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Director, Compliance

Company: Avanir Pharmaceuticals Inc.
Location: Aliso Viejo
Posted on: April 2, 2021

Job Description:

The Director of Compliance assists in developing, implementing and maintaining an effective Corporate Compliance Program that supports and promotes (1) a company-wide culture of ethics and compliance; (2) compliance with the Company's Corporate Integrity Agreement (CIA) and Deferred Prosecution Agreement (DPA) obligations and (3) a compliance program that meets or exceeds current regulatory standards for effective compliance programs, including the Office of Inspector General (OIG) Guidelines, the U.S. Federal Sentencing Guidelines, and the Department of Justice (DOJ) guidance. Ensures the Company's compliance with all applicable federal and state health care laws and regulations, and industry codes of conduct. This position requires the flexibility and knowledge to support all elements of Avanir's Compliance Program.Essential Job Functions:Incumbent must possess and maintain up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct and developments, and best practices applicable to the company's policies, practices or operations, including but not limited to the 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, Prescription Drug Marketing Act (PDMA), American Medical Association (AMA), and industry guidance documents, regulations regarding the promotion of marketed products, clinical trial regulations, and the False Claims Act and anti-kickback statutes. In addition, leadership and management skills are necessary as the role will have responsibility for managing of a team of employees with a focus on Written Standards, Training and Communications, which includes:

  • Written Standards: Develops, revises, updates and maintains compliance policies, procedures and other written standards; Collaborates with other departments within the Company in addressing their policies, procedures and other written standards relating to or impacting the Company's healthcare compliance program.
  • Training & Communication: Develops, implements, tracks and measures employee training on all compliance policies, applicable laws, regulations and industry developments impacting the Company's health care compliance; Develops and implements the compliance component of new employee orientation collaborating with relevant other departments of the Company to do so; Develops and delivers compliance training at Company and departmental meetings; Develops, maintains and publicizes the Compliance department's internal compliance SharePoint pageAdditional responsibilities include collaborating with and assisting other areas of Compliance including:
    • Auditing & Monitoring: Assist with Compliance auditing and monitoring activities related to promotional and non-promotional activities.
    • Risk Assessment: Assist with annual evaluation and identification of risks associated with business activities and establish mitigation plans based on identified risks.
    • Business Partnership: Collaborate with key stakeholders (e.g., Sales, Marketing, Medical Affairs, Clinical) to address questions and issues, and implement compliance work plans.This--job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.Education/ Qualifications:
      • Bachelor's degree required. Advanced degree, e.g. J.D., Masters, PhD, etc., a plus.
      • Minimum of 14 years of compliance experience in the pharmaceutical or device industry.
      • Significant experience managing compliance within the context of a CIA and DPA highly desirable.
      • 7+ years of experience in people management and managing budgets.
      • The person performing in this position is expected to possess the following qualifications:
        • Strong ethics and integrity.
        • Ability to work independently with no routine supervision.
        • Demonstrated ability to exercise independent judgment with knowledge of the pharmaceutical industry.
        • Strong interpersonal skills and collaborative ability.
        • Strong analytical skills and demonstrated ability to successfully perform multiple projects in a timely and effective manner.
        • The ability to work under pressure and meet deadlines.
        • Excellent planning, project management and research skills.
        • Ability to analyze data, develop and maintain databases, and generate formal written reports.
        • The ability to communicate, orally and in writing, effectively and persuasively.
        • Track record for successfully working cross-functionally on a wide range of pharmaceutical compliance activities.
        • Experience in creating and implementing training programs including strong speaking skills.
        • Ability to identify problems, explore options and recommend solutions through strong critical thinking, problem solving and decision-making skills.
        • Effective at managing, synthesizing and communicating complex information.
        • Demonstrated experience in handling confidential and sensitive situations or information with ability to exercise a high degree of judgment and discretion while maintaining strict confidentiality as required.
        • The ability to travel from time to time.
        • Ability to manage people and third-party vendors effectively.
        • Ability to manage budgets effectively.
        • Ability to manage complex cross functional initiatives.
        • Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)Physical Requirements:This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver's license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.Work Environment:While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.EEO Statement:As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination.-- Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities. Posted 2 Days Ago Full time R2559 About Us Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit http://www.avanir.com

          Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en

          Avanir-- is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries

Keywords: Avanir Pharmaceuticals Inc., Aliso Viejo , Director, Compliance, Executive , Aliso Viejo, California

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