Senior Manager, Compliance
Essential Job Functions:
- 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 page
- 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
- Business Acumen: 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, PDMA, AMA, and industry guidance documents, regulations regarding the promotion of marketed products, clinical trial regulations, and the False Claims Act and anti-kickback statutes
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.
- Bachelor’s degree required. Advanced degree, e.g. J.D., Masters, PhD, etc., a plus
- 10+ years of experience in pharmaceutical industry including at least 4+ years management experience. Or a combination of at least 5+ years of experience in a pharmaceutical manufacturing health care compliance program and the remaining years of experience in related field
- Experience working with corporate integrity agreements highly preferred
- The person performing in this position is expected to possess the following qualifications: Demonstrated strong ethics and integrity; Ability to work independently without 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; 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; 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
- Ability to travel, approximately 5% of working time
- Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)
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.
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.
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.