Assistant General Counsel - Healthcare/Regulatory

Cencora is seeking an experienced healthcare regulatory attorney with significant experience advising and providing strategic leadership in the areas of FDA regulations, fraud and abuse law, CMS regulations and industry guidelines relating to healthcare entities, including pharmaceutical manufacturers, providers and related companies. This role will report to the VP, Data Governance and Regulatory within Cencora's legal team and focus on enterprise-wide initiatives and risk mitigation strategies.

This role requires a dynamic leader who will proactively collaborate with team members at all levels of the organization and offer pragmatic, solution-driven advice while managing risk within the highly regulated healthcare industry.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Regulatory Compliance: Provide expert legal counsel to senior management and commercial legal teams on a wide range of healthcare regulatory issues, including compliance with federal, state, and local regulations (e.g., Stark Law, Anti-Kickback Statute, False Claims Act, FDA regulations, and CMS guidelines).

• Risk Mitigation & Management: Identify, assess, and advise on potential legal risks associated with regulatory and operational activities. Develop strategies to mitigate risks and ensure compliance with evolving healthcare laws and regulations.

• Regulatory Monitoring: Stay abreast of regulatory and legal developments in the healthcare industry and ensure that the organization is prepared for changes in the regulatory landscape. Communicate potential risks and opportunities to senior management and other stakeholders.

• Government Relations & Agency Interactions: In collaboration with the regulatory and compliance teams, serve as a legal liaison with governmental agencies such as the Centers for Medicare & Medicaid Services (CMS), the Office of Inspector General (OIG), the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and other relevant regulatory bodies. Manage responses to audits, investigations, and regulatory inquiries.

• Transactional Support: Provide regulatory support in mergers, acquisitions, joint ventures, and other strategic business transactions involving healthcare providers, payers, and pharmaceutical companies. Conduct regulatory due diligence and advise on deal structures to minimize legal and regulatory risks.

• Healthcare Fraud and Abuse: Advise on compliance with federal and state healthcare fraud and abuse laws, including structuring business arrangements (e.g., physician compensation arrangements, referral agreements, and contracting structures) to comply with the Anti-Kickback Statute, Stark Law, and similar state laws.

• FDA and Pharmaceutical Guidelines: Provide guidance on drug development, approval, marketing, and post-market surveillance. Knowledge of PIE, transparency, price reporting, private label and country of origin a requirements a plus.

• Training and Education: Develop and lead internal training programs on regulatory matters, helping to ensure that key stakeholders, including compliance teams, business leaders, and staff, understand and comply with healthcare regulatory requirements.

• Contractual Review and Compliance: Review and provide legal guidance on healthcare-related agreements, including payer/provider contracts, supplier agreements, and vendor relationships, to ensure compliance with healthcare regulations and industry best practices.

• The Assistant General Counsel should have strong decision-making capability and should be proficient in being able to make business-oriented yet legally compliant recommendations to his or her clients

• The Assistant General Counsel is expected to solve both straightforward and complex problems and take a new perspective on existing solutions.

• The lawyer in this role should be able to juggle multiple matters and effectively multi-task and prioritize tasks to ensure that work is completed in a timely and efficient matter.

• The Assistant General Counsel will effectively work in the midst of change and is willing to shift priorities and focus.

• The lawyer in this role will seek out challenging tasks and assignments, engage in frequent development discussions and is open to feedback.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

The lawyer in this role has the expertise and background to be comfortable supervising outside lawyers engaged to work on matters for Cencora, including outside lawyers from major law firms used by Cencora.

In this role, the lawyer is expected to be knowledgeable in Cencora's business and industry policies, practices and trends and be aware of the competitive landscape.

Relies on extensive experience and judgment to plan and accomplish goals.

Ability to communicate effectively both orally and in writing.

Strong interpersonal skills

Strong creativity skills

Excellent judgment and ability to resolve complex issues effectively

Ability to follow and interpret legal trends

Knowledge of Microsoft Word, Excel and PowerPoint

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an associate encounter 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 generally quiet.

PHYSICAL AND MENTAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:

Sedentary physical activity requiring reaching, sifting, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing.

Visual requirement is for close vision, distance vision, peripheral vision, and ability to adjust focus.

75% or more time is spent looking directly at a computer.

Associate is frequently required to stand, walk (or otherwise be mobile).

Ability to deal with stressful situations as they arise.