Compliance Manager - Remote Opportunity

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? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!

Remote opportunity - Open to candidates anywhere in the greater United States

SUMMARY:

This role will have direct responsibility for and assists with the implementation of 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 (LOB) in support of Compliance and overall business objectives. This role will partner directly with the field-based teams, perform field-based investigations, and conduct auditing and monitoring in support of the compliance program.

ESSENTIAL FUNCTIONS:

• Policies, Procedures and Controls, including Code of Conduct: Responsible for ongoing maintenance and updates to steering documents, policies, and procedures. Partner with LOB to assist with reviews, development and updating of directives, policies, and procedures.
• Training, Education and Communications: Implement the compliance training program in accordance with company directives, policies, and procedures. Partner with the Compliance team and LOB to ensure appropriate and effective training and education across the organization. Deliver appropriate training content and coaching to ensure standards are clearly communicated to employees. Provide support for compliance communications program.
• Business Partnership: Develop and implement trusted partnerships and effective lines of communication across the commercial organization. Serve as a business partner to the US Psychiatry field-based teams.  Proactively provide guidance and support to all commercial stakeholders across the organization on compliance matters. Participate in cross-functional initiatives.
• 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 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 Associate Director, Compliance to recommend follow-up and appropriate action.
• Risk Management: Implement 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 program.
• System Support: Serve as system support specialist for the electronic learning management system(s) (LMS) and compliance program management software, as needed.
• Third Party Management: 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 Associate Director, Compliance and Chief Compliance Officer.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

• Accredited Bachelor’s degree.
• 3+ years of Compliance-related experience in the healthcare industry.
• Understanding of FDA rules and regulations 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.
• The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• 3+ years Compliance-related experience in the pharmaceutical industry.
• 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 20% domestically. International travel may be required.

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: $90,000 - $115,000 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 site.  

#LI-M1, #LI-Remote

Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? 

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 and is an affirmative action employer. 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.