Avanir Pharmaceuticals

Manager, Compliance

Location
Aliso Viejo, CA
Posted
Apr 13, 2021
Ref
R2628
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The Manager Compliance, assists the Compliance department in developing, implementing and maintaining an effective Corporate Compliance Program that: Supports and promotes a company-wide culture of ethics and compliance; Ensures the company's compliance with all applicable federal and state health care laws and regulations, and industry codes of conduct; and Meets or exceeds the standards set forth in the U.S. Sentencing Guidelines and 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers.

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.

Education/ Qualifications:

  • Bachelor’s degree required. Advanced degree, e.g., J.D., Masters, PhD, etc., a plus
  • 5+ years of pharmaceutical compliance experience
  • Excellent communication skills, with the confidence, credibility, and ability to work effectively within the organization and interact with both junior and senior business personnel
  • Strong organizational skills with the ability to multitask and prioritize
  • Experience with cross functional collaboration
  • Proficiency in Microsoft Office Suite: Outlook, Excel, Word, PowerPoint
  • Experience developing comprehensive spreadsheets
  • Strong ethics and integrity.
  • Ability to work independently with minimal supervision.
  • Demonstrated ability to exercise independent judgment with knowledge of the pharmaceutical industry.
  • Knowledge of various laws, regulations, and industry guidance that affect the company’s compliance program, including 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, and the False Claims Act and anti-kickback statutes.
  • Experience with monitoring and auditing pharmaceutical company activities.
  • Demonstrated ability to build and manage effective relationships with strong inter-personal skills and business acumen.
  • Effective time management skills and ability to handle multiple projects simultaneously

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.