Associate General Counsel at Zelis managing labor and employment law for a growing healthcare financial company. Providing legal advice and support to the People and Culture Team across various employment - related issues.
About the role
- Corporate Counsel responsible for legal guidance on healthcare and regulatory matters for Fresenius Kabi's MedTech business unit. Involves drafting and negotiating contracts and compliance oversight.
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
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 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
- Good working knowledge of healthcare and other laws, regulations, and industry codes applicable to medical device and pharmaceutical companies
Benefits
- 401(k) plan with company contributions
- Paid vacation
- Holiday and personal days
- Employee assistance program
- Health benefits including medical, prescription drug, dental and vision coverage
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