This role will be a lead commercial and regulatory attorney providing business-focused strategic counsel on a broad array of commercial-related matters in support of the Company’s product portfolio and product candidates including pre-launch initiatives relating to product labeling, promotional review, compliance, FDA pharmaceutical regulations and requirements, advertising, and educational programs. This position will report to the General Counsel and will work collaboratively with other members of an expanding in-house legal team while working cross-functionally in a fast-paced, highly motivated, and driven-by-results focused culture. This position will have significant opportunity to expand his / her legal base within our rapidly growing business.
Essential Job Functions:
Serve as the lead attorney and strategic advisor for a wide range of regulatory matters including: Fraud and Abuse, Stark/Anti-Kickback issues, FDA marketing (advertising, promotion, labelling) and other FDA regulatory including clinical R & D issues, impact of proposed legislation and reporting requirements (state and federal), and other regulatory matters
Advise and consult with all levels of the organization including senior leadership to identify critical legal issues, assess potential legal options, and provide individuals and teams with an analysis and range of possible legal solutions
Partner with Compliance Team in the implementation and continued education of the Company’s company-wide compliance program
Partner with teams to establish a rapport and a positive working relationship, particularly within the corporate office and Field Commercial Team, to encourage and continue engagement of legal counsel in the achievement of objectives and goals
Review, analyze and advise for each therapeutic area, matters related to reimbursement activities, access services, patient support and assistance programs
Draft and provide legal and strategic advice on pharmaceutical industry commercial agreements such as distribution agreements, and master service and vendor agreements; draft and negotiate clinical trial agreements and pharma-related commercial contracts including managed care or GPO agreements and supply, manufacturing, distribution, CTAs, MTAs
Partner with Compliance and Business teams to ensure policies and procedures meet internal and regulatory standards
Understand regulatory and business context and ability to shape content to fit within the company’s prescribed policy framework
Negotiate with sophisticated counterparties, such as hospitals, academic institutions and clinical research organizations
Providing legal advice for a wide range of matters, including product pricing and corporate communications and governance
JD from an accredited law school
Strong academic credentials
18+ years legal experience with at least 5 years of experience advising in the pharmaceutical/biotech industry with a demonstrated interest in and understanding of commercial and business matters.
Significant legal experience and knowledge base in fraud and abuse counseling and FDA issues, with a working understanding of the OIG’s Guidance for the Pharmaceutical Industry, applicable regulations and laws relating to the development and marketing of pharmaceutical products, the enforcement landscape from a U.S. Department of Justice, FDA and State perspective
Preferred experience working at a leading U.S. national law firm in conjunction with an in-house counsel position with a leading biotech/pharmaceutical company with significant marketed products
Expertise in counseling clients on best practices for Commercial and Regulatory functions
Experience working with and advising business clients directly, as well as providing guidance and practical solutions
Broad knowledge-base of the laws and regulations affecting the pharmaceutical industry, including the Food Drug and Cosmetic Act, Anti-Kickback Statute, and False Claims Act
Excellent negotiation skills requiring effective interpersonal communication and oral and written communication skills
Ability to draft and negotiate a wide range of commercial transactions including but not limited to vendor/procurement agreements, sales/service agreements, non-disclosure agreements, and licensing, distribution, and manufacturing agreements
Ability to provide legal counsel to a wide variety of internal teams on legal and regulatory matters and interact effectively with employees at all levels of the organization
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