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Manager, Compliance

 
Requisition ID:  802
Location: 

Deerfield, Illinois, US

Date: 
 

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 pharmaceutical 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.

SUMMARY  

The Compliance Manager will have direct responsibility for and 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.   

 
 

ESSENTIAL FUNCTIONS:   

  • Policies, Procedures and Controls, including Code of Conduct: Responsible for 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:  Lead the compliance training program in accordance with company directives, policies and procedures. Partners 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.   
  • Investigations: Conduct internal investigations relating to alleged compliance violations. Effectively manage all aspects of internal investigations, while ensuring legal compliance and managing risk. Partner with the Chief Compliance Officer (CCO) 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.  
  • Assessments: Conduct assessments to determine effectiveness of Compliance trainings, education and other initiatives.    
  • System Ownership: Serve as system owner for the electronic learning management system (LMS), compliance program management software, and electronic steering document management system (LuDo).  
  • Third Party Management: Manage day to day vendor interactions including budget, SOWs, verifying vendor invoices, and processing for timely payment.  
  • 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 CCO.  

 
 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:  

  • Accredited Bachelor’s degree.  
  • 3+ years of Compliance-related experience in 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.  
  • 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.  

 
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 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 employement 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. 

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. 

An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.
Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.