Senior 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 assist 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 (LOB) in support of Compliance and overall business objectives. This role will partner directly with the field-based teams and lead the compliance training 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: Lead the compliance training program in accordance with company directives, policies and procedures. Partner with global compliance and LOB to develop, maintain, and ensure appropriate training content, training matrices and training calendars. Deliver appropriate training content and coaching to ensure standards are clearly communicated to employees.  Load content and assign, track, maintain and report on trainings related to company directives, policies and procedures. Conduct follow-up to ensure completion of required training. Provide support for compliance communications program.
• Business Partnership: Develop and oversee trusted partnerships and effective lines of communication across the commercial organization. Serve as a business partner to the US Neurology field-based teams including sales, field reimbursement support and medical science liaisons.  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 lead 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. Partner with the Associate Director, Compliance to recommend follow-up and appropriate action.
• Monitoring and Auditing: Develop and oversee field force auditing and monitoring initiatives to ensure compliance with Lundbeck’s policies and procedures involving speaker programs, advisory boards, sample compliance, and other business activities. Conduct field monitoring, data reviews and audits of key compliance risk areas, in accordance with the US monitoring program. Draft reports and identify appropriate follow-up.  Assist with all auditing and monitoring programs and processes to ensure effectiveness of overall compliance program.
• Risk Management: Develop and 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.
• System Ownership: Serve as system owner for the electronic learning management system (LMS) and compliance program management software.
• Third Party Management: Oversee vendors and third-party RFP processes. 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.
• 5+ years of Compliance-related experience in the pharmaceutical, biotech, medical device or healthcare industry.
• Understanding of FDA rules and regulations and Fraud and Abuse Laws, such as the Anti-Kickback Statute and the False Claims Act.
• Ability to communicate effectively with individuals at all levels, internally and externally.
• Experience in development of training and curriculum design, including delivery and implementation of training and workshops.
• 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 Excel, Word, and PowerPoint; Internet, or other systems tracking software
• 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.
• 3+ years experience with buy-and-bill systems and reimbursement support programs
• Hands on experience supporting a learning management system (Success Factors experience a plus).
• Experience administering live web meetings and training sessions with WebEX, GoToMeeting/GoToWebinar, Lync, or other webinar software.
• Experience writing quality system documents in a Document Management system (such as Documentum and QDMS).
• Product or sales management experience.
• 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: $115,000 - $145,000 and eligibility for a 15% bonus target based on company and individual performance and eligibility to participate in the company’s long-term incentive plan. 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-LM1, #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.