Manager, Compliance- Americas

Chiesi Group • Cary, NC

2d • Hybrid

About The Position

Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity, inclusion, and equal opportunity are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Who we are looking forThis is what you will doThe Manager, Compliance- Americas will be responsible for serving as a Compliance business partner for Chiesi Colombia and Chiesi Canada business units by advising on and supporting Chiesi’s ethics and compliance programs, and ensuring compliance with Chiesi’s regional standard operating procedures, corporate policies, guidelines, and procedures, and applicable federal and local laws for the Americas. Essential position duties and responsibilities include but are not limited to: oversight and approver of assigned engagement activities with healthcare professionals, healthcare organizations, patients, and patient organizations, monitor data for compliance red flags and company trends, and provide oversight of certain internal and external reports.

Requirements

• Bachelor’s degree required
• Minimum of 3 years of corporate compliance experience, preferably in global pharmaceuticals role
• Knowledge of Colombian and Canadian markets, including pharmaceutical compliance regulations and standards
• Strong knowledge of applicable laws, rules, and regulations, including but not limited to, OIG, FDA, FCA, CMS, AKS
• Auditing and monitoring experience required
• Experience with federal and state aggregate spend reporting preferred
• Outstanding skills and experience in writing and modifying compliance guidelines
• People Management experience, preferred

Nice To Haves

• Bilingual in Spanish and English is strongly preferred; if not bilingual, proficiency in use of translation tools
• Excellent written, oral, and verbal communication skills across various audience types
• Demonstrated ability of energetic and contagious leadership related to compliance programs
• Ability to identify risk and determine risk mitigation pathways
• Strong leadership skills
• Detail-oriented
• Ability to review and understand data for purposes of auditing and investigations
• Ability to comprehend and work with complex business scenarios
• Excellent planning, organization and prioritization skills
• Highly proficient in Microsoft Office tools, specifically Outlook, Teams, Word, Excel and Powerpoint

Responsibilities

• Serve as Compliance’s main point of contact for Chiesi Colombia and Chiesi Canada, and assigned business units
• Develop, update and maintain appropriate policies, procedures and training to ensure compliance with local laws and regulations
• Respond to day-to-day compliance questions from management and field-based employees in a timely fashion.
• Provide guidance on the day-to-day compliance needs of the field- and office-based employees.
• Review and approve sponsorship, congress, and speaker program requests for Canada and Colombia
• Conduct audit activities in Canada and Colombia.
• Perform investigations related to compliance-related matters, as needed.
• Review interactions with healthcare professionals, key opinion leaders, researchers, and patients to confirm they are conducted in compliance with policies, including payments at a fair market value.
• Perform or support regular and ad hoc audits.
• Assist the Director, Compliance, Region America, Rare Diseases with annual planning for rare disease business units.
• Lead or assist Head of Compliance with system implementations and changes
• Provide general compliance support for core compliance functions as needed.
• Keep Director, Compliance, Region America, Rare Diseases and other business unit managers abreast of current activities.

Benefits

• We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support.
• Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
• Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 251-500 employees