Job ID: 2022-22112 Type: Remote - Full Time # of Openings: 1 Category: Legal B. Braun Medical Inc.
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.
Summary: The Director. Ethics & Compliance will have a significant role in the continued implementation and improvement of the corporate compliance program for the U.S. B. Braun Group of Companies. This position will work closely with the commercialization groups (such as sales, marketing and clinical) and the medical scientific affairs team, providing both compliance oversight (including a monitoring function) and supporting their operations as a value-added business partner. Responsibilities will include assisting with the management of the HCP consultant process, the development of written policies, procedures, and education as well as related communication, advice and council, monitoring, risk assessment, investigation, and reporting.
Principal Duties Responsibilities:
Provide consistent and timely guidance on compliance questions and issues that come up within the organization.
Collaborate cross-functionally across the organization to support the implementation of policies, systems and programs that drive organizational compliance with relevant laws, regulations, and standards. Develop additional policies, procedures, and guidance based on prioritized needs and risk assessments
Assist in monitoring all elements of the Company’s Compliance Program in accordance with OIG guidance.
Strategically monitor evolving federal, state and industry guidelines affecting the company’s overall U.S. healthcare compliance program and design and implement processes and procedures in order to ensure ongoing compliance.
Guide and assist with management of HCP consultant process; including ensuring legitimate business need, determining FMV, assisting with on-boarding and travel/invoicing approvals, tracking, and other considerations as needed within the process; assist with identifying and implementing tools and processes to manage HCP consultants compliantly and efficiently.
Develop compliance analytics methods, management reports, and perform analytics and monitor HCP spend data. Research and troubleshoot anomalies to identify and understand underlying business activities behind transactions.
Develop and track and maintain compliance dashboard(s) and provide periodic reporting.
Assist with management of all aspects of the Company’s Open Payments and transparency reporting.
Other duties as may be assigned to ensure robust compliance program.
Required Qualifications and Skills:
Education - Bachelor’s degree required; other advanced degree and compliance certification preferred (such as CCEP).
Years of Experience -10+ years of compliance experience; 8+ years medical device/pharmaceutical compliance experience preferred; experience conducting and implementing risk assessment programs; strong working knowledge and understanding of the relevant laws, regulations, and industry guidance regarding medical device or pharmaceutical industry interactions with healthcare providers (Anti-kickback Statute, False Claims Act, Open Payments reporting, and Foreign Corrupt Practices Act, AdvaMed, MDMA).
Technology - Proficiency in Microsoft Office Suite
Business Acumen - Understanding of basic business concepts, strategies, and risks. Uncompromising business ethics
Analytical Skills - Excellent judgment, strategic and analytical thinking, and the ability to assess risk and mitigations and make recommendations based on the company’s values, vision, business goals and risk appetite
Innovation - Strong problem-solving/creative skills that drive new business solutions
Project Management - Strong priority-setting skills, attention to detail and the ability to work on multiple projects at the same time
Communication - Excellent verbal and written communication skills to allow effective interaction with all levels of the organization with a work style that is decisive yet approachable.
Growth Mindset – Possesses a growth mindset with a passion for learning new things
Collaboration – Ability to thrive in a team environment; collaborate with industry compliance leaders
Diversity & Inclusion - Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
While performing the duties of this job, the employee is expected to:
Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Lifting, Carrying, Pushing, Pulling and Reaching:
Occasionally:Reaching upward and downward, Push/pull, Stand
Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking
Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick
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.
What We Offer
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its Sharing Expertise® initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Equal Opportunity Employer Veterans/Disabled
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.