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Lundbeck · 1 day ago

Manager, Field Compliance

Deerfield, IL

Full-time

Hybrid

Mid Level

$115K/yr - $135K/yr

3+ years exp

Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. The Manager, Field Compliance will support the Director, Field Compliance and Investigations by driving and implementing the US Compliance Program, partnering with field-based teams, and conducting internal compliance investigations.

Health CareHealth DiagnosticsMedical

Hiring Manager

Laurie Meninno

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

Partner with stakeholders and the Director, Field Compliance and Investigations to assist with reviews, development and updating of field-based directives, policies, and procedures

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

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

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 multiple sources, integrating HR and investigation files, and developing clear analytical summaries and visual presentations for review by the Compliance Committee and Executive Leadership Team

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

Conduct field monitoring, data reviews and audits of key compliance risk areas, in accordance with the US monitoring and auditing program

Serve as system support specialist for the compliance program management software, as needed

Work with Director, Field Compliance and Investigations to help manage relevant vendor relationships

Provide support to track vendor budgets, facilitate the execution of vendor contracts and process invoices, as needed

Proactively provide day-to-day guidance to relevant business units and stakeholders on compliance matters

Help drive a compliant culture

Execute other duties as assigned by Director, Field Compliance and Investigations and Chief Compliance Officer

Stay abreast of relevant laws and regulations and assist with performing industry benchmarking in association with Compliance program oversight

Qualification

Compliance-related experienceFDA rulesRegulationsAnalytical skillsMicrosoft Office proficiencyProject managementCommunicationInterpersonal skillsProblem-solving abilityAttention to detailTime management

Required

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

Preferred

Strong Preference to be based in Deerfield, IL Office

3+ years Compliance-related experience in in the life sciences, pharmaceutical, biotech or medical device industry. This may include consulting experience or in-house experience

Experience writing and editing documents in a Document Management system

Experience conducting investigations of alleged misconduct and compliance policy violations

Experience collecting and analyzing data, including the collection and review of large data sets

Project management experience

Advanced Excel skills