- Serve as lead commercial attorney for apraglutide, in addition to supporting LINZESS other commercial products and/or development assets as needed.
- Provide Ironwood commercial team with advice on issues relating to the commercialization of apraglutide, including claim development and marketing strategy, market research, state licensing, global market access and healthcare economics initiatives.
- Lead drafting and negotiating contracts for commercial and Medicare Part D coverage, as well as government contracts and trade/distribution agreements.
- Provide advice and guidance on issues pertaining to best price, AMP, ASP, and federal and state price reporting.
- Advise patient support team on patient programs, including, but not limited to call center support, education, reimbursement assistance and expanded use programs.
- Serve as a member of Ironwood's Labeling and Pricing Committees, as well as serve as the legal representative on the promotional materials review committee for apraglutide.
- Participate as the legal representative on other commercial and medical scientific affairs committees on an as-needed basis and, in collaboration with Compliance, provide legal review of various business materials relating to apraglutide, LINZESS and/or other products, including brand plans, training materials, corporate communications, medical plans, etc.
- Stay abreast of and communicate to the organization significant legal developments, legislation and regulatory rulings that may affect the company in the area of commercial healthcare law.
- Establish a strong rapport and a positive working relationship with associates at all levels, particularly within the Commercial organization.
- Serve as a subject matter expert in areas of healthcare regulatory law, including rules and regulations of the FDA, OIG and CMS and antikickback legislative obligations, Stark Law, qui-tam risks, and product liability statutes and regulations.
- Respond to questions from the research and development organization on an as-needed basis, including questions related to conduct of clinical trials in the United States and abroad.
- Work collaboratively with Compliance colleagues to develop and implement training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance and educate clients and partners about current enforcement trends.
- Supervise external legal counsel.
- J.D. from a law school accredited by the American Bar Association (ABA)
- Admitted to practice law in one or more states
- 8 – 10 years of relevant experience as a commercial product attorney for a pharmaceutical company and/or life sciences law firm
- Expertise in commercial healthcare and FDA regulatory law, specifically related to market access, pricing and price reporting, patient support, government contracting matters, and other laws and regulations related to the development and commercialization of pharmaceutical products
- Experience in supporting a company transitioning from pre-commercial to commercial-stage
- Experience in rare disease a plus
- Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, state marketing compliance laws, as well as various anti-bribery and privacy laws
- Proven track record of accomplishment in the area of drafting and negotiating contracts and otherwise supporting all aspects of a commercialized pharmaceutical brand
- Self-motivated, strong leadership, work well independently on projects, meet deadlines in fast-paced environment, handle multiple projects, technical knowledge, business acumen, and excellent communication skills
- Ability to work in a collaborative, global environment and handle multiple complex and confidential tasks
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Commercial Counsel - Boston, MA, United States - Ironwood Pharmaceuticals
Description
The Commercial Counsel, will serve as lead commercial counsel supporting apraglutide, Ironwood's product candidate in Phase 3 development for the potential treatment of rare gastrointestinal (GI) diseases, including short bowel syndrome with intestinal failure and acute graft-versus-host disease. In addition, the Commercial Counsel also will support Ironwood's in-market product, LINZESS (linaclotide), as well as other pipeline assets as needed.The Commercial Counsel, principally will be responsible for supporting market access/payor contracting, distribution, pricing, and patient support services for apraglutide, as well serving as Ironwood's lead attorney on government contracting matters. Additionally, this individual will serve as a member of Ironwood's Pricing and Labeling Committees, and will serve as the legal representative on Ironwood's promotional review committee for apraglutide. The individual will provide counsel and advice that contributes to the overall legal risk assessments to ensure appropriate and comprehensive understanding of potential enterprise risk, escalation, and resolution as relates to apraglutide, LINZESS, as well other commercial products and/or development assets. This role will report directly to the Chief Compliance Officer, Commercial Counsel and work closely with the VP, Deputy General Counsel and the Chief Legal Officer.A successful candidate for this role will leverage their knowledge of commercial healthcare and FDA regulatory law to support apraglutide through the final stages of development and, if successful and approved, to market. Further, a successful candidates will be a solution-oriented self-starter who is able to work well independently, demonstrates an ownership mindset, and as serves key legal business partner through close collaboration with internal and external business partners, including in Ironwood's commercial team. Responsibilities
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