Sr Manager Compliance Programs - 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.  Preference for individual to be based in Deerfield, IL

SUMMARY:

 This role will report directly to the Director, Compliance (“Director”) and 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 focus on dedicated, strategic partnership with the home office and work closely with key stakeholders and partner with all lines of business (LOB) in support of organizational Compliance and overall business. Specifically, this role will be responsible for developing, implementing, and executing the Compliance training and communications program, as well as developing and updating healthcare policies, procedures and controls.

ESSENTIAL FUNCTIONS:

• Business Partnership: Serve as a business partner to designated business units across Lundbeck.  Proactively provide guidance and support to all stakeholders across the organization on compliance matters. Develop trusted partnerships and effective lines of communication across the company.  Participate in cross-functional initiatives.  Help drive a compliant culture.
• Policies, Procedures and Controls, including Code of Conduct:  In partnership with the Director, develop and update policies, procedures and standards of conduct. Responsible for the drafting, implementation and communication of policies and procedures.  Partner with stakeholders to assess the need for and assist with periodic reviews of directives, policies and procedures.
• Training, Education and Communications:  In alignment with compliance objectives and Compliance program strategy, responsible for leading the Compliance training, education and communications program. Develop, implement and execute all aspects of the compliance training program. Partner with the Compliance Team and business units to ensure appropriate and effective training and education across the organization.  Assist with the development and delivery of appropriate trainings mapped to key risk areas.  Responsible for leading the compliance communications program including the development of content and ensuring timely delivery of newsletters and compliance updates utilizing all available communication channels.
• Project Management:  Identify and lead strategic projects designed to fulfill the needs of and enhance the effectiveness of the Lundbeck Compliance Program. Drive results-oriented process improvement.
• Risk Management: Support the Director in developing and implementing risk mitigation and enhancement plans; and (2) developing risk assessment protocols for ongoing review.
• Investigations:  Assist with internal compliance investigations ensuring legal compliance and managing risk. Assist with escalations as needed.  Enforce standards and ensure appropriate follow up action.
• Monitoring and Auditing:  Implement effective auditing and monitoring programs and processes to ensure effectiveness of overall compliance program inclusive of policies and procedures, trainings, investigations, and other compliance initiatives. 
• Third Party Management: Work with the Director to oversee vendors and third-party RFP processes.  This includes managing budget, reviewing, and verifying contract terms with Legal, reviewing invoices, and processing timely payment.
• Other Duties: Assist the Director and CCO with the preparation of reports, summaries and documentation for internal and/or external use and other duties as assigned.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

• Accredited Bachelor’s degree.
• 5+ years of Compliance-related experience in the pharmaceutical, biotech, medical device or healthcare industry or at an agency or consultancy supporting any of these industries.
• Understanding of FDA rules and regulations and Fraud and Abuse Laws, such as the Anti-Kickback Statute and the False Claims Act..
• Strategic mindset and results-oriented problem-solving skills.
• Ability to communicate effectively with individuals at all levels, internally and externally.
• Demonstrated experience managing projects and working with multi-functional teams.
• Proven skillset as a stro