Director, Compliance

Description:  To lead the development, implementation, and continuous improvement of an effective compliance program for all business activities within the Medicine & Innovation Unit (IU) functions. To support the risk assessment and analysis process to continuously evaluate risk areas and priorities to guide new compliance efforts.  To lead business partner efforts in Medicine & IU and to provide assistance and advice on daily operations and ensure appropriate compliance controls, training, and remediation of findings associated with A&M activities for identified business activities.  To work and collaborate effectively with other teams within the Ethics and Compliance Department.   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 a number of 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.   Duties & Responsibilities: Develops, implements and manages compliance systems and tools for Medicine & IU including: drafting and communicating policies; developing and implementing compliance training; corrective action, and reporting to senior management on compliance issues.   Assesses training needs for business groups, develops training plans, and collaborates with appropriate individuals to develop training content, acting as subject matter expert for business area. Leads and provides direction to team of Compliance professionals providing business partner support within the Medicine & IU functions.  Maintains overall responsibility for advice and consistency across all Medicine & IU functions.   Provides advice and proposed solutions on ethics and compliance matters relating to Medicine & IU, and on a wide-range of issues impacting those groups, to senior leaders within Medicine & IU, both in the U.S. and globally.  Recommends and ensures completion of CAPAs resulting from monitoring of key business activities within Medicine & IU, including providing regular reports as needed on trended monitoring findings to appropriate Compliance and business leadership, identifies areas of training opportunity based on monitoring findings, leads the development and implementation of this training. Provides input into annual auditing plan for business activities, driven by a risk-based analysis and prioritization and in collaboration with applicable department leaders.  Collaborates with personnel responsible for auditing plans to execute the auditing plan, including developing and executing action plans for identified CAPAs (Corrective and Preventative Actions) and monitoring established controls after implementation.  Analyzes auditing results to recommend improvements in Compliance or business operations.  Supports other activities of Medicine & IU Compliance Department, including risk assessment and strategic planning, training and communication, health care provider interaction initiatives (i.e., implementation of fair market value, Sunshine Act requirements), and development of ethical business culture. To the extent applicable, lead (recruit, hire, coach, develop, motivate, manage and monitor performance) and directly manage a staff of dedicated compliance managers and/or professionals.  Creates and maintains a performance-based culture with clear accountability and a sense of urgency for achieving results.  Management includes recommending goals, performance evaluations and input into compensation decisions.  In particular, this position will provide lead compliance business partner support for the IU (which includes the Research & Development Business Units) as well as the Clinical Development Medical Affairs Respiratory Department within the Medicine Business unit. Requirements: Bachelors' degree in Business Administration is required. Strong history of prior compliance experience in a US based company, including six (6) to ten (10) years or similar experience with the branded pharmaceutical business and/or related function; previous regulatory or pharmaceutical compliance experience preferred.  Strong interpersonal and management skills and experience.  Demonstrated ability to critically analyze and assess business and regulatory information and effectively communicate up, down and across the organization.  One (1) to three (3) y ears leadership experience and results orientation. Proven ability to lead and influence diverse groups.  History of successful performance.  Desired Experience, Skills & Abilities: Prior experience in the following areas: Medical or R & D Compliance ( Medical/Research/Development) Compliance business partner experience for Clinical Development or Medical Affairs Strong Project Leadership/Management Experience   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 1813425
Salary Range: NA
Minimum Qualification
5 - 7 years

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