This role is responsible to build, drive, maintain and enforce an effective and comprehensive compliance program across the U.S. business in collaboration with the Head of Compliance (U.S.). Approximately 70% of the role will be focused on compliance, with 30% focused on legal.
• Partner with AAA’s Head of Compliance (U.S.) in advising commercial and medical colleagues on pharmaceutical regulatory matters and compliance laws, regulations, standards and policies that apply throughout the product lifecycle. Advise on compliance risks, evaluate programs and proposals, review promotional material, adapt compliance policies and support monitoring efforts. Subject matter includes Food Drug and Cosmetics Act, Sunshine Act (and state/local transparency laws), FDA Guidances on promotional review, HIPAA/GDPR, False Claims Act, Foreign Corrupt Practices Act, Anti-Kickback Statute.
• Work with AAA’s Head of Compliance (U.S.) to implement the recommendations of AAA’s internal compliance review. This will involve working with external advisors to adapt Novartis policies for AAA on a range of topics.
• Work with AAA’s Head of Compliance (U.S.) to establish a comprehensive, periodic compliance training program across the entire U.S. organization to establish, embed and enforce AAA’s compliance road map.
• Work with AAA’s Head of Compliance (U.S.) to implement a system for the complete reporting of payments to HCPs and HCOs for all U.S. transactions in scope for transparency reporting (i.e. Sunshine Act, state requirements and local requirements).
• Manage complex legal matters both as lead counsel and through coordination with AAA legal colleagues, attorneys in the Novartis Oncology Legal Team, and external lawyers, as appropriate. Provide trusted counsel to a broad range of internal stakeholders, including AAA’s executive committee, senior management, sales and marketing, regulatory affairs, medical affairs, research and development, and business development functions. Deliver 360-degree legal advice.
• Draft, negotiate and review a wide variety of agreements, including, licensing, joint venture, co-development, distribution, sales, research, feasibility study, material transfer, employment, consulting, service, CRO, CMO, clinical trial and confidentiality agreements. Jointly lead the three-person U.S. contract management team (two contract specialists and one contract administrator). Critical contracting projects throughout 2018-19 include Lutathera product purchase agreements, and PSMA clinical trial agreements and clinical research organization agreements.
• Implement strategic advice covering AAA’s extensive intellectual property portfolio. Establish strong relationships with cross-functional teams to harvest and protect new inventions. Manage external patent and trademark attorneys, and liaise with Novartis patent, trademark and name creation teams. Draft patent and know-how licensing agreements and manage patent due diligence in support of commercial deals.
• Facilitate dispute resolution in conjunction with external counsel; advise commercial colleagues on innovative marketing strategies; maintain corporate records and manage securities filings for a variety of subsidiaries as part of corporate secretary function; assist with commercial deal generation and execution; advise on employment law matters; procure and negotiate insurance policies. This is a generalist role that provides substantial opportunity for growth across all major aspects of pharmaceutical law and provides an ideal basis for development of thought leadership.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
• Juris Doctor or equivalent degree required.
• Bachelors Degree or equivalent required.
• Admission to the NY Bar or NJ Bar required.
• Minimum 2 years practicing law at a major law firm and/or life science company, preferably with significant relevant pharmaceutical law experience
• Demonstrated expertise negotiating, drafting and reviewing complex agreements
• Considerable knowledge of the pharmaceutical regulatory and compliance environment
• Strong business judgement with deep understanding of the pharmaceutical industry
• Excellent communication, interpersonal and presentation skills
• Strong negotiation and conflict management skills
• Good project management skills
• Exceptional analytical and organizational skills
• Ability to manage and influence across a cross-functional matrix organization
• Ability to manage high-volume of work in fast-paced environment
ADVANCED ACCELERATOR APPLICATIONS
East Hanover, NJ
AAA USA Inc.
Legal & Intellectual Property & Compliance