Thank you for your interest in theCompliance Analystopportunity based at LEO Pharma U.S. headquarters in Madison, NJ. or remote.
At LEO Pharma, we seek passionate, entrepreneurial and solutions-oriented colleagues, and consistently ensure that our people can proactively develop their capabilities and fulfil their potential. Together, we can embrace the changing healthcare landscape and grasp strategic business opportunities. The result: life-enhancing products that bring hope to patients living with chronic dermatologic diseases.
Your contribution to the team includes:
(1)Serve as the transparency reporting specialist supporting all business areas in complying with Aggregate Spend laws and regulations. In this capacity, the Compliance Analyst is the primary contact, support resource, liaison, and coordinator in the following areas:
Electronic & Manual data capture, cleansing, householding and submission for all LEO ?applicable manufacturers?
Maintenance and management of all transparency data, including uploads to appropriate aggregate spend software systems
Federal and State transparency payment reporting and monitoring
(2)Assist with the preparation, submission, tracking and maintenance of State Manufacturer or Wholesaler licensure applications and existing licenses
(3)Ensure State Drug Price Transparency registrations are prepared and filed, including processing fee payments as required.
(4)Support Stature Committee and assist in the administration of the HCP engagement compliance software platform.
Spend Disclosure
Responsible for collecting, monitoring, auditing and analyzing aggregate spend data for reporting under the Physician Payment Sunshine Act (Open Payments) and state disclosure laws as well as managing the remediation of data for completeness and accuracy.
Responsible for working with business units to develop and implement tracking mechanisms and processes to facilitate capture of all HCP-related spend for federal and state reporting purposes
Responsible for ensuring the accuracy and timeliness of all federal and state disclosure filings.
Train third-party vendors regarding their responsibility to assemble accurate data and submit in a timely manner to LEO in the proper format.
Responsible for monitoring data feeds of HCP spend data from internal and external sources, communicate issues/findings to business units and vendors, and facilitate remediation.
Responsible for managing the process for handling physician disputes and inquiries, assisting with responses and resolutions.
Registration and Licensures
Assemble materials needed to support the application and renewal process
Prepare, file, arrange payment for and post State licensure applications and renewals
Ensure required State Drug Price Transparency registrations are prepared, filed and fees are paid.
Stature Committee
As primary contact person, responsible for initial intake and subsequent tracking of credentialing/FMV determination requests for HCPs under consideration for projects, through completion of evaluation
Aligns with Stature Committee Coordinator to manage workflow and ensure all tasks are complete and accurate
Assist in the creation and maintenance of MedCompli entries for each individual who has been credentialed and who has been background checked, updating as necessary.
Will also work with the LEO Global Healthcare Compliance Group to ensure the LEO US data is properly provided (as necessary) to our Global Colleagues.
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.
Required Experience:
Master?s degree within natural science or equivalent.
5+ years? seniority within regulatory 5+ years, with primary responsibility of having achieved major local regulatory milestones, including drug development milestones (e.g., pre-IND, National Advice) and/or life cycle management milestones (e.g., line extensions).
Broad business understanding and knowing the business and the impact of the project.
Advanced understanding of the entire drug development/LCM process and how the development/LCM program and needed Health Authority interactions/filings/label.
Understanding of science and data relevant for development and LCM.
Expert regional regulatory guideline, requirements and precedence to inform strategic regional considerations.
Regional business acumen.
Ready to learn more about LEO Pharma?
LEO Pharma has been pioneering medical innovations for more than 110 years. Today, LEO Pharma looks to constantly improve and extend what is possible for the benefit of patients. Our rapidly expanding product portfolio and pipeline includes global therapeutic areas in psoriasis, eczema, skin infections, acne, rosacea and, most recently, rare disease.
LEO Pharma believes in challenging the status quo, so we approach dermatology ?beyond the skin.? Our global innovation ecosystem includes internal research and development, digital health via the LEO Innovation Lab, based in Copenhagen, and the LEO Science & Tech Hub, housed in Cambridge, Mass.
As we look to shape our U.S. footprint now and in the future, we pride ourselves on our agile and entrepreneurial environment. It allows passionate people to collaborate and push the boundaries of science in hopes to provide solutions for patients.
Perks
We offer a competitive compensation package, 401k match, vision, dental and health insurance, annual bonus, three weeks? vacation to start, a culture that emphasizes work-life balance, both paternity and maternity leave, free membership to the on-site gym, bagel Monday?s and - most of all - a FUN and celebratory work environment.
Let?s wrap this up
If you are interested in joining a growing and nimble company, and help shape the future of medical dermatology, then send in your resume today!
EEOC
A diverse workforce fosters innovation and strengthens Leo Pharma?s mission. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
Thank you for your interest in career opportunities at LEO Pharma Inc.
Please note:
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 **********.
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