Compliance Specialist I

Date:  Nov 23, 2022
Department:  Scientific 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 Specialist I is primarily responsible for field-facing activities such as aggregate spend reporting, licensing, credentialing, and certifications. The Compliance Specialist I will be the primary compliance contact for the field on operational matters, as well as assisting with 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

  • Addressing field-facing personnel needs related to:
  • credentials required to enter the hospital or clinic (certificates of insurance, training, certificates, etc.)
  • Ensuring representatives have appropriate licenses in required areas
  • HCP license look-ups and remediations
  • Promotional material recordation
  • Textbook program 
  • Other field-related compliance needs 
  • Completing the Federal Aggregate Spend General Payments Report
  • Assisting with State Aggregate Spend reports
  • Monitoring activities that are reported in the Report, particularly in-services and speaker program expenditures
  • Policy, procedure, and guideline updates as needed; job aid creation, communication

Experience Required

  • Experience at a pharmaceutical, biotechnology or medical device company a plus, with preference to those with experience in pharmaceutical compliance 
  • Demonstrated knowledge and understanding of healthcare compliance issues, including the applicable legal and regulatory framework governing aggregate spend, federal and state reporting.
  • 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 an 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 audit, finance, accounting, or data analytics, 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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