U.S. Integrity & Compliance Officer

TITLE:

Title: U.S. Integrity & Compliance Officer

Reports to: Deputy Compliance Officer

Location: Richmond, VA

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. 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 and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category.

POSITION SUMMARY:

The U.S. Integrity & Compliance Officer (USICO) reports directly to the Deputy Compliance Officer (DCO) and assists the DCO with the day-to-day leadership and administration of the Indivior Global Integrity & Compliance Program (ICP). 

The USICO serves as a strategic business partner and advisor across the U.S. Business Units (Behavioral Health, Addiction Sciences, Opioid Reversal Sciences) and Global Functions residing in the U.S. (e.g., Medical Affairs, R&D, Managed Care, Marketing, Government Affairs, Corporate Communications) to ensure the effective integration and implementation of the Indivior Global Integrity & Compliance Program.  In this role the USICO will be responsible for providing timely proactive and daily compliance advisory counsel and compliant solutions approaches across the U.S. business, the annual administration of the U.S. I&C Risk Assessment and Mitigation Planning (RAMP) process with integration into the Global I&C RAMP, development/delivery of training, and participation in various compliance-related processes in collaboration with the Integrity & Compliance Centers of Excellence (e.g., monitoring, global strategy and program management, operations, reports communications, investigations (for subject matter expertise input only), governance committees, and government agreement administration).  

The USICO is responsible to provide sound guidance and solutions that are in full compliance with the terms of Indivior Inc. Resolution Agreement (including CIA, DOJ Compliance Measures and FTC agreement).

The USICO is appointed to serve as Chairperson of the U.S. Compliance Administration Council (and may appoint a responsible delegate) and lead the I&C’s policy governance program (with responsibility for all I&C Global and U.S. policies and procedures that are I&C-owned and in collaboration with those owned by other functions).

This position will have direct line reports and will also be responsible for indirect management of a network of Compliance Champions who support function level compliance activities.

 ESSENTIAL FUNCTIONS:  

• Work collaboratively in the development and evolution of the ICP, under the direction of the DCO and as guided by the Indivior Global Integrity & Compliance Program multi-year maturity strategy. USICO efforts will ensure effective and appropriately paced maturity within the Indivior U.S. Business Units, and U.S.-based Global functions in coordination with the I&C Officers.
• Lead and continually evolve the design, delivery and annual review of relevant I&C policies and SOPs based on U.S. laws, regulations, guidances, Industry Codes and Government Agreement requirements.
• Provide daily support and guidance and proactive risk and solutions identification as a business advisor to assigned U.S. Business Units and U.S.-based Global Functions. The USICO will embed and facilitate ongoing evolution of the Indivior Global Integrity & Compliance Program and effective support of corporate goals, in coordination with I&C Officers.
• Establish effective working relationships and build credibility within the Company, especially at senior management and operational leadership levels. The USICO will influence with and without direct authority to support a culture of integrity and compliance, confidence with quality decision making, and “speak up” without fear of retaliation.
• Lead a team that conduct the annual U.S. RAMP within the U.S. Business Units and functions, and advise senior management and operational leadership on issues concerning integrity and compliance matters including recommending controls designed to ensure compliance, while building independent Risk IQ across Indivior Business Units and Functions. The U.S. RAMP as a component of the Global I&C RAMP program must be executed in full conformance for consistency in approach and outcomes management. As such, the responsibility for the Global RAMP program is a shared responsibility between the USICO and the other I&C Officers.
• Build and develop highly engaged, effective team that consistently succeed in delivering value-added, timely, effective and pragmatic key stakeholder solutions that are risk and priority-based.
• Collaborate across Integrity & Compliance (I&C) to share insights from role, with active participation in the development of all relevant I&C activities, policies, training to ensure fit-for-purpose based on risk mitigation and business needs.
• Co-lead the effective design and delivery of relevant ad-hoc and standardized training for the U.S. Business Units and Functions together with the Global Training Center of Excellence.
• Engage in I&C monitoring and audits as assigned. In this role, the expectation is to conduct a moderate quantity of field observations to help inform awareness of business practices, risks and opportunities.
• Provide support for reports of concern assigned as “reviews” to the various functional areas for I&C advisory input.
• Serve as lead or member of assigned compliance governance committees, demonstrating strong policy and process development, administration and regular evolution skills.
• Engage in regular external networking and personal development to ensure maintenance of knowledge level of current regulations, Industry Codes and best practices (e.g., benchmarking), and strong working knowledge and application of Indivior policies and procedures, and all Indivior, Inc. Resolution Agreement requirements and commitments.
• Carrying out other tasks and activities related to the development, execution and maintenance of the ICP as assigned.
• Measure and report on Indivior Global I&C Program maturity initiatives and related progress, in addition to report development up to Board level for sufficient oversight based on the severity of any outcomes or matters under management (one on one, management committees, Board/Committees of the Board).
• Report on CIA compliance and implementation to U.S. Government Office of Inspector General Monitors at quarterly meetings as topics warrant; presence at all meetings.

KEY CHALLENGES:

• Engaging with diverse roles and individuals across U.S. region to ensure awareness, open dialogue and accessibility, while embedding confidence in ownership of compliance
• Providing timely, proactive and pragmatic approaches to deliver solutions to business needs and challenges within the governing standards of the Indivior Global Integrity & Compliance Program
• Effective time management and organization to manage multiple priorities, while simultaneously leading and driving key strategic priorities of the Integrity & Compliance function
• Create clarity through measurement and reporting of results delivered in role
• Effectively influencing quality decision making and change management while simultaneously driving an “operating with confidence” personal accountability; ensuring ownership and accountability for the ICP effectively rests with and is managed by the workforce at all levels of the organization

MINIMUM QUALIFICATIONS:

Education: BS/BA Undergraduate degree required.

Experience: Minimum 10 years of experience in either the pharmaceutical or medical device industry including a minimum of 5 years in a senior or regional healthcare compliance role and demonstrated experience effectively leading people in a supervisory capacity.

• Detailed understanding of U.S. regulations (including Industry Codes governing healthcare compliance programs).
• Strong interpersonal skills including ability to communicate effectively with people, individually and groups; ability to communicate with technical and non-technical colleagues; ability to develop important relationships with key stakeholders and work with all levels of management and employees, as well as with external partners and vendors.
• Excellent interpersonal, communication and presentation skills, with the ability to communicate complex issues in a simple way and influence for greater outcomes.
• Ability to work closely and collaboratively within Integrity & Compliance and with other business functions and Departments as well as key external stakeholders.
• Highly impactful people leader skills and an effective driver of the change management process.
• Experience in leading, planning, effectively executing and reporting on various healthcare compliance activities (e.g., training, risk management, monitoring).
• Effectively demonstrate expertise in Healthcare Compliance, leading to personal credibility and trusted advisor status among key stakeholder groups.
• Experience leading and advising within government agreement requirements and oversight is strongly preferred.

• Professional Compliance Certification required
• Law Degree or Master’s Degree not required, but is preferred.

COMPETENCIES/CONDUCT:

• Flexibility in thinking and pragmatic problem-solving skills
• Excellent interpersonal, communication and presentation skills
• Strong influencing skills and ability to exercise sound, consistent business judgment
• Ability to work independently and manage a diverse and demanding workload
• Willingness to work in a dynamic, fast-paced environment
• High standards of professional integrity and independence, maintaining essential confidentiality.
• Able to effectively influence senior management and functions to drive change
• Displays a high sense of urgency and responsiveness, with quality and accuracy
• Flexible to travel (minimum 40-60% of time)
• Tenacity and robustness
• Effectively demonstrate expertise in Healthcare Compliance, leading to personal credibility and trusted advisor status among key stakeholder groups

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 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, Dependent Care and Limited Purpose Flex Spending and HSA options
• Adoption assistance
• Tuition reimbursement
• Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Gym, fitness facility and cell phone discounts

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