San Simeon, California
San Simeon, California
Saint Paul, Minnesota
Des Moines, Iowa
Bloomington, Indiana
Ames, Iowa
Brookline, Massachusetts
Fort Worth, Texas
Boston, Massachusetts
Posted: 12-May-23
Location: Ridgefield, Connecticut
Type: Full Time
Categories:
Required Education:
Internal Number: 235486
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
As the Executive Director (ED) of Compliance Operations, you will be the key leader in the compliance operations area for our US compliance team at Boehringer Ingelheim (www.Boeheringer-ingelheim.com). This individual will be responsible for leading and providing the overall strategic direction to the Compliance Operations department for all Boehringer Ingelheim entities in the U.S. to ensure a data-led, risk-based Compliance Program.
The ED leads and coordinate the companies' efforts to comply with laws and obligations that govern its Compliance Program. The incumbent will manage and develop a team of compliance professionals responsible for developing, implementing and maintaining a highly effective Compliance Program, including optimizing applicable policies & procedures, Training/Communications, Auditing & Monitoring, Risk-Assessment, corrective and preventative actions (CAPAs), Transparency, Disclosure & Government Reporting (T&D),Anti-Bribery, Anti-Corruption program (ABAC), FMV evaluations, Healthcare Compliance (HCC) manager for cross-border engagements, the BI global center of excellence for cross-border spend reporting, and Compliance Analytics.
This role is responsible for ensuring the program is continuously improved based on analyzing newly published CIAs and other enforcement actions and industry guidance, regulations and best practices. This position entails working collaboratively with and influences through organizational credibility, the Commercial, Medicine/IU, Animal Health, Biopharmaceutics and Corporate/global Compliance professionals within BI to ensure coordinated Compliance direction.
Duties & Responsibilities:
- Directs, implements, documents, and maintains coordinated Compliance Program that meets the expectations of Federal and State regulators and Company policy.
- Coordinates resources to ensure the ongoing effectiveness of BI’s U.S. Compliance Program.
- Directs all program elements common across all U.S. business entities, including developing and implementing Compliance systems and tools.
- Drafts, communicates and maintains policies and procedures.
- Develops and oversees implementation of the U.S. Compliance Training Program.
- Oversees all transparency & disclosure (T&D) data capture and government reporting obligations (local and cross-border), including without limitation, Federal Open Payment and state reporting requirements.
- Oversees Company Auditing, Monitoring and Risk-Assessment program (AMRA), including overseeing corrective actions; evolves and maintains the Compliance analytics program and platforms.
- Oversees the US-wide ABAC and FMV program; and reports to senior management on Compliance issues.
- Defines and directs reporting on key performance indicators.
- Prepares and delivers communications to the Board, BIPI Compliance Advisory Council, U.S. Compliance Committee (CMC) and other senior executives.
- Coordinates with Legal, HR, IT, and other departments to ensure effective management of cross-department compliance controls, including overseeing internal and third-party audits, etc.
- Develops and/or oversees Compliance Training Program and monitoring strategies and systems.
- Influences and coordinates commercial, Medicine & IU training, auditing/monitoring and Compliance Operations’ needs (e.g., third-party screening, ABAC, FMV (Fee for service and engagements with customer organizations, etc.)
- Designs and implements transparency and disclosure (T&D) strategy for complying with all legal requirements for spend disclosure, including without limitation, Federal Open Payment (Sunshine) laws, as well as State and City-level compliance requirements.
- Develops, implements, and monitors local and cross border disclosure program and influences and advises on global disclosure program.
- Leads the assessment of and implements controls for cross-functional compliance risks, including anticorruption.
- Supports compliance coordinators on trade, anti-discrimination, insider trading, records management and antitrust risks and activities.
- As HCC Manager communicates all corporate compliance requirements within US, Reviews, routes though applicable approval processes, maintains databases for all cross-border engagements with US HCPs, HCOs, Patients and Patient Organizations.
- Designs and implements the US-wide compliance auditing, monitoring, and risk-assessment program designed to prevent, detect, and respond appropriately to compliance risks.
- Designs, implements and enhances Compliance analytics functionality, including risk-assessment, tracking and quantifying risks and effectively/efficiently deploying and triaging resources to identify, quantify and mitigate company risks.
- Oversees selection of all U.S.-wide auditing and monitoring target identification and activities.
- Leads (recruit, hire, coach, develop, motivate, manage and monitor performance) and directly manages a staff of dedicated Compliance professionals.
- Creates and maintains a performance-based team culture with clear accountability and a sense of accountability for achieving results.
- Management includes goal setting, performance evaluations and compensation decisions, hiring, and coordinating with stakeholders on the performance and expectations of the groups.
Requirements:
- Bachelor’s degree from an accredited institution required with a focus in Business Administration preferred; Master’s degree (e.g., MBA, MSc) and/or Doctoral degree (e.g., PhD or LLM) in Law preferred.
- Expertise and experience in pharmaceutical Compliance Operations, including T&D, ABAC, FMV, process and system implementation for government reporting, compliance data-capture and spend-reporting systems.
- Minimum of ten to fifteen (10-15) years of experience in Compliance with a significant leadership role designing/overseeing an Auditing or Monitoring Program within a U.S. pharmaceutical Compliance (or similar) function.
- Leads teams and projects of material risk/scope/complexity with minimal supervision, with at least six to ten (6-10) years of leadership experience, including demonstrated experience leading teams / managing groups (with strong preference for experience of managing groups or projects of significant risk, scale or complexity.
- Significant experience designing, leading and managing an Auditing/Monitoring Program in a pharmaceutical environment is necessary as is prior experience overseeing a risk-assessment programs.
- Requires a strong healthcare compliance background.
- Requires a clear understanding of the elements of an effective Compliance Program.
- Requires a clear understanding of applicable laws and regulations, enforcement actions and evolving best practices relevant to an Ethics & Compliance function in a pharmaceutical company.
- Must be able to work independently to resolve issues and demonstrate excellent professional judgment.
- Demonstrated ability to work collaboratively with others, the agility to rapidly adapt to changing conditions and the ability to drive accountability and results are required.
- Prior experience working under a CIA, DPA or Consent Decree is highly preferred, as is experience with data visualization and analytics software.
- Knowledge and demonstrated experience in data analytics is required.
- Knowledge and demonstrated experience in training (both in terms of training strategy and training operations).
- Substantial business, legal and regulatory knowledge and experience in pharmaceutical industry.
- Strong interpersonal, management and influencing skills and experience.
- Strong results-orientation.
- Proven ability to lead and influence outside scope of authority.
- History of successful performance in pharmaceutical compliance leadership role.
- Strong history of prior compliance, healthcare, and/or legal leadership and experience in the US, with focus on Compliance Operations (FMV, ABAC, third-party due diligence, system validation, T&D, government reporting, computer system validation etc.), strong experience setting up and leading Auditing, Monitoring and Risk-Assessment programs using modern/data-led programs and demonstrated experience in compliance analytics.
- Understanding of international compliance requirements on US operations.
- Industry certification (e.g., HCCA or SCCE) preferred.
Eligibility Requirements:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
