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
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