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DIRECTOR, COMPLIANCE RISK, MONITORING & ANALYTICS - Indivior
Reports To: Chief Integrity & Compliance Officer
Location: Richmond, VA US
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 Director, Compliance Risk, Monitoring & Analytics will be responsible for strategic leadership and regular evolution of Indivior's healthcare compliance Risk Assessment & Management Plan (RAMP) process and related compliance monitoring program. This includes managing internal and external resources in the performance of systems and process audits of compliance with U.S. federal and state laws and regulations related to the promotion, sale and marketing of Indivior therapies, in addition to potential monitoring and auditing activities based on requirements outside the United States. In addition, this role requires analyzing and interpreting large volumes of data to facilitate the communication of key insights and findings to key stakeholders and business partners. This role has the additional responsibility of leading the development and implementation of compliance program effectiveness analytics related to the RAMP and monitoring processes, and broader compliance program elements (e.g., training, investigations). These responsibilities include quality and comprehensive documentation in systems and tools to assist the organization in implementing its effective compliance program.
ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following in order to assist the Chief Integrity & Compliance Officer, in:
- Leading the administration and regular enhancement of Indivior's Risk Assessment and Management Plan policies and processes
- Leading the administration and regular enhancement of Indivior's risk-based monitoring program policy and processes designed to help ensure compliance with healthcare laws, regulations and guidance (such as the Anti-Kickback Statute, False Claims Act, OIG Guidance for Pharmaceutical Manufacturers, PhRMA Code & FDCA), and detect and prevent potential fraud and non-compliance, and any other related Indivior requirements
- Driving the process of assessing, monitoring and mitigating compliance risks across commercial and non-commercial functions by developing, enhancing and executing the compliance audit and monitoring programs, including the performance of field rides, with potential coordination and management of external resources as warranted and in collaboration with other assurance functions (e.g., Internal Audit); This will require personal engagement in the conduct of such activities, as well as management of the team's performance implementation of these activities
- Performing detailed transactional audits, potentially including: engagement of assorted third-parties; research and educational grant funding; and other non-promotional practices
- Leading the phased development and execution of relevant compliance activity and outcome analytics, with ongoing evolution, to aid our ability to assess the effectiveness of Indivior's compliance program elements
The job further requires the Director, Compliance Risk, Monitoring & Analytics to:
- Maintain strong subject matter expertise through engagement in external programs and conferences and relevant benchmarking to provide sound advice and guidance to business partners regarding compliance policy, processes and issue management, and in the development of team
- Design and deliver meaningful, accurate and effective presentations to senior management and ensure follow-up on any areas that require corrective action
- Oversee the management and maintenance of various systems and tools related to RAMP, monitoring and analytics, and recommend enhancements to the same
- Assist in preparation for all external inquiries and audits and/or internal reviews of systems or processes
- Assist with identification of any relevant systemic corrective actions and related implementation based on results of RAMP, monitoring and analytics
- Identify, develop and help implement enhanced monitoring controls as warranted
- Be able to handle all matters as confidential, demonstrate an ability to effectively and continually prioritize, and identify new issues requiring attention in a risk-based manner and help drive resolution within and beyond scope of responsibility
- Additionally, this role requires the ability to identify matters that require elevation to senior management on mitigation of risk and improving the effectiveness of the compliance program.
Education: Undergraduate degree required
Experience: At least 9 - 12 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 Chief Integrity & Compliance Officer
In addition to the minimum qualifications, the employee will demonstrate:
- Effective team management skills across the full continuum of recruitment, coaching, performance management and employee development, while developing a high performing and collaborative team
- Proven ability to build and lead the execution and management of compliance monitoring programs, and to execute audit plans and conduct compliance systems review audits with minimal supervision
- Advanced data analytics and data mining skills
- Strong project management skills; with the ability to drive execution by team members and others
- High level problem solving, judgment, detail-oriented and 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, under challenging conditions 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
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.
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
MANAGER, COMPLIANCE - Chiesi USA
Location: Cary, NC US
- We want to be recognized as an international group focused on research, able to develop and commercialize innovative therapeutic solutions to improve the quality of people's lives.
- We intend to maintain a high-quality entrepreneurial team, characterized by a spirit of cooperation and self-confidence.
- Our goal is to combine commitment to results with integrity while operating responsibly from both a social and environmental point of view.
Job Purpose: The Manager, Compliance, will be responsible for supporting ethics and compliance programs and ensuring compliance with Chiesi USA's standard operating procedures, corporate policies, guidelines, and procedures, and applicable federal and state laws. Essential position duties and responsibilities include but are not limited to: policy writing and policy updates; oversight of Aggregate Spend Reporting; Third Party Vendor management; Compliance training initiatives; audit planning and audits.
General Function/Specific Responsibilities:
- Update policies, procedures and training to ensure regulatory environment and changes
- Develop appropriate policies, procedures and training to ensure commercial compliance readiness
- Identify and implement process improvements and enhancements to the Compliance program
- Develop appropriate compliance training courses for employees and related third parties
- Perform compliance training at onboarding, annually, and periodically through live, remote, and electronic means
- Respond to day-to-day compliance questions from the management of field-based employees in a timely fashion
- Oversee the day-to-day compliance needs of the field-based employees
- Oversee the federal and state aggregate spend filings
- Perform investigations related to compliance-related matters
- Manage third-party compliance vendor agreement renewals and purchase orders
- Participate in screening process for healthcare related agreements and third-party entities
- Ensure interactions with healthcare professionals, key opinion leaders, researchers, and patients are conducted in an ethical manner
- Perform and/or participate in regular and ad hoc audits
- Assist VP, Compliance, with annual audit plan
- Assist VP, Compliance, on system implementations and changes
- Provide general Compliance support of all the compliance units
- Create monthly management reports for VP, Compliance, and Monthly Management report
Requirements for Position:
Education and Experience
- Bachelor's degree required
- Minimum of 3 years of corporate compliance experience, preferably in pharmaceuticals
- Strong knowledge of applicable laws, rules, and regulations, including but not limited to, OIG, FDA, FCA, CMS, AKS
- Auditing and monitoring experience required
- Experience with federal and state aggregate spend reporting preferred
- Outstanding skills and experience in writing and modifying compliance guidelines
- People Management experience, preferred
Essential Skills and Abilities
- Excellent written, oral, and verbal communication skills across various audience types
- Demonstrated ability of energetic and contagious leadership related to compliance programsC
- Ability to identify risk and determine risk mitigation pathways
- Strong leadership skills
- Ability to review and understand data for purposes of auditing and investigations
- Ability to comprehend and work with complex business scenarios
- Excellent planning, organization and prioritization skills
- Highly proficient in Microsoft Office tools, specifically Outlook, Teams, Word, Excel and PowerPoint
Direct Reports: Yes
Direct Reports: N/A
Confidential Data: Yes
- Clean, quiet and professional working environment
- Computerized office conditions
- Minimal travel required
SENIOR COMPLIANCE OPERATIONS MANAGER - Exelixis
Location: Alameda, CA US
Salary Grade: 10
Divisions: General & Administrative
Job Code: 1405
Department: Healthcare Compliance
FLSA Status: Exempt
Reports To: SVP, Healthcare Compliance
Effective Date: April 2020
The Compliance Operations Senior Manager will be responsible for the development, implementation, and continuous improvement of healthcare compliance practices, systems, and processes, with an emphasis on business integrity, operational excellence, and practicality. One primary focus will be supporting Development on healthcare compliance, anti-bribery/anti-corruption, antitrust, publication, privacy and data management issues. As part of this support, this position will be responsible for evaluating materials submitted for review and approval, performing audits, and conducting training related to interactions with the healthcare community. Another responsibility will be management of the process for tracking and reporting HCP spend. Of similar priority will be supporting and enhancing the Company's healthcare compliance monitoring program. The essential business partners for this function are corresponding positions in Development, Medical Affairs, Commercial, QA, IT, and Finance.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Works on a range of departmental and/or strategic problems where analysis of situations or data requires critical thinking, an in-depth evaluation, and company knowledge of various factors. May also be required to manage external consultant engagements, when needed, including overall budgets, schedules, and performance standards.
- Leads the ongoing fulfillment of the company's HCP spend tracking and reporting obligations under the ACA's Sunshine Act provisions and related state laws regulating HCP spend by drug manufacturers or requiring state tracking and reporting. Applies advanced technical expertise in this arena and supports goals with an understanding of priority and impact to the program, department and organization.
- Support execution of the audit and monitoring program, including development of tools, performance standards, and completion of corrective action. In conducting compliance assessments, the team lead will need to be a strategic partner to R&D to ensure that the compliance program evolves as the company grows.
- Acts as a consultant, reviewer and legal/compliance approver as needed, for business activities that involve Healthcare Compliance risks, and contributes to departmental process and organizational improvements and development, including management of the contract request process for HCP engagements. In addition, participates in reviews of requests for approval of Development activities.
- Assists with the company's Healthcare Compliance continuous improvement initiatives, including but not limited to, partnering with Quality Assurance to develop processes and training related to healthcare compliance, corruption, antitrust, publication, privacy and data management risks. GxP experience is a plus.
- Leverages data analytic skills to proactively address potential healthcare/FDA compliance issues to prevent or minimize compliance risk to the company. Works with internal stakeholders to achieve business goals within a compliance framework.
- Participates in the investigation of complaints and alleged violations of rules, regulations, policies, procedures, and standards of conduct, and coordinates with management in developing/implementing corrective action plans and providing general guidance on such matters.
- Regularly reviews reports of new compliance developments from governmental agencies such as the OIG and state agencies, including fraud alerts, special advisories or proposed rules and, in conjunction with the legal department, to ensure appropriate interpretation and training regarding such developments.
- BS/BA degree in related discipline and eight years of related experience; or,
- MS/MA degree in related discipline and six years of related experience; or,
- Equivalent combination of education and/or experience.
- Specific expertise in the best practices of healthcare compliance and auditing. Finance audit experience is a plus.
- Familiarity with the legal principles of FDA advertising and promotion regulations, the False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code required.
- Experience with Polaris software and/or Tableau is a plus.
- Excellent verbal and written communication skills, must be an effective communicator with strong interpersonal skills
- Strong organizational (detail oriented), project management, and problem-solving skills
- Ability to handle multiple tasks, prioritize appropriately and adapt quickly to new situations, and offer creative solutions to challenging problems
- Must be responsible, conscientious, and professional
- Ability to work under pressure to meet specific deadlines
- Ability to work independently and also be a team player
- Must be able to exercise common sense in carrying out tasks
- Dedication to quality and the highest professional standards
- Must be a self-starter and quick learner
- Must have good judgment
- Strong computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint, etc.), Visio, Internet)
- Ability to travel
- Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
- Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
- Networks with key contacts outside own area of expertise.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.