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This position will provide legal support in the areas of contract review, compliance, and training. Its focus will be the overall support of the sales and marketing efforts, as well as addressing FDA, regulatory, and reimbursement matters regarding innovative healthcare products. The position will report to the company’s general counsel.
Responsibilities and duties include, but are not limited to, the following:
Proactively collaborate with functional and business partners on new as well as ongoing commercial strategies, thereby identifying and analyzing legal risks and proposing appropriate actions to secure compliance with relevant rules, regulations, and policies.
Review product advertising materials for compliance and respective policies and applicable laws.
Partner with Regulatory Affairs on establishing and maintaining best practices and policies for interactions with healthcare professionals and patients and ensuring compliance with relevant laws.
Provide regular trainings and updates on legal and compliance topics to diverse groups within the company.
Assess current company policies versus legal requirements, industry association codes, and industry best practices and cross functionally coordinating changes and improvements where necessary, also eliminating redundant policies where reasonable.
Draft, negotiate, and review agreements and contracts on non-disclosure, consulting, service, consignments, terms and conditions, and commercial documents relevant to operations, including but not limited to agreements with vendors, customers, third-party payers, as well as healthcare professionals and medical institutions.
Ensure consistency of contract terms with Company policies and goals, offering alternative courses of action to advance Company interests.
Reduce Company’s contract risk, work with general counsel and other departments to develop contract strategies.
Assist general counsel where necessary and required in employment law and litigation matters
Perform other duties as assigned.
J.D. from an accredited law school.
A minimum of 5-7 years of relevant experience
Experience drafting, negotiating and advising on contracts across a broad range of scope, including service agreements, deliverables, marketing/advertising agreements, procurement agreements, and others.
Good working knowledge of federal and state laws applicable to the commercialization of life science industry regulated products.
Strong oral and written communication skills.
A member in good standing of one state bar.
In-house experience in the broader life sciences industry.
Experience in the life sciences practice of an AmLaw 100 law firm.