Date: Apr 22, 2024
Department: Legal & Corporate Affairs
Job Type: Direct Employee
Team: Legal, Compliance & Internal Audit
Contract Type: Permanent
Location:
Cary, NC, US
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.
What we offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."
Purpose
The Compliance Analyst is primarily responsible for preparing and filing all required federal and state reports and certifications. The Compliance Analyst will manage key aspects of the Company’s aggregate spend reporting program, including the tracking, auditing, monitoring, managing and reporting of the Company’s aggregate spend with healthcare professionals (HCPs) and healthcare organizations (HCOs), as well as playing an active role in the development of associated business processes, systems and tools.
Main Responsibilities

• Lead the preparation and submission of required federal, state and other reports, certifications, and payment of reporting fees. In addition, will draft responses to any inquiries from government entities, regulatory authorities, industry groups, HCPs and other third parties relating to the reports or their underlying data.
• Partner with the Compliance Lead for Aggregate Spend reporting on the implementation of the Federal Sunshine Act regulations, including system modifications, process/procedure modifications, and the creation of an HCP dispute resolution process.
• Perform weekly random audits of Chiesi employee expenses related to HCPs and HCOs; determine if further audits or investigations are required when infractions to policy are discovered
• Manage the analysis and compilation of data necessary to satisfy the Company's federal, state and other reporting requirements, including ensuring system templates are accurately set-up to capture data based on the Company’s interpretation of the laws/regulations, identifying and resolving potential data gaps and data integrity issues, and analyzing HCP payment records for compliance with laws, regulations, and company policy.
• Research and stay current with applicable federal and state legislative and regulatory reporting requirements (i.e., analyze federal and state communications, attends industry conferences, consults with industry counterparts and experts and proactively recommends best data collection and reporting practices).
• Assist in drafting and implementing policies, procedures, and training materials.
• Assist in training new personnel on the Company’s Aggregate Spend and Compliance Policies; create and provide on-going training for all Chiesi personnel.
• Work closely with colleagues across the organization to ensure accurate data collection and reporting, including working with Finance, Sales, Marketing, Scientific Affairs, Medical Affairs, IT and other departments.
• Work closely with VP, Compliance to interpret laws and regulations and determine how they apply to the Company’s business operations.
• Independently manage tasks and projects related to credentialing of commercial personnel and aggregate spend.
• Liaise with US HCPs who are contracted with affiliates to ensure payments are made and captured for reporting.
• Accomplish other objectives and responsibilities as identified by manager.

Experience Required

• Experience at a pharmaceutical, biotechnology or medical device company a plus, with preference to those with experience in healthcare compliance
• Demonstrated knowledge and understanding of healthcare compliance issues and the applicable legal and regulatory framework governing aggregate spend, federal and state reporting.
• Knowledge of Sunshine Act, preferably experience with Open Payments
• Proficient in MS Office (Word, Excel, Project), Adobe and ISI Toolbox.
• Excellent written and verbal communication skills across various audience types
• Demonstrated project management skills, including the ability to effectively plan, prioritize, and execute projects in a timely manner
• Ability to collaborate with multiple functional units and interact with colleagues with appropriate respect and sensitivity
• Pays careful attention to detail and excellent document management skills
• Demonstrated initiative and problem-solving skills, including the ability to proactively identify issues, anticipate needs and develop practical, meaningful solutions
• Must demonstrate a high level of proficiency with the Microsoft Office Suite
• Ability to comprehend and work with complex business scenarios
• Excellent planning, organization and prioritization skills
• Outstanding skills/proven track record in writing and modifying departmental SOPs
• Ability to work on multiple projects simultaneously with little or no supervision under tight deadlines
• Ability to determine methods and procedures on new assignments

Education

• A Bachelor's degree, ideally with an emphasis in finance or accounting, or equivalent experience

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
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