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Fresenius Kabi USA · 1 month ago

Corporate Counsel (Contracts)

Lake Zurich, IL

Full-time

Hybrid

Mid, Senior Level

$160K/yr - $185K/yr

3+ years exp

Fresenius Kabi USA is seeking a Corporate Counsel to provide legal support for its MedTech business unit. This role involves drafting and negotiating various commercial agreements, advising on regulatory compliance, and collaborating with cross-functional teams to ensure legal and regulatory adherence.

Health Care

No H1B

Responsibilities

Drafting, reviewing, and revising product purchase, supply, manufacturing, distribution, license, capital expenditure, research & development, regulatory, quality, information technology, service and other commercial agreements

Acting as a lead in negotiation of such contracts with relevant counterparties, both clients and suppliers, with support from key business stakeholders where required

Supporting key commercial strategic initiatives and requests for proposals from customers

Supporting insourcing and supply chain restructuring efforts to improve cost savings, efficiencies and quality standards

Leading corporate entity and manufacturing licensing and registration programs and liaising with third party service providers to complete registrations

Negotiating and resolving informal disputes with key suppliers and service providers

Advising the Company on structuring business practices in compliance with applicable laws and regulations, including, but not limited to, those related to the federal and state anti-kickback law, DEA, FDA and state boards of pharmacy, among others, and staying current with developments regarding same

Handling FDA submissions, reports, communications with the FDA (including Form 483s and Consent Decrees), product recalls, and reviewing and negotiating a variety of contracts including vendor, manufacturing, clinical trial/research, and other agreements

Reviewing internal and external communications (e.g., press releases or talking points) related to regulatory and FDA matters

Reviewing advertising and promotion materials in view of legal and regulatory requirements globally

Reviewing social media materials and responding to changing regulatory and legal landscape related to online product promotion

Advising business teams on legal and regulatory risks impacting their business, including regulatory strategy, product development, product approvals, and post-approval compliance

Reviewing conference requests and other one-time event and sponsorship opportunities in view of applicable healthcare guidance and regulations

Reviewing new product labeling for compliance with applicable laws and regulations

Partnering with other legal team leaders to support the ongoing legal affairs of the corporation

Providing day-to-day legal counseling on healthcare, regulatory, and corporate legal matters, including engagement with healthcare providers

Participating as legal representative on various cross-functional teams and projects

Staying current with legal, regulatory, and governmental developments impacting the Company and industry

Providing direction to outside counsel and internal support staff

Providing training and guidance to business personnel on contracting policies and procedures

Interacting and collaborating with a variety of departments within the Company at all levels, including upper management

Qualification

JD from accredited law school3+ years legal experienceFDA submissions experienceHealthcare legal experienceRegulatory compliance knowledgeAnalytical skillsResearch skillsDrafting skillsRelational skillsPrivacy lawsNegotiating skillsCommunication skills

Required

JD from accredited law school and eligible to practice in-house in Illinois

3+ years of relevant legal experience at a top law firm and/or in-house legal department

Significant experience representing medical device, life sciences, and/or pharmaceutical companies, handling legal and regulatory requirements, including FDA submissions, product recalls, and other regulatory matters

Demonstrated ability in healthcare, regulatory, and commercial legal matters

Good analytical, research, drafting, negotiating, communication, and relational skills

Good working knowledge of healthcare and other laws, regulations, and industry codes applicable to medical device and pharmaceutical companies

Preferred

Healthcare legal and regulatory experience is a plus, including experience with the Anti-Kickback Statute, the False Claims Act, the Stark Law, HIPAA, applicable privacy laws and the PhRMA Code