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:
The Associate Director, Field Compliance role will have direct responsibility for and assist with driving and implementing all elements of the Lundbeck Compliance Program, which are modeled after the seven elements of an effective compliance program. This role will focus on: (1) dedicated, strategic partnership with the business unit field-based teams, including sales, field access and medical science liaisons; and (2) developing, leading, managing and executing all field-based training and communications plans. This role will develop and implement Lundbeck’s field compliance risk mitigation strategy, work with commercial and medical leadership to continually identify and mitigate compliance risks and work closely with key stakeholders and partner with lines of business (LOB) in support of field-based compliance and overall business objectives across the entire business unit brand portfolio.
ESSENTIAL FUNCTIONS:
- People Management. Manage matrix relationships with stakeholders across the entire organization to provide compliance guidance and drive an ethical and compliant culture in support of business objectives. Provide direction and feedback to other members of the Compliance team in relation to field compliance.
- Field Compliance Oversight: Identify and lead strategic projects designed to ensure field compliance with policies and procedures. Responsible for strategy, trend and gap analysis, programs, policies, monitoring, training and corrective actions in support of promotional and medical compliance for the field.
- Field Risk Mitigation & Strategy: Develop, lead and execute field compliance risk mitigation strategy including ongoing risk assessments, gap and trend analysis and results-oriented risk mitigation plans in support of field compliance and to determine effectiveness of Compliance trainings, education and other initiatives.
- Dedicated Business Partnership: Develop and maintain trusted partnerships and effective lines of communication across the business unit commercial and medical organizations. Serve as a dedicated business partner to the field, including senior leadership. Proactively provide guidance and support to all business unit commercial and medical stakeholders across the organization on compliance matters. Participate in cross-functional initiatives and meetings. Lead and manage Compliance Advisory Council.
- Training, Education and Communications: Develop, lead, manage and execute the field compliance training and communications program in accordance with company directives, policies and procedures. Partner with US and global compliance, LOB and the commercial and medical organizations to develop, maintain, and ensure appropriate training and communications content, training matrices and training calendars. Deliver appropriate training content and coaching to ensure standards are clearly communicated to employees. Align field compliance communications program with overall compliance communications program.
- Policies, Procedures and Controls, including Code of Conduct: Responsible for ongoing maintenance and updates to field-based steering documents, policies and procedures. Partner with LOB to assist with reviews, development and updating of directives, policies and procedures.
- Investigations: Support and conduct internal investigations relating to alleged compliance violations, while ensuring legal compliance and managing risk. Partner with the CCO and Director, Field Compliance & Investigations to recommend follow-up and appropriate corrective action. Perform gap and trend analysis to develop risk mitigation strategies.
- PHI Disposal Process: Own, manage and execute protected health information (PHI) disposal process and conduct investigations in support. Conduct ongoing trend analysis to determine gaps or additional training needs.
- Monitoring and Auditing: Develop and oversee field-based auditing and monitoring plans to ensure compliance with Lundbeck’s policies and procedures. Conduct field monitoring, data reviews and audits of key compliance risk areas, in accordance with the US monitoring program. Work with other departments to perform additional auditing related to healthcare compliance. Monitor field-based communications (commercial and medical), sponsorships, HCP exhibits, ad boards, conferences, HCP engagements, and FMV analysis and conduct related investigations. Draft reports and identify appropriate follow-up and risk mitigation initiatives. Assist with all auditing and monitoring programs and processes to ensure effectiveness of overall compliance program. Update data dashboards in support of predictive analytics and risk management initiatives.
- System Ownership: Serve as system owner for compliance program management software.
- Third Party Management: Oversee vendors and third-party RFP processes. This includes reviewing vendor effectiveness, managing vendor relationships and performance reviews, identifying and evaluating new vendors as needed, managing budget, reviewing and verifying contract terms with Legal, reviewing invoices, and processing timely payment.
- Advice, Guidance and Other Duties: Drive a compliant culture. Stay abreast of relevant laws and regulations and perform industry benchmarking as to Compliance oversight program. Proactively provide day-to-day guidance to business unit commercial and medical field-based teams on compliance matters. Implement and execute all obligations in support of government investigations and agreements, as assigned by CCO. Provide support to US compliance and global compliance, as needed. Assist the CCO with the preparation of reports, summaries and documentation for internal and/or external use. Execute other duties as assigned by the CCO.
REQUIRED EDUCATION, EXPERIENCE, and SKILLS:
- Accredited bachelor’sdegree.
- 8+ years of Compliance-related experience in the life sciences, pharmaceutical, biotech or medical device industry. This may include consulting experience or in-house experience.
- 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.
- Ability to communicate effectively with individuals at all levels, internally and externally.
- Demonstrated experience managing projects and working with multi-functional teams.
- Experience in development of training and curriculum design, including delivery and implementation of training and workshops.
- 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.
- Strong attention to detail.
- Ability to function in a fast-paced environment handling multiple tasks simultaneously.
- Demonstrated proficiency with AI tools and Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software.
- Experience administering live web meetings and training sessions with Zoom, Microsoft Teams, Webex, GoToMeeting/GoToWebinar, Lync, or other webinar software.
PREFERRED EDUCATION, EXPERIENCE, and SKILLS:
- 8+ years Compliance-related experience in the pharmaceutical or medical device industry.
- Hands on experience supporting a learning management system and/or compliance program management software.
- Experience building and performing analysis using data dashboards.
- Experience drafting and updating policies and SOPs.
- Product, marketing, or sales management experience.
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: $165,000 - $195,000 and eligibility for a 20% 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 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.
