Description:

Position Overview:
This position is part of the Regulatory legal team, within the Legal Department, and will support the Kidney Care business globally. The position involves handling major projects, transactions or matters under the supervision of Associate General Counsel, Regulatory and has principal responsibility for planning and directing more discrete projects, transactions, or matters. Serves relevant business leadership and other law department members as a key advisor in defined areas of medical device and pharmaceutical regulatory law. In addition, this individual will be responsible for interpreting, negotiating and drafting clinical trial agreements and a variety of other agreements related to interactions with healthcare professionals/institutions.

The candidate selected for this role will:

Provide legal guidance and counseling to business and functional teams (such as sales and marketing, regulatory affairs, medical affairs, government affairs, patient access, clinical, quality, R&D, finance, and others).
Proactively identify and manage regulatory legal risks for highly complex/non-standard US/regional/global issues and develop/approve action plans.
Collaborate with legal colleagues and cross-functional teams to ensure appropriate expertise is applied to specialized issues, including regulatory strategy, product development & product approvals; advertising & promotion; post-approval compliance; FDA enforcement actions & litigation; due diligence reviews & transactional support.
Train business on legal topics including: Anti-Kickback Statute and safe harbors, good promotional practices, reimbursement and other relevant regulatory issues.
Support for M&A projects through due diligence review of regulatory issues and integration work.
Provide support to the Chief Medical Officer with respect to a wide variety of legal issues including contracts, technology transfers, regulatory considerations, general operating issues and international complexities.
Provide support to the Corporate Affairs group on government reimbursement issues.
Responsible for interpreting, negotiating and drafting clinical trial agreements and a variety of other agreements related to interactions with healthcare professionals/institutions, as well as handling other legal projects or matters as assigned.

Education and Experience:

JD or international equivalent from a nationally or internationally recognized institution; licensed in good standing to practice law in at least one state and one federal jurisdiction within the United States.
Minimum of 8-10 years of relevant professional experience with a mix of work in a high-caliber law firm, government agency, and/or comparable corporate environment.
Experience in the pharmaceutical or device industry, and/or similar healthcare regulatory experience.
Working knowledge in one or more of the following areas: Anti-Kickback Statute and False Claims Act, FDA promotional and other regulatory requirements from FDA, CMS, DEA, DOJ, and various state regulators, and industry codes governing interactions with healthcare professionals.
Experience with Government Reimbursement preferred but not required.

Essential Skills:

Strong business and personal ethics and integrity
Demonstrated experience as a valued business and regulatory lawyer and genuine team player.
Proven experience with counseling business clients on regulatory issues related to the Federal Food, Drug, and Cosmetic Act.
Dynamic and resilient individual with the demonstrated ability and confidence to make decisions and influence senior management, persuade, and build consensus across the business and functions.
Demonstrated ability to prioritize workload, meet deadlines and work with minimal supervision in a team and matrix environment, sound judgment and strong attention to detail??
Excellent written and oral communication skills
Experience in drafting and negotiating complex commercial, clinical trial and healthcare provider agreements.
Experience with complex commercial contracts and agreements including patient consents, investigator-initiated trials, sponsored research, material transfers, clinical supply, collaboration/partnering/joint research and development, confidentiality, contract research organization, laboratory service, research and development/medical/clinical services, consulting, manufacturing, quality, licensing and vendor services. Experience working with University technical teams globally; specific university experience in the US, Europe, China and India is especially relevant.