A leading wound care and therapeutic biologics company is looking to hire a Director of Compliance/Compliance Counsel. The role report to the Chief Compliance Officer and have responsibilities assisting with the day to day responsibilities of the compliance program and providing advise and guidance on a number of legal matters.
Responsibilities:
- Leading the development, implementation, and maintenance of a comprehensive compliance program.
- Draft, implement and train on company compliance policies.
- Provide strategic legal and compliance advice to the business to ensure compliance with applicable U.S. laws and company policies, including federal and state antikickback and false claims laws, the federal Food Drug and Cosmetic Act (FDCA) laws, federal and state transparency laws (e.g., Open Payments), the PhRMA Code, state laws, and antitrust laws.
- Manage and conduct compliance investigations.
- Understand and advise the company regarding new and existing compliance issues and related policies and procedures.
- Develop and conduct annual risk assessment and mitigation plans.
Requirements:
- JD degree required and a minimum of 5+ years of broad experience in pharmaceutical, biotech and/or medical device industry (in-house preferred)
- Excellent communications skills and the ability to communicate complex concepts
- Strong understanding of compliance processes and activities common to biotech/pharmaceutical industry
- Solid presentation skills, including, but not limited to, leading internal trainings and experience presenting to a board of directors and its committee
*This role can sit fully remote*
