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The North American Compliance Counsel will help lead the Company's Corporate Compliance Program, reporting to the Chief Regulatory and Compliance Officer, and working closely with other cross functional teams including Legal, Commercial, Marketing, Regulatory and Quality, Audit and Finance, to develop, implement and maintain a comprehensive program that meets all applicable regulatory requirements and industry standards.
PRIMARY DUTIES/RESPONSIBILITIES
In the table below, briefly describe primary duties/responsibilities of this job in 5-8 bullet points in decreasing order of priority.
Support the implementation, and maintenance of North America corporate compliance activities, focusing on developing, updating and counseling on U.S. compliance policies, and pharmacy compliance regulations, as well as supporting internal compliance investigations.
Provide legal analysis and risk-based recommendations regarding compliance rules and regulations (e.g., advertising and promotion, anti-kickback, federal and state pharmacy law, state consumer regulations, and false claims act statutes) implicated by proposed business strategies.
Maintain current understanding of laws and regulations applicable to pharmaceutical compliance, along with recent industry trends and changes.
Lead Global Compliance Steering Committee
In conjunction with Chief Regulatory and Compliance Officer, develop and lead annual training and identify additional training opportunities for business unit clients.
Support Chief Compliance Officer in development and execution of Annual Compliance Plan.
Other duties as needed or required.
COMPETENCIES/SKILLS:
Advanced knowledge of corporate compliance program requirements
Excellent writing skills
Excellent communication skills
Excellent research skills
Excellent administrative and organizational skills
Deals with confidential information and/or issues using discretion and judgment.
EDUCATION REQUIREMENTS PREFERRED
Bachelor's degree and JD required;
Admission to and good standing with at least one state bar.
RELATED EXPERIENCE REQUIREMENTS PREFERRED/QUALIFICATIONS
8-10 years of experience working in the pharmaceutical/healthcare legal/compliance/internal audit field. Experience in-house, at a regulatory agency, or at a major law firm also welcome.
Experience with and/or understanding of compliance issues confronting the pharmaceutical, biotechnology, and/or healthcare industry generally.
Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, FDA regulations on the promotion of marketed products, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act.
Ability to communicate effectively at all levels of the organization, up to and including executive leadership.
Comfortable with independent decision-making
Remote US
Salary may vary depending on factors such as confirmed job-related skills, experience, and location.
However, the pay range for this position is as follows.
$126,200.00 - $234,400.00We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program:
* 401k savings & company match
* Paid time off
* Paid holidays
* Maternity leave
* Parental leave
* Military leave
* Other leaves of absence
* Health, dental, and vision benefits
* Health savings accounts
* Flexible spending accounts
* Life & disability benefits
* Identity theft protection
* Pet insurance
* Sales Positions are eligible for a Variable Incentive
* Certain positions may include eligibility for a short term incentive plan
Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Henry Schein Animal Health is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, and/or disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.