Job Summary

The Corporate Counsel provides corporate, commercial, healthcare, and regulatory legal support and advice for the MedTech business unit. This role involves drafting, reviewing and revising product purchase, supply, manufacturing, distribution, and other commercial agreements. The role also involves resolving disputes with suppliers, offering legal counseling on corporate and healthcare matters, collaborating across departments, and staying updated on legal developments. The role also includes training business personnel on contracting policies and procedures. Additionally, the role involves assisting with FDA submissions, reports, and communications (including handling product recalls), 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.

Salary Range: $160,000 - $185,000 per year. Position is eligible to participate in a bonus plan with a target of 16% of the base salary. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.

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.
• 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 us