Senior Corporate Counsel

2 days ago

Lake Zurich IL United States Fresenius Kabi USA, LLC Full time

Job Summary

The Senior Corporate Counsel provides healthcare, regulatory, corporate, and commercial legal support and advice for MedTech business unit. This role involves managing FDA submissions, reports, and communications (including handling product recalls and negotiating various contracts), ensuring compliance with global legal and regulatory requirements in advertising, promotion, and social media materials. It provides strategic legal advice on regulatory risks, product development, and compliance while reviewing product labeling, conference requests, and sponsorships. It also involves resolving disputes with suppliers, offering legal counseling on healthcare and corporate matters, collaborating across departments, staying updated on legal developments, and ensuring occupational and environmental safety compliance under ISO 14001 and ISO 45001 standards. Additionally, the role includes training business personnel on contracting policies and procedures.

Responsibilities

  • 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.
  • 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.
  • 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.

This job position within the Business Unit - Transfusion and Cell Technologies (BU-TCT) of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work-related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).

Requirements

  • JD from accredited law school and eligible to practice in-house in Illinois.
  • 12 years 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.
  • 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.
  • Demonstrated ability in healthcare, regulatory, and commercial legal matters.
  • Good analytical, research, drafting, negotiating, communication, and relational skills.
  • Ability to manage and prioritize multiple simultaneous demands and significant workload.
  • 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, as well as life insurance, disability, 401K with company match, and 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.

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