Fresenius Kabi USA
Corporate Counsel (Contracts)
Fresenius Kabi USA, Lake Zurich, Illinois, United States, 60047
Job Summary
Corporate Counsel (Contracts) at Fresenius Kabi USA. Provides corporate, commercial, healthcare, and regulatory legal support for the MedTech business unit. Drafts, reviews, revises product purchase, supply, manufacturing, distribution and other commercial agreements. Resolves disputes with suppliers, offers legal counseling on corporate and healthcare matters, collaborates across departments, stays updated on legal developments. Trains business personnel on contracting policies and procedures. Assists with FDA submissions, reports and communications including product recalls. Ensures compliance with global legal and regulatory requirements in advertising, promotion and social media materials. Provides strategic legal advice on regulatory risks, product development and compliance, while reviewing product labeling, conference requests and sponsorships.
Responsibilities
Draft, review, and revise product purchase, supply, manufacturing, distribution, license, capital expenditure, R&D, regulatory, quality, IT, service and other commercial agreements.
Lead negotiations of such contracts with clients and suppliers, with support from key stakeholders.
Support key commercial strategic initiatives and RFPs from customers.
Support insourcing and supply chain restructuring to improve cost savings, efficiencies, and quality.
Lead corporate entity and manufacturing licensing and registration programs and liaise with third‑party service providers to complete registrations.
Negotiate and resolve informal disputes with key suppliers and service providers.
Advise company on structuring business practices in compliance with applicable laws and regulations.
Handle FDA submissions, reports, communications and product recalls. Review and negotiate a variety of contracts.
Review internal and external communications related to regulatory and FDA matters.
Review advertising and promotion materials globally.
Review social media materials and respond to regulatory changes.
Advise business teams on legal and regulatory risks impacting their business.
Review conference requests and one‑time event and sponsorship opportunities.
Review new product labeling for compliance with laws and regulations.
Partner with other legal team leaders to support ongoing legal affairs.
Provide day‑to‑day legal counseling on healthcare, regulatory and corporate matters.
Participate as legal representative on cross‑functional teams and projects.
Stay current with legal, regulatory and government developments.
Provide direction to outside counsel and internal support staff.
Provide training and guidance to business personnel on contracting policies and procedures.
Interact and collaborate with a variety of departments at all levels.
Job Requirements
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 department.
Significant experience representing medical device, life sciences, and/or pharmaceutical companies, handling legal, regulatory requirements, including FDA submissions, product recalls and other matters.
Healthcare legal and regulatory experience is a plus, including Anti‑Kickback Statute, False Claims Act, Stark Law, HIPAA, privacy laws and PhRMA Code.
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.
Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, life insurance, disability, 401(k) with company contribution, and a wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Compensation Salary range: $160,000–185,000. Eligible for an annual bonus plan (target 16% of base salary) and a medium‑term incentive plan. Benefits include 401(k) with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits.
Position Details Location: Onsite 3 days per week at U.S. headquarters in Lake Zurich, IL. No visa sponsorship.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Legal
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr
Responsibilities
Draft, review, and revise product purchase, supply, manufacturing, distribution, license, capital expenditure, R&D, regulatory, quality, IT, service and other commercial agreements.
Lead negotiations of such contracts with clients and suppliers, with support from key stakeholders.
Support key commercial strategic initiatives and RFPs from customers.
Support insourcing and supply chain restructuring to improve cost savings, efficiencies, and quality.
Lead corporate entity and manufacturing licensing and registration programs and liaise with third‑party service providers to complete registrations.
Negotiate and resolve informal disputes with key suppliers and service providers.
Advise company on structuring business practices in compliance with applicable laws and regulations.
Handle FDA submissions, reports, communications and product recalls. Review and negotiate a variety of contracts.
Review internal and external communications related to regulatory and FDA matters.
Review advertising and promotion materials globally.
Review social media materials and respond to regulatory changes.
Advise business teams on legal and regulatory risks impacting their business.
Review conference requests and one‑time event and sponsorship opportunities.
Review new product labeling for compliance with laws and regulations.
Partner with other legal team leaders to support ongoing legal affairs.
Provide day‑to‑day legal counseling on healthcare, regulatory and corporate matters.
Participate as legal representative on cross‑functional teams and projects.
Stay current with legal, regulatory and government developments.
Provide direction to outside counsel and internal support staff.
Provide training and guidance to business personnel on contracting policies and procedures.
Interact and collaborate with a variety of departments at all levels.
Job Requirements
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 department.
Significant experience representing medical device, life sciences, and/or pharmaceutical companies, handling legal, regulatory requirements, including FDA submissions, product recalls and other matters.
Healthcare legal and regulatory experience is a plus, including Anti‑Kickback Statute, False Claims Act, Stark Law, HIPAA, privacy laws and PhRMA Code.
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.
Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, life insurance, disability, 401(k) with company contribution, and a wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Compensation Salary range: $160,000–185,000. Eligible for an annual bonus plan (target 16% of base salary) and a medium‑term incentive plan. Benefits include 401(k) with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits.
Position Details Location: Onsite 3 days per week at U.S. headquarters in Lake Zurich, IL. No visa sponsorship.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Legal
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr