Avanir Pharmaceuticals

Chief Privacy Officer & Assistant General Counsel, Commercial

Location
Aliso Viejo, CA
Posted
Jan 18, 2022
Ref
R2663
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
The Chief Privacy Officer & Assistant General Counsel will be a lead commercial and privacy attorney providing business-focused strategic counsel on a broad array of commercial and privacy related matters in support of the Company’s product portfolio and product candidates including matters of advertising and promotional review, compliance, FDA pharmaceutical regulations and requirements, patient assistance programs and educational programs as well as he/she will lead the Avanir Privacy Office and counsel the business on all aspects of privacy laws and regulations. This position will report will work collaboratively cross-functionally.

Essential Job Functions:

  • Serve as the lead attorney and strategic advisor for a wide range of regulatory matters including: Fraud and Abuse, Stark/Anti-Kickback issues, FDA marketing (advertising, promotion, labelling) and other FDA regulatory matters, anti-bribery laws, privacy law, PhRMA Code, OIG guidance.  Advise on impact of proposed legislation and reporting requirements (state and federal), and other healthcare regulatory matters.
  • Serve as the lead attorney advising on all aspects of applicable privacy laws and lead the company’s Privacy Office, including assuring the company’s compliance with applicable privacy laws
  • Advise and consult with all levels of the organization including senior leadership to identify critical legal issues, assess potential legal options, and provide individuals and teams with an analysis and range of possible legal solutions
  • Partner with Compliance Team in the implementation and continued education of the Company’s company-wide compliance program
  • Partner with teams to establish a rapport and a positive working relationship, particularly within the corporate office and Field Commercial Team, to encourage and continue engagement of legal counsel in the achievement of objectives and goals
  • Review, analyze and advise for each therapeutic area, matters related to reimbursement activities, access services, patient support and assistance programs
  • Partner with Compliance and Business teams to ensure policies and procedures meet internal and regulatory standards
  • Understand regulatory and business context and ability to shape content to fit within the company’s prescribed policy framework
  • Negotiate with sophisticated counterparties, such as hospitals, academic institutions and clinical research organizations
  • Providing legal advice for a wide range of matters, including product pricing and corporate communications and governance
  • Leadership:  Identify training needs within Avanir and develop and present training materials on relevant legal issues. Develop a thorough understanding of the company’s business, its people, products, customers and competitors to provide strategic guidance to internal clients. Participate in conferences, regulatory meetings and trade associations and communicate real time with internal clients about the changing environment.

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:

  • JD from an accredited law school
  • Strong academic credentials
  • 6+ years of experience as an attorney in a large law firm, biopharmaceutical company, or in a major government agency practicing law related to biotechnology, pharmaceutical, device and/or healthcare
  • Broad-based knowledge of laws and regulations governing pharmaceutical activities with a focus on commercial activities and privacy matters
  • Ability to prioritize and follow through on diverse issues on a timely basis; self-starter, resourceful and able to participate in a highly collaborative, cross-functional team-oriented environment; meet demanding deadlines and manage multi-dimensional projects.
  • Must have proven skills in analyzing and solving complex legal issues, developing solutions, identifying opportunities and in managing complex legal projects
  • Positive communication style with demonstrated ability to creatively navigate and successfully drive results in a fast-paced, flexible work environment
  • A high standard of ethics
  • Exceptional written and verbal communications skills – able to effectively collaborate and communicate with stakeholders throughout the company
  • Proficient with all MS Office application skills

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.