At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.
The Compliance Analyst will assist with the implementation of all elements of the Lundbeck North America 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.
Policies, Procedures and Controls, including Code of Conduct: Responsible for supporting the ongoing maintenance and updates to steering documents, policies and procedures. Partners with LOB to assist with reviews, development and updating of directives, policies and procedures.
Training, Education and Communications: Support the implementation of the compliance training program in accordance with company directives, policies and procedures. Provide support for compliance communications program.
Investigations: Provide support for internal investigations relating to alleged compliance violations, as needed.
Monitoring and Auditing: Provide support for auditing and monitoring initiatives to ensure compliance with Lundbeck’s policies and procedures. Assist with reviews and audits of key compliance risk areas, in accordance with the US monitoring program. Assist with auditing and monitoring programs and processes to ensure effectiveness of overall compliance program.
Assessments: Provide support for the development and implementation of assessments to determine effectiveness of Compliance trainings, education and other initiatives.
Compliance Program Projects and Workstreams: Provide support for all projects and workstreams in support of the Compliance Program.
System Support: Serve as system support specialist for the electronic learning management system (LMS), compliance program management software, and electronic steering document management system (LuDo).
Third Party Management: 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 on compliance matters. Help drive a compliant culture. Execute other duties as assigned by the Senior Manager, Compliance and Chief Compliance Officer.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- Accredited Bachelor’s degree.
- 2+ years of Compliance-related experience in the pharmaceutical, biotech or medical device industry or 2+ years of Compliance-related experience working for a vendor supporting the pharmaceutical, biotech or medical device 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.
- 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.
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- 2+ years Compliance-related experience in the pharmaceutical industry.
- Experience writing quality system documents in a Document Management system (such as Documentum and QDMS).
- Project management experience.
- Advanced Excel skills.
- Willingness/Ability to travel up to 15% domestically. International travel may be required.
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.
Compliance Officer / Analyst