Manager, Field Compliance

Manager, Field Compliance at Lundbeck summary:

Manager, Field Compliance partners with US Psychiatry field-based teams to implement and monitor Lundbeck’s compliance program, focusing on training, policies, risk mitigation, auditing, and investigations. The role conducts internal investigations, data analysis and visualization, and provides coaching and system/vendor support to ensure adherence to healthcare regulations and company policies. Requires 3+ years healthcare compliance experience, knowledge of FDA/PhRMA/Anti-Kickback/FCA, advanced Excel and travel up to 30%.

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

Remote/Commuter Opportunity - Open to candidates within the United States

Summary:

The Manager, Field Compliance will support the Director, Field Compliance and Investigations with driving and implementing all elements of the Lundbeck US Compliance Program, which are modeled after the seven elements of an effective compliance program. This role will work closely with key stakeholders and partner with lines of business to focus on: (1) dedicated, strategic compliance partnership with field-based teams, including sales and medical science liaisons;

and (2) the support and remediation of internal compliance investigations. This role will partner directly with the US Psychiatry field-based teams, assist with field-based investigations, deliver field-based coaching and consultation, and conduct auditing and monitoring of field-based activities in support of the compliance program.

Essential Functions:

• Dedicated Business Partnership: 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.
• Policies, Procedures and Controls, including Code of Conduct: 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. Partner with stakeholders and the Director, Field Compliance and Investigations to assist with reviews, development and updating of field-based directives, policies, and procedures.
• Training, Education and Communications: Assist with the implementation of the compliance training program in accordance with company directives, policies, and procedures. Partner with the Compliance team and the business to ensure appropriate and effective training and education for the US Psychiatry field-based teams. Deliver appropriate training content and coaching to ensure standards are clearly communicated to employees. Provide support for compliance communications program.
• Field Compliance Risk Mitigation: Identify and implement strategic projects designed to ensure field compliance with policies and procedures. Provide support for strategy, trend analysis, programs, policies, monitoring, training, and corrective actions in support of promotional compliance and medical science liaison compliance for the field.
• Investigations: Conduct and/or provide support for internal investigations relating to alleged compliance violations. With supervision, effectively manage all aspects of internal investigations, while ensuring legal compliance and managing risk. Partner with the Director, Field Compliance and Investigations to recommend and provide follow-up and appropriate corrective action. Support investigation audit reporting by extracting and consolidating data from…