The primary responsibilities of the Associate Director, Compliance Business Partner I, include:
- To assist in the development, implementation, and continuous improvement of an effective compliance program for all business activities within the Medicine Business Unit;
- To support the risk assessment and analysis process to continuously evaluate risk areas and priorities to guide new Compliance efforts.
- To act as a business partner to the Medicine Business Unit to provide assistance and advice on daily operations and ensure appropriate compliance controls and training, as well as investigations of non-compliant activity and corrective action for identified business activities.
- To work closely with other teams within the Ethics and Compliance Department to ensure consistent application and implementation of identified compliance controls, training, monitoring, and auditing.
- In particular, this position will provide compliance business partner support for Scientific Communications (Independent Medical Education, Scientific Advancement Grants, External Collaborative Research, Investigator Initiated Studies and Publications), Patient Advocacy (including Funding Review Committee), Charitable Contributions, medical monitoring remediation activities for related areas, and the Clinical Development Medical Affairs Department for Oncology.
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:
- Participates in strategic planning for applicable organizational activities with the goal of providing compliance expertise and advice to ensure planning is efficient and considers compliance issues up-front. Also provides day-to-day support, advice and problem-solving expertise to applicable businesses to ensure business operations are conducted in full compliance with all relevant policies and procedures. Develops resources for applicable business areas, as needed, to help meet their respective compliance business needs. Monitors the external environment and recommends improvements to the company's compliance program based on identified industry best practices.
- Serve as a “single point of accountability” for assigned Medicine business partners and provide compliance expertise and guidance, including the business acumen necessary to develop alternative solutions to achieve business objectives and enable decision-making that stays within ethical boundaries while still optimizing business performance. This includes participating in business partner initiatives and programs, attending relevant business and departmental meetings, answering ad hoc compliance questions, and advising on health care provider engagements, etc.
- Acts as a liaison with BI GmbH business and compliance colleagues to influence the conduct of global activities that implicate US laws and regulations.
- Assesses training needs for assigned Medicine business partners, provides input into training plans, and collaborates with appropriate individuals to develop training content, acting as subject matter expert for business area. Facilitates and delivers training as appropriate. Educates business groups in a way that closes knowledge gaps and addresses larger trends.
- 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 the Medicine and Innovation Unit compliance team, 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.
- Collaborate with internal Ethics and Compliance Department team members to identify areas of compliance risk in respective business areas, including but not limited to topics related to the principles of scientific exchange and promotion, health care provider engagements, Transparency & Disclosure, CIA, Anti-Bribery and Anti-Corruption (ABAC), and ensure that systems, policies, procedures, training and other resources are coordinated to mitigate risk to impacted business areas. Effectively communicate and collaborate with Ethics and Compliance Department team members to ensure business and compliance objectives are met. Assist business in remediating findings from investigations, audits, monitoring and other compliance assessments, keep applicable Ethics and Compliance Department members apprised of relevant information from investigation review committees, CAPAs, and day to day business issues that impact compliance initiatives.
- Results oriented; demonstrates strong business partnering skills, flexibility and accountability in helping to find and implement ethical and compliant solutions to new and complex challenges.
- Bachelor’s degree is required.
- One (1) to three (3) years’ experience leading employees and projects.
- Minimum of five (5) years Pharma and/or related experience.
Desired Experience, Skills & Abilities:
Minimum of five (5) years Pharma experience, including experience in at least two of the following areas:
- Medical or R&D Compliance (Medical/Research/Development)
- Scientific Communications (Independent Medical Education, Scientific Advancement Grants, External Collaborative Research, Investigator Initiated Studies and Publications)
- Patient Advocacy (Including Funding Review Committee)
- Charitable Contributions
o Medical monitoring remediation activities
- Clinical Development Medical Affairs Department for Oncology
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers.