Senior 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? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

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

SUMMARY:

This role will report directly to the Director, Compliance Programs 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 and 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. Conduct ongoing evaluations of monitoring and auditing outcomes, along with updates in laws, regulations, and industry standards (e.g., PhRMA Code), to proactively ensure policies and controls remain current and effective.
• 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.Lead 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: In partnership with the Director, 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 budgets, reviewing, and verifying contract terms with Legal, reviewing invoices, and processing timely payments.
• 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.
• 6+ years of Compliance-related experience in the pharmaceutical, biotech or medical device industry or in a consulting firm that supports these industries
• Demonstrated knowledge and 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.
• Exceptional writing skills, with the ability to clearly articulate complex concepts and ensure accurate pull-through from policies and procedures.
• 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 strong collaborator, problem solver and business partner.
• Proactive, self-starter with a strong sense of ownership and accountability.
• Demonstrated ability to work effectively in individual and team settings.
• Strong planning, analytical, organizational, and time management skills.
• Keen attention to detail.
• Ability to function in a fast-paced environment handling multiple tasks simultaneously.
• Experience in drafting, reviewing, and editing compliance-related documents and training materials.
• Demonstrated proficiency with Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software.
• Technical aptitude and ability to quickly learn and adapt to new digital communication tools, such as Poppulo, for generating newsletters.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• 6+ years of Compliance-related experience in the pharmaceutical industry.

TRAVEL

• Willingness/Ability to travel up to 15% 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: $135,000 - $165,000 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 career site. Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote

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.