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About the role
- Manager, Field Compliance supporting US Psychiatry compliance program at Lundbeck. Driving and implementing all elements of Lundbeck US Compliance Program along with field-based teams.
Responsibilities
- Serve as a business partner to the US Psychiatry field-based teams
- Proactively provide guidance and support to all commercial and medical stakeholders across the organization on compliance matters
- Participate in cross-functional initiatives
- Develop and implement trusted partnerships and effective lines of communication across the US Psychiatry organization
- Responsible for relevant training and awareness for field teams regarding policies and procedures and the development of one pagers and field resources that are in alignment with Policies, Procedures and Controls, including Code of Conduct
- Assist with the implementation of the compliance training program in accordance with company directives, policies, and procedures
- Identify and implement strategic projects designed to ensure field compliance with policies and procedures
- Conduct and/or provide support for internal investigations relating to alleged compliance violations
- Assist with the implementation of risk mitigation strategy and ongoing risk assessments, risk analysis and results-oriented risk mitigation plans in support of field compliance and to determine effectiveness of Compliance trainings, education, and other initiatives
- Develop, execute, and enhance field-based auditing and monitoring initiatives involving speaker programs, advisory boards, sample compliance, and other business activities, to ensure compliance with Lundbeck’s policies and procedures and effectiveness of overall compliance program
- Perform data-driven analyses, including collecting, synthesizing, and evaluating data sets, and develop clear, actionable visualizations that communicate compliance risks, control gaps, and remediation opportunities to sales leadership and other business stakeholders.
Requirements
- Accredited bachelor’s degree
- 3+ years of Compliance-related experience in the healthcare industry (ie. pharmaceutical, medical device, biologics, healthcare or consulting company that supports one of these industries)
- Knowledge and understanding of FDA rules and regulations, PhRMA Code, and Fraud and Abuse Laws, such as the Anti-Kickback Statute and the False Claims Act
- Excellent communication, presentation, and interpersonal skills along with an ability to influence both within and outside the organization
- Ability to effectively collaborate and problem solve
- Proactive, self-starter with a strong sense of ownership and accountability
- Strong planning, analytical, organizational, and time management skills
- Strong attention to detail
- Ability to function in a fast-paced environment handling multiple tasks simultaneously
- Demonstrated proficiency with Microsoft Office suite, including Teams, Excel, Word, and PowerPoint
- Experience administering live web meetings and training sessions with Zoom, Microsoft Teams, WebEX, GoToMeeting/GoToWebinar, Lync, or other webinar software.
Benefits
- flexible paid time off (PTO)
- health benefits to include Medical, Dental and Vision
- company match 401k
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