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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 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.
Risk Management: 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.
Monitoring and Auditing: 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.
System Support: Serve as system support specialist for the compliance program management software, as needed.
Third Party Management: 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.
Advice, Guidance and Other Duties: 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.
Required Education, Experience, and Skills: 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 Education, Experience, and Skills: 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.
Travel: Willingness/Ability to travel up to 30% domestically. International travel may be required. If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $115,000 - $135,000 and eligibility for a 10% bonus target based on company and individual performance. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our career site . Applications accepted on an ongoing basis . ,
Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site .
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site .
Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify .
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