Assist with all compliance activities in the US Region and help prepare the organization to execute on the 2030 strategy, providing Compliance generalist and healthcare laws expertise to support the further evolution of the US Compliance program.
Candidates to possess expertise in at least 2 of the following areas:
Policies/Procedures, Training, & Compliance Culture
- Draft and/or update US-wide compliance policies and procedures that ensure compliance with applicable laws, regulations and industry codes and alignment with global policies.
- Draft and/or update appropriate compliance policies and ensure all are up to date and accessible to all employees.
- Develop effective compliance training programs to ensure a thorough understanding and appreciation of the laws and regulations that impact the company's operations and how to conduct business practices, reflecting ethical standards and the latest developments utilizing adult learning tools and strategies.
- Design strategy and oversee Compliance, ethics & integrity communications to support a strong culture of compliance and integrity, including development of materials for Compliance campaigns, internal portals, webpages, newsletters, etc. and promoting awareness of the Compliance SpeakUp hotline.
- Partner with employees and leadership to maintain and further develop a strong culture of compliance throughout the organization, including personal accountability at all levels with a spirit of partnership, trust, and transparency.
Monitoring, Auditing, & Investigations
- Lead the design and processes for data analytics, accessing various data sources (e.g., healthcare professional engagements, grants and donations, sponsorships, and displays and exhibits) or managing outsourcing through vendors.
- Responsible for gathering and analyzing data from a variety of internal and external sources, utilizing organizational software applications or outsourced vendor platforms to identify potentially high-risk activity and other business practices that may pose a compliance risk to the organization. The position requires the ability to collect, analyze, trend and benchmark data from conceptualization through presentation of the data in support of the compliance program.
- Provide expertise regarding aspects of database development, data gathering and analysis.
- Identify and analyze trends, produce statistical reports to support the development of discussions and presentations with Compliance management.
- Collaborate with other members of the Compliance team, both proactively and on an as-needed basis, for project-based and operational activities pertaining to various elements of ethics and compliance program.
- Support compliance monitoring and risk assessment activities and investigations into potential compliance matters as needed in collaboration with compliance colleagues.
- Maintain and strengthen business expertise and nurture cross-functional relationships to enable proactive, holistic, and cross-functional approaches to risk identification and compliance.
- For this role, Bachelor's degree in Healthcare, Business, Computer Science, Statistics or equivalent combination of education and experience is required. Masters Degree in Healthcare, business, or Statistics is preferred. Proficiency with applied statistics and analytical tools, knowledge of data analysis methodology, and data mining
- Further the design and execute healthcare compliance monitoring program activities ( g., field rides, speaker programs, congresses) and records review ( e.g,. travel & expense, healthcare professional engagements).
- Evaluate and identify potential areas of compliance vulnerability and risk.
- Conduct LEO US compliance investigations involving potential violations of compliance policies, laws, or regulations and oversee corrective actions.
- Conduct periodic internal reviews, risk assessments, monitoring and auditing to ensure that compliance policies and procedures function as intended and the company identifies potential compliance risks and remediates where necessary
- Assist in and oversee the implementation of corrective action plans as necessary.
- Develop and maintain dashboards reflecting Compliance risks and monitoring results.
- Assess compliance monitoring tools.
- Partner with relevant departments in executing collaborative monitoring and corrective action activities.
- Execute auditing plans relevant to LEO US business activities.
- Work with Internal Audit to provide input on annual audit plans and work with the business to timely complete corrective action plans
- Prepare and deliver periodic reports and presentations related to investigations and auditing activities.
- Participate in annual risk assessments and the development and execution of risk action plans
- Maintain and strengthen business expertise and nurture cross-functional relationships to enable a proactive, holistic and cross-functional approach to risk identification and compliance
- Additional duties as assigned by LEO Pharma Management
- Complete all company-based and job-related training as assigned by LEO Pharma within the required timeline.
Ready to learn more about LEO Pharma?
- JD or relevant advanced degree preferred.
- 7-10 years of legal, compliance or commercial experience in-house with a pharmaceutical, biotechnology or other life sciences company (experience with biologic products preferred).. Working knowledge of HCP engagement, grants management, spend transparency and other systems utilized in business and compliance operations.
- Industry knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, Anti-kickback Statute, the False Claims Act, Food & Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals and current activities and developments involving pharmaceutical sales and marketing
- Excellent communication and organizational skills
- Team player with demonstrated ability to develop, maintain and grow relationships
- Direct multiple projects simultaneously, honing analytic and project management skills
- Willingness to travel domestically/internationally ( up to 25%post-pandemic)
- Must be able to perform all essential functions of the position, with or without reasonable accommodation.
LEO Pharma has been pioneeringmedical innovationsformore than110 years. Today, LEO Pharmalooks to constantly improve andextend what is possible for the benefit of patients. Our rapidly expandingproduct portfolio andpipeline includesglobal therapeutic areasinpsoriasis,eczema, skininfections,acne,rosacea and, most recently, raredisease.
LEO Pharma believes in challenging the status quo,so we approachdermatology"beyond the skin."Our global innovation ecosystem includes internalresearch and development,digital health viatheLEO Innovation Lab, based in Copenhagen,and the LEO Science & Tech Hub, housed in Cambridge, Mass.
As welook to shapeourU.S. footprint now and in the future, we pride ourselves on ouragileandentrepreneurial environment. It allows passionate people to collaborate and push the boundaries of science in hopes to provide solutions for patients.
We offeracompetitivecompensationpackage, 401k match, vision, dentalandhealth insurance,annualbonus,threeweeks' vacationto start,a culture that emphasizeswork-life balance,bothpaternity and maternity leave,free membership to the on-site gym,bagel Mondaysand-most of all- aFUNand celebratorywork environment.
Let's wrap this up
If you are interested in joining a growing and nimble company,andhelp shape the future of medical dermatology, then send in your resume today!
LEO Pharma, we welcome and consider applications from all qualified candidates because we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions for LEO Pharma and meet the needs of the wonderfully diverse marketplace we operate in.
LEO Pharma Inc. is an Equal Opportunity/Affirmative Action Employer committed to an inclusive and diverse workforce that creates a better future for our global communities. Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
LEO Pharma Inc. seeks information for job applications from candidates in the U.S. through only the following channels: the LEO Pharma Inc. website and Halogen Talent Acquisition, powered by Jobvite via email to/from addresses using only the LEO Pharma domain of "@leo-pharma.com" screening and interaction by telephone and through the Microsoft Teams platform.
LEO Pharma does not use Google Hangouts, Zoom or any other platform for any recruitment-related activities.
Disregard any solicitation or request for information related to job applications with LEO Pharma via any other means and/or using email addresses with any other domain.
LEO Pharma will never ask candidates to make any type of personal financial investment related to gaining employment with the company.
If you have any questions about LEO Pharma Inc. and the application process, please email the company's U.S. People and Communications team at [email protected]