop the existing compliance environment to balance the risk of violation with the administrative burden on the operational organization.
• Ensure compliance training and education is available to, and completed by the employees of the company including, but not limited to, delivering training sessions, self-service information resources and Computer Based Training.
• Manage all compliance inquiries and potential violations reported through the established helpline and whistle-blower services.
• Manage all Governance issues of the Compliance environment globally.
• Maintain and revise policies and procedures for the general operation of the Compliance Program and its related activities to prevent illegal, unethical, or improper conduct. Manages day-to-day operation of the Program.
• Develop and periodically review and update The Code of Conduct to ensure continuing currency and relevance in providing guidance to management and employees.
• Collaborates with other departments (e.g., Quality, Internal Audit, Human Resources, Legal, etc.) to direct compliance issues to appropriate existing channels for investigation and resolution. Consults with the legal department as needed to resolve difficult legal compliance issues.
• Respond to alleged violations of rules, regulations, policies, procedures, and Code of Conduct by evaluating or recommending the initiation of investigative procedures. Develops and oversees a system for uniform handling of such violations.
• Identify potential areas of compliance vulnerability and risk and conduct annual risk assessments
• Provide reports on a regular basis, and as directed or requested, to keep senior management informed of the operation and progress of compliance efforts.
• Ensure proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate and/or required.
• Establish and provide direction and management of the compliance Hotline.
• Institute and maintain an effective compliance communication program for the organization, including promoting (a) use of the Compliance Hotline; (b) heightened awareness of the Code of Conduct, and (c) understanding of new and existing compliance issues and related policies and procedures.

Intra-organizational Collaboration

• Work with business teams and senior management to ensure awareness of "best practices" on privacy and data security issues
• Collaborate on cyber privacy and security policies and procedures
• Interface with Senior Management to develop strategic plans for the collection, use and sharing of information in a manner that maximizes its value while complying with applicable privacy regulations
• Assist business units with development of tools and methodologies to ensure ongoing compliance
• Provide strategic guidance to corporate officers regarding information resources and technology
• Assist the Chief Information Officer with the development and implementation of an information infrastructure
• Act as a liaison to the information technology department
• Collaborate with the legal department on privacy issues relating to business partner contracts and product-related activities
• Develop a process for receiving, documenting, tracking, investigating and taking action on all privacy related complaints

Incident Response

• Develop, implement and train on the Company's Incident Response Plan
• Mitigate effects of a use or disclosure of personal information by employees or business partners by ensuring the implementation of an incident response plan
• Administer action on all complaints concerning the organization's privacy policies and procedures in coordination and collaboration with the Compliance Investigation Team and, when necessary, legal counsel
• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
• All other duties as assigned.

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:

• Travel (5-10%, as needed)
• 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.

• 20+ years Compliance experience
• J.D. from accredited law school accepted but NOT required
• Comprehensive knowledge and understanding of the relevant legal, regulatory and compliance issues and their practical application
• Health law expertise (FDA regulations and guidance’s; federal and state kickback laws; the prohibition against off-label promotion; FCPA; False Claims Act) to advise the company
• Knowledge of the managed markets/payer industry, such as PBMs, rebate agreements, specialty pharmacies and related payer groups, as well as Medicare.
• Knowledge of US and EU privacy laws related to the pharmaceutical and clinical research industry
• Experience with building and implementing a privacy program
• Extensive experience and skill at writing policies and guidance documents supporting various business activities and conducting investigations.
• Ability to write clearly and prepare professional communications
• Experience working with teams across full corporate structure
• Excellent interpersonal and conflict resolution skills and ability to work in a highly collaborative, team-oriented environment
• High level of influencing skills and ability to drive change as it relates to implementing remedial actions
• Prior in-house experience preferred

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.

EVERSANA is committed to providing competitive salaries and benefits for all employees. The anticipated base salary range for this position is $250,000.00 to $275,000.00 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). 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.

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 applicantsupport@eversana.com.

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