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Corporate - General Attorney / Food & Drug Administration Attorney in Richmond, VA

Indivior PLC Sep 08,2017 Jul 20,2017 Location Richmond VA
This job is expired...

In-House

Attorney

Corporate - General

Litigation - Regulatory Enforcement (SEC, Telecom, Energy, etc.)

10-15 yrs required

Profile

Assistant General Counsel, North America The candidate will focus on providing effective legal advice and counsel in connection with pre-launch, launch, and post-launch commercial initiatives. Serve as legal advisor to the Commercial, Global Strategy, Medical Affairs, Regulatory, Clinical and other related departments in connection with the design and evaluation of pre-launch, launch, and post-launch commercial initiatives. Provide high quality and timely legal advice and counsel to the Commercial, Global Strategy, Medical Affairs, Regulatory, Clinical and other related departments. Analyze business and commercial initiatives and providing advice and counsel on applicable laws and regulations, including but not limited to antitrust, commercial, false claims/anti-kickback, fraud and abuse, and other related healthcare compliance laws, regulations and requirements. Provide legal advice and business counsel on innovative business, commercial, and development strategies, including but not limited to marketing and sales strategies, activities and programs, review of advertising and promotional strategies and materials, and working with clients to develop appropriate and compliant strategies for interacting with external parties. Provide legal advice and counsel on market access, pricing, reimbursement, government pricing matters including but not limited to price reporting, federal contracting requirements, pricing and reimbursement advice, Medicare (Parts B and D), Medicaid and other Public Sector Reimbursement Programs (e.g., 340B, DoD, VA), commercial contracting, specialty pharmacy and specialty distributor matters, and GPOs. Partner with other members of the Legal, Governance and Compliance and other departments on statutory, regulatory and policy interpretation, and assist in providing related advice, counsel, training and other related activities. Provide legal advice and counsel on matters related to the development of access services, patient support and assistance programs, and educational materials. Draft, review and negotiate a variety of contracts including, but not limited to, master service, consulting, vendor, market research and trade related agreements. Assist with special projects as assigned by the Chief Legal Officer. Juris Doctor and an active license to practice law in the US (in good standing) required. 10-15 years of experience as an attorney in the pharmaceutical or biotech industry required. Extensive knowledge: and experience in commercialization of products and new products in all phases including pre-launch, launch, and post-launch, as well as branding, promotion and ensuring compliance with applicable laws, rules and regulations; and experience with, FDA regulations applicable to the pharmaceutical industry; experience drafting and negotiating contracts; with dealing with controlled substances, risk mitigation programs, REMS and non-REMS products required. Experience managing a significant number of projects simultaneously and to thrive in a dynamic and fast paced environment required. Excellent judgment and ability to work independently and as a team to manage various tasks and simultaneously balance competing priorities to meet tight deadlines required. Excellent interpersonal, written and oral communication skills required. Global/International product launch experience preferred.

Additional info

Job ID: R130

Company info