Job description
TITLE:
Compliance Auditing & Monitoring Lead
Title: I&C Auditing & Monitoring Lead
Reports To: Head, I&C Analytics, Reporting, Auditing & Monitoring
Location: Richmond VA (Relocation assistance provided for non-local candidates)
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction – a chronic relapsing disease.
Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction – including opiate overdose, alcohol use disorders and cocaine intoxication - as well as related mental health disorders such as schizophrenia.
POSITION SUMMARY:
The Integrity & Compliance (I&C) Auditing & Monitoring Lead is part of the I&C Analytics, Reporting, Auditing & Monitoring Center of Excellence (COE) and will be responsible for enhancing and implementing Indivior’s Healthcare Compliance Auditing and Monitoring (A&M) program. In addition to traditional A&M techniques, the role leverages analytical mindset and technology to enhance the effectiveness and efficiency of Indivior’s Compliance Program. Lastly, the role is responsible for leading continuous improvement projects of systems, controls and processes and supervising A&M activities of interns and third party consultants.
PRINCIPAL RESPONSIBILITIES:
The responsibilities of this job include, but are not limited to, the following:
- Creating, administering, and regularly enhancing Indivior’s Healthcare Compliance A&M policies, procedures, audit programs, monitoring checklists, training materials. Implementing and managing I&C A&M system, solutions, or tools to enhance the effectiveness and efficiency of the A&M program.
- Supporting Indivior’s Annual Healthcare Compliance Risk Assessment & Mitigation Planning activities (RAMP) and developing risk-based and CIA-Required annual and multi-year Healthcare Compliance A&M plan.
- Executing systems/process audits and monitoring of promotional and non-promotional activities to evaluate compliance with Company policies and procedures and relevant regulations.
- Developing and enhancing A&M testing criteria, analyzing relevant information, identifying and documenting observations, related root causes and recommendations to mitigate risk and tracking the effectiveness of remediation plans implemented by relevant stakeholders.
- Identifying and implementing risk-based use-cases and continuous controls monitoring opportunities. This would entail leveraging technology, enhancing systems and working closely with I&C’s Analytic resources, cross-functional stakeholders and subject matter experts.
- Enhancing and maintaining A&M dashboards and reporting tools. Tracking A&M metrics, trends and observations, presenting meaningful, accurate and effective periodic reports to leadership including C-Suite.
- Collaborating with Indivior’s Internal Audit and Quality Audit functions. Providing support in preparation for all external inquiries and audits of systems or processes.
- Maintaining strong subject matter expertise to provide sound advice, coaching and guidance to stakeholders regarding compliance requirements, processes and risks.
- Developing and delivering relevant training to internal stakeholders and third-party consultants on A&M topics.
- Overseeing the A&M activities of interns and third-party consultants.
MINIMUM QUALIFICATIONS:
Education: Graduate Degree required
Experience:
- At least 7 – 10 years of compliance risk management and monitoring/auditing experience with a global or regional life sciences company, accounting firm or healthcare consulting firm with emphasis in life sciences is required.
- In addition, five (5) years of previous compliance experience or related experience, such as working in sales, marketing, or healthcare compliance role will be considered.
- Experience in Healthcare Compliance or Regulatory Affairs is preferred.
- Candidates with experience developing and/or implementing compliance program analytics strongly preferred.
Travel: 40-60% of time, as needed under direction of the Head, I&C Analytics, Reporting, Auditing & Monitoring
COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:
- Strong project management skills with the ability to drive execution by relevant stakeholders.
- Strong problem solving, critical thinking skills. Sound judgment, attention to detail, ability to maintain confidentiality, comfortable with ambiguity and can adapt style and tactics based on situation
- Strong interpersonal skills, with ability to forge strong relationships with all levels of the organization, and effective influencing skills with the ability to drive change as it relates to implementing remedial actions
- Ability to effectively prepare and present analytical written and oral communications appropriate for multiple audiences and levels within the organization
- Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including OIG and PhRMA guidelines, healthcare standard operating procedures, Sunshine provisions of the Affordable Care Act, Food, Drug & Cosmetics Act and supporting regulations, OPDP requirements and state price reporting statutes
BENEFITS:
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes
- 3 weeks’ vacation plus floating holidays and sick leave
- 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
- U.S. Employee Stock Purchase Plan- 15% Discount
- Comprehensive Medical, Dental, Vision, Life and Disability coverage
- Health and Dependent Care Flex Spending options
- Adoption assistance
- Tuition reimbursement
- Leverage Concierge/personal assistance services
- Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
- Gym, fitness facility and cell phone discounts
- Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.
GUIDING PRINCIPLES:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled
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