Description:
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 53 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics' global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 70 countries outside the United States. For more information, please visit www.orthopediatrics.com.General Summary: The Healthcare Compliance Director/Privacy & Commercial Counsel (HCDPCC) is primarily responsible for identifying and assessing areas of healthcare compliance risk for the Company. The HCDPCC provides direction and oversight of the Company's Healthcare Compliance Program, including communicating the importance of the Healthcare Compliance Program company-wide and collaborating with Executive Management to effectively incorporate the Healthcare Compliance Program within system operations and programs and to carry out the responsibilities of the position. The HCDPCC has direct access to all employees and representatives, including Executive Management and Board of Directors. Moreover, the HCDPCC collaborates with other legal professionals within the Company's Legal Department to address healthcare privacy issues and to assist commercial transactions.
Essential Functions:
- Provide counsel to the Company on a wide range of healthcare compliance and data privacy issues.
- Oversee the Company's Healthcare Compliance Program, including the management of the Company's learning platform and the preparation of new hire and annual training and education courses.
- Manage the Medical Affairs Committee's procedure for nominating and approving physician consultants and completing the regular review of consulting agreements with the assistance of the Company's Paralegal.
- Develop and maintain company policies and procedures in the areas of privacy and healthcare compliance, including Company's Code of Ethics and Business Conduct Policy and HIPAA privacy and security policies.
- Complete due diligence of potential business partners and monitor regular sanction checks, including the coordination of FCPA searches with the assistance of outside counsel.
- Coordinate and complete investigations or corrective actions in the rare event of an alleged privacy breach or compliance violation.
- Assist Privacy Officers in responding to HIPAA related requests for access to medical records.
- Promote OrthoPediatrics' culture of compliance by fostering regular communication and education.
- Provide support in the areas of financial reporting, business filings, and corporate governance.
- Assist the Company's General Counsel and Associate General Counsel in the daily preparation and review of commercial transactions, including for example pricing agreements, distribution agreements, software and licensing agreements, data sharing agreements, consulting agreements, and marketing materials.
Supervisory Responsibilities: There are no supervisor responsibilities with this position currently.
Qualifications: To perform this job successfully, an individual must be able to perform each essential function satisfactorily. (The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
- Thorough knowledge and understanding of applicable legal and regulatory environment as it relates to medical technology companies, including anti-bribery and anti-kickback laws, Foreign Corrupt Practices Act (FCPA), Medicare fraud prevention, Physician Payments Sunshine Act, etc.
- Strong healthcare compliance and data privacy experiences
- Executive presence with ability to inspire confidence and hold the trust of employee and senior management
- Strong work ethic and commitment to excellence with unquestioned integrity and excellent judgment
- Strategic thinker and problem solver with the ability to be hands-on when needed
- Proven ability to develop strong, positive, and collaborative relationships across all functional areas and levels within the organization
- Strong communication skills (both presentation and written)
- Ability to thrive in a fast-paced, ever-changing, and collaborative environment
- Proficient in Microsoft Office products, related business applications and office equipment
Education and/or Experience:
- JD or equivalent from an accredited university and licensed and in good standing with at least one state bar
- 2-5+ years' experience within a legal department and or within a medical technology company or comparable relevant legal experience
Language Skills: Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and correspondence. Ability to communicate effectively with customers, vendors, and other employees of the organization. Requires excellent grammar and spelling.
Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Certificates, Licenses, Registrations: Requires a valid driver's license.
Other Skills and Abilities: Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc. Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint.
Physical Demands: (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.)
While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel. The employee is frequently required to climb stairs, talk and hear. The employee is occasionally required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.
Work Environment: (The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
The noise level in the work environment is that found in a “normal office environment; noise levels during visits to other locations in the building may be moderate and occasionally loud. The employee occasionally performs work related to travel.
The above statement reflects the general details necessary to describe the principal functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.