Sr. Corporate Counsel, Promotional Review

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!  

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. 

 Why you’ll love working at Axogen: 

• Friendly, open, and fun team culture that values unique perspectives 
• Company-wide dedication to profoundly impacting patients’ lives 
• Comprehensive, high-quality benefits package effective on date of hire 
• Educational assistance available for all employees 
• Matching 401(k) retirement plan 
• Paid holidays, including floating holidays, to be used at your discretion 
• Employee Stock Purchase Plan 
• Referral incentive program 

If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/ 

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Sr. Corporate Counsel

Axogen is the leader of peripheral nerve repair and is dedicated to improving patient outcomes through our innovative products. The Sr. Corporate Counsel, Promotional Review will report directly to the Deputy General Counsel. The primary focus of the Sr. Corporate Counsel, Promotional Review is to evaluate promotional and other materials to ensure compliance with legal and regulatory standards for company’s biological and medical device products. The attorney may also provide support for other departmental priorities and needs. The Sr. Corporate Counsel, Promotional Review will interface daily with in-house colleagues and collaborate with cross-functionally with colleagues from Marketing, Medical Affairs and Regulatory.

Requirements of the Sr. Corporate Counsel

• J.D. from ABA accredited law school.
• 5-7 years of legal expertise supporting biological and med device product review. Experience with biologics review is required; medical device product experience is a plus.
• Deep understanding of FDA regulations, advertising guidelines and the pharmaceutical/biologics industry legal landscape.
• Experience with International Promotional Review is a plus.
• Experience managing a large volume of promotional review materials.
• Experience working with Veeva Vault / PromoMats is a plus.
• Strong work ethic: willingness to learn new skills and acquire new departmental experiences.
• Excellent written and oral communication skills.
• Proactive and able to function effectively in environment of rapidly changing demands.
• Ability to work independently with minimal supervision.

Responsibilities of the Sr. Corporate Counsel

• Provide timely, legal review and advice during Medical, Legal, Regulatory (MLR)/Pharmaceutical Review Committee (PRC) to ensure Axogen’s promotional activities comply with FDA Regulations, industry guidelines and company policies.
• Review promotional materials for biological product, including social media, scientific exchange, healthcare professional, patient support, and consumer-directed advertising.
• Work closely with marketing, to develop promotional strategies including policies and procedures to improve review process.
• Flexibility to adapt and thrive in an environment that is constantly expanding and changing as Axogen grows its business.
• Familiarity with U.S. healthcare compliance, including anti-kickback and Health Economic communications, is a plus.
• Keep abreast of and proactively address changing regulations, industry, and market trends.
• Develop and implement promotional review training.
• Performs other related duties as assigned.
• Location: Tampa, FL or Alachua, FL.

 

Location

111 West Oak Ave., Tampa, FL  33602

OR

13631 Progres