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Associate Director of Compliance, Madison, New Jersey

Created 12/02/2021
Reference oNPKhfwn
Category Legal and Compliance
Job type Full Time
Country United States
State New Jersey
City Madison
Zip Not specified
Salary Competitive

The Associate Director, U.S. Compliance has responsibility for supporting and maintaining key compliance systems, processes and support across a variety of compliance program elements and business areas. In this role, the individual will provide support for key compliance programs, processes, tools, technology, and analytics, and be an integral part of the U.S. Compliance function. This individual will ensure compliance support is aligned with LEO Pharma's values and standards and consistent with local industry code, best practices, PhRMA Code, and U.S. laws and regulations.The role has a primary focus on Compliance investigations, risk assessment, remediation and tracking, and third-party risk management framework.


The successful candidate will be a compliance generalist and will support the development and enhancement of LEO Pharma Inc's Compliance program ensuring effective elements of compliance and implementing and maintaining a robust, dynamic and effective corporate compliance program. We are looking for a personable and experienced Associate Director, Compliance with a deep understanding of both the applicable laws and the day-to-day business of a pharmaceutical company, as well as the strong ability to communicate and apply legal and compliance principles to effectively mitigate risk.

Essential Functions

Responsibilities may include support in the following areas:
  • Manage and conduct compliance investigations involving potential violations of corporate policies, laws or regulations and oversee corrective action
  • Work with internal audit team to provide input on audit plans and work with the business to timely complete corrective action plans
  • Support the development and execution of risk assessments and follow up to ensure effective remediation
  • Oversee corrective action plans in partnership with functional leadership for resolution of problem areas or gaps
  • Develop third party risk management framework
  • Assist Compliance colleagues in assessing, establishing, enhancing and implementing changes to compliance program policies, procedures, and process to meet applicable requirements and address key emerging risks
  • Partner cross-functionally to foster a culture of compliance in the company's interactions with healthcare professionals
  • Support Compliance program and initiatives related to Sales, Marketing, Market Access, and Medical Affairs
  • Supports the Senior Director's reporting to the US Compliance Committee and the Senior Director's overall compliance governance responsibilities
  • Assist with analysis, reports and statistics reflecting monitoring and auditing outcomes to identify areas of program enhancement
  • Other compliance projects as assigned

Required Experience:
  • Experience supporting Commercial and Medical areas.
  • Bachelor's degree required; MA, MBA, 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/or other risk areas and 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
  • Demonstrated understanding and experience developing Compliance program policies and governance structures, which include controls and requirements that incorporate key elements of OIG guidance and the U.S. Department of Justice Criminal Division Evaluation of Corporate Compliance Programs.
  • Excellent communication and organizational skills and attention to detail
  • Team player with demonstrated ability to develop, maintain and grow relationships
  • Direct multiple projects simultaneously, honing analytic and project management skills
  • Willingness for occasional travel domestically/internationally
  • Must be able to perform all essential functions of the position, with or without reasonable accommodation.

Ready to learn more about LEO Pharma?
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 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.

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 [email protected]