Associate Director Associate Compliance Counsel

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Associate Director, Associate Compliance Counsel
The candidate will be understanding of data and systems governance, and a demonstrated ability to work with minimal supervision, assess risk, and provide guidance to achieve outcomes compliant with applicable regulations and industry best practices. The Associate Director, Associate Compliance Counsel will provide risk mitigation and corporate compliance guidance to various R&D functions including but not limited to the Medical Affairs and Regulatory teams. Responsibilities will include providing support to field teams, guidance on HCP engagement, reviewing concept reviews, and ensuring compliance with relevant policies and regulations. J.D. from an accredited US law school. Licensed to practice law in at least one US jurisdiction. Minimum of 2 years of combined relevant experience as: (1) an in-house attorney at a pharmaceutical or medical device company, (2) regulatory counsel at FDA, and/or (3) a law firm attorney in a life sciences or healthcare regulatory practice. Experience with FDA regulatory approval process for pharmaceutical products. Understanding of the pharmaceutical product lifecycle. Knowledge of DOJ and OIG guidance regarding effective corporate compliance programs. Experience with the relevant legal and regulatory landscape, including, but not limited to fraud and abuse laws, (Anti-Kickback Statute, False Claims Act), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), anti-corruption (Foreign Corrupt Practices Act), and financial transparency (Physician Payments Sunshine Act). Familiarity with relevant industry codes, including the PhRMA Code and AdvaMed Code. Familiarity with GCP, ICH guidelines, and applicable regulatory requirements for clinical research. Project management experience with short-and long-term strategic planning experience. Experience or interest in digital health technology. Strong interpersonal skills.

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