Thank you for your interest in theAssociate Director, Complianceopportunity 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 fulfill 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.
About the Associate Director, Compliance:
The Associate Director, Compliance assists with all compliance activities in the US affiliate and help prepare the organization to execute on the LEO Global strategy, with primary responsibilities for providing compliance support to the teams responsible for pipeline products. Ensure ongoing compliance through auditing and monitoring of (a) pre and post-launch activities including Advisory Boards, promotional and medical interactions with HCPs and Payers and (b) post launch activities including Speaker Programs, patient assistance programs, co-pay programs and Field Reimbursement Activities and (c) as needed provide support to the LMR process.
Your contribution to the team includes:
Provide guidance on appropriate pre-launch and launch activities.
Develop audit checklists for pre and post launch activities that require compliance oversight and monitoring.
Develop checklists for monitoring of Field Reimbursement Managers, help desk, copay vendors and processes, Hub services and other patient assistance programs.
Pre-launch monitoring of Advisory Boards.
Pre-launch and post-launch monitoring of MMCD and CAM payor interactions.
As requested, review advertising and promotional materials, training materials, press releases and similar pieces relating to pipeline products.
Provide compliance guidance for LEO Affiliates engaging in activities in the US.
Assist with counseling and, where necessary, internal investigations related to violations of internal policies or the LEO Code of Conduct, as necessary.
Maintain awareness of relevant laws and regulations, keeping abreast of current changes that may affect the organization.
Draft/revise guidance documents.
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:
Juris Doctor required.
6-8 years prior in-house experience with a pharmaceutical, biotechnology or other life sciences company (experience with biologics preferred), including experience in pre-launch review of materials in a Legal review role and monitoring advisory boards.
Prior experience in compliance support and compliance monitoring.
Industry knowledge; keen focus on stakeholder management; ability to effectively manage ambiguity.
Experience operating and collaborating with Value Access, Marketing, Sales, Legal, Regulatory and Communications.
Team player with ability to manage projects independently.
Strong communication and presentation skills.
Good business/commercial understanding.
Working well in cross-functional matrix and preferably with Global functions.
Experience with the compliant use of RWE and HEOR data.
Experience with monitoring and providing guidance for activities relating to pipeline products.
Normally the role requires the ability to travel up to 20% of the time; however, the role may require increased ability to travel to monitor the anticipated 2021 product introduction.
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 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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