Director Commercial Compliance
Cencora
If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. The Director, Commercial Compliance serves as the primary Compliance partner for U.S. pharmaceutical and biosimilar commercialization. The role leads the development and oversight of a risk-based compliance framework for commercialization, advises senior leaders, and provides independent challenge on higher-risk business decisions. USA - Remote
Lead a risk-based commercial compliance strategy aligned with commercialization priorities and business growth.
Advise senior leaders and cross-functional teams on pharmaceutical promotion, HCP and patient interactions, patient-support programs, Medical Affairs independence, medical information, market access, pricing, government price reporting, and other commercialization risks.
Develop and operationalize compliance policies, procedures, governance, training, certifications, guidance, documentation, and escalation standards for commercial activities.
Establish controls that protect independent decision-making, confidential information, appropriate access, and management of actual or perceived conflicts of interest.
Design and oversee commercial compliance risk assessments, monitoring, testing, investigations support, issue escalation, corrective action, and validation of remediation.
Assess new commercial programs, partnerships, channels, and operating models to identify compliance requirements and address control gaps.
Provide compliance guidance regarding interactions and arrangements with GPOs, distributors, MSOs, specialty pharmacies, provider organizations, and other commercial partners.
Partner with Legal, Regulatory, Medical, Quality, Commercial, Market Access, Technology, Audit, and other control functions to embed clear compliance accountabilities.
Provide concise executive reporting on material risks, compliance readiness, control effectiveness, trends, resource needs, and unresolved issues.
Promote ethical decision-making, speak-up culture, and individual accountability through visible leadership and practical compliance guidance.
Bachelors degree in business, life sciences, healthcare, public policy, compliance, or a related field; advanced degree or relevant compliance certification preferred.
Minimum of 10 years of progressive pharmaceutical, biotechnology, healthcare, or life-sciences compliance experience, including substantial U.S. commercial compliance responsibility.
Demonstrated experience developing, implementing, or enhancing a pharmaceutical commercial compliance program across ongoing commercialization activities.
S. pharmaceutical compliance requirements and industry expectations, including the Anti-Kickback Statute, False Claims Act, FDA promotional requirements, HCP interactions, patient-support programs, Medical Affairs independence, privacy, and transparency obligations.
Experience translating legal and regulatory requirements into practical policies, controls, training, monitoring, investigations support, remediation, and business processes.
Biosimilars, specialty pharmaceuticals, ophthalmology, oncology, or other complex therapies.
~ Commercial compliance experience involving GPOs, distributors, specialty pharmacies, provider organizations, or other healthcare intermediaries and commercial partners.
~ Experience evaluating compliance risks arising from third-party commercialization arrangements, affiliated entities, joint ventures, or complex operating models.
~ Information barriers, promotional review, preapproval information exchange, compliance analytics, investigations, auditing, or data-informed monitoring.
Ability to conduct risk assessments, evaluate control effectiveness, identify trends, provide constructive challenge, and escalate material concerns.
Demonstrated discretion in handling privileged, confidential, and commercially sensitive information.
In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. Full time
Salary Range*
$Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements.
Reference: WJ-4487_22036521