The Associate Director, Compliance will possess working knowledge of AbbVie’s business, the current compliance environment, and the broader business impact of compliance issues to develop and provide solution-oriented compliance guidance related to AbbVie’s compliance program for the company’s Market Access Area. The Associate Director will also provide direct oversight for moderate to complex elements of AbbVie’s compliance program at the business unit, functional or corporate level to address compliance needs and training of Market Access leadership across multiple therapeutic-area aligned inhouse and field-based teams and activities, including National and Regional Account Contracting with health plans/PBMs, Group Purchasing Organizations (GPOs), Supply Chain and Trade, Reimbursement and Pricing and Population Health. In addition, the Associate Director will also work with Medical Affairs to coordinate and provide compliance guidance for the Medical Outcome Science Liaisons who provide clinical resources to Market Access stakeholders.
The Associate Director, Compliance may perform the following with limited supervision from the Compliance
Director, Market Access:
Partners with all levels of key business functions to provide moderate to complex OEC (Office of Ethics & Compliance) and functional policy interpretation and provide guidance on the requirements.
Conducts compliance risk assessments, trend analysis and provides recommendations for compliant business activities.
Conducts moderate to complex policy and procedure reviews and updates related to OEC policy and functional procedures ensuring clarity, applicability, and compliance.
Develops, delivers and updates OEC’ s comprehensive training program on moderate to complex OEC and functional policies and procedures, including the Operating Procedures for Program Funding and AbbVie's Code of Business Conduct, as well as the current compliance environment and compliance issues specific to Market Access contracting, pricing, access, reimbursement and pre-approval messaging to payers and health care decisions makers, including, but not limited to FDA Guidance.
Develops, implements, modifies, and oversees corporate and/or functional monitoring plans and any corrective actions to ensure compliance with policies and procedures.
Assists OEC Director/ECO on compliance audits, when necessary, such as overseeing the fulfillment of auditors’ requests and acting as a liaison between the business and auditors during on site activities. Expected to evaluate and help respond to moderate to complex preliminary audit findings and recommendations, and to guide the business in preparing corrective action(s) to address moderate to complex findings and recommendations, and work with the business to ensure timely completion.
Provides guidance on proposed business strategies and programs, identifies moderate to complex legal and regulatory issues, analyzes alternatives and works with legal and other functions, as appropriate, to propose solutions to the business.
Possesses solid working knowledge of AbbVie’s business, the current compliance environment, and the broader business impact.
Participates in and may lead moderate to complex cross-functional OEC programs.
Required Qualifications:
BA/BS required. CPA, Master's, JD, or equivalent work experience preferred.
Minimum of 5 years' experience with, or exposure to, business functions such as compliance, legal, market access/managed markets, regulatory affairs, government affairs, and finance.
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
Learns, fast, grasps the 'essence' and can change the course quickly where indicated.
Raises the bar and is never satisfied with the status quo.
LI-Remote
Chicago, IL
AbbVie Inc. discovers, develops, manufactures, and sells pharmaceutical products in the United States, Japan, Germany, Canada, Italy, Spain, the Netherlands, the United Kingdom, Brazil, and internationally. The company offers HUMIRA, a therapy administered as an injection for autoimmune and intestinal Behçet's diseases; IMBRUVICA to treat adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma, waldenström’s macroglobulinemia, marginal zone lymphoma, and chronic graft versus host disease; VENCLEXTA, a BCL-2 inhibitor used to treat adults with CLL or SLL; VIEKIRA PAK, an interferon-free therapy to treat adults with genotype 1 chronic hepatitis C virus (HCV); TECHNIVIE to treat adults with genotype 4 HCV infection; and MAVYRET to treat patients with chronic HCV genotype 1-6 infection.
It also provides KALETRA, an anti-human immunodeficiency virus (HIV)-1 medicine used with other anti-HIV-1 medications to maintain viral suppression in HIV-1 patients; NORVIR, a protease inhibitor indicated in combination with other antiretroviral agents to treat HIV-1; and SYNAGIS to prevent respiratory syncytial virus infection at-risk infants. In addition, the company offers AndroGel, a testosterone replacement therapy for males; CREON, a pancreatic enzyme therapy for exocrine pancreatic insufficiency; Synthroid to treat hypothyroidism; and Lupron to treat prostate cancer, endometriosis, and central precocious puberty, as well as anemia.
Further, it provides Duopa and Duodopa, a levodopa-carbidopa intestinal gel to treat Parkinson’s disease; Sevoflurane, an anesthesia product; and ORILISSA, a non-peptide small molecule gonadotropin-releasing hormone antagonist for women with moderate to severe endometriosis pain. It has collaborations with Alector, Inc.; Janssen Biotech, Inc.; Galapagos; Bristol-Myers Squibb Company; and Calico Life Sciences LLC. The company was incorporated in 2012 and is headquartered in North Chicago, Illinois.