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Years of Experience
Date Last Verified
Senior Counsel, Responsibilities: Support research, development, marketing, promotion, and commercialization of pharmaceutical products. Draft, review, and negotiate strategic business agreements and transactions. Advise the business on regulatory, privacy, antitrust, advertising/promotional, and improper payments (eg. AKS, FCPA), matters. Provide regulatory and compliance advice and training, in conjunction with the Regulatory and Compliance specialist areas. Manage outside counsel, when brought in to assist. Manage/support the management of disputes, litigation, and incidents involving Core Imaging products. Apply combined business and legal judgment to proposed deals, relationships, and other issues requiring legal or compliance attention. Collaborate with regional legal colleagues and subject matters experts to analyze and advise the business on complex legal/compliance issues that arise out of Core Imaging’s global operations. Advise on legal issues involving pharmaceutical research and development, including: Preclinical and clinical research agreements for sponsored or funded project. Research compliance, e.g., registries and data transparency, patient rights, IRB interactions, informed consent. Agreements with research service providers. Collaboration and/or supply agreements with manufacturers of therapeutics. Participate on cross-functional committees, e.g., grant funding. Template development and management. Work with the business team as a business partner to identify opportunities to drive business forward, e.g. working with business development in structuring, negotiating, due diligence, closing and integration of complex acquisitions and investments, to develop legal processes/ templates for new business, commercial models and clinical studies. Support for business development activities focusing on agreements for co-development, co-promotion, and/or licensing projects. Coordinate with Senior Counsel, Life Sciences Core Imaging EMEA and regional counsel on global projects.
Qualification and Experience
Requirements: JD Degree (or global equivalent) with active Bar membership. 8+ years of relevant law experience at a large law firm or corporate legal department, including previous experience in drafting, negotiating and closing complex business transactions (i.e. purchase, sale and distribution agreements). Desired: Previous experience in identifying and resolving legal issues quickly and effectively and ability to make on the spot risk calls. Previous experience prioritizing conflicting demands from multiple business clients in an extremely fast paced environment. Ability to communicate using English; outstanding interpersonal skills. Experience in the Healthcare industry and previous exposure to healthcare industry regulations (FDA, Medicare/Medicaid anti-kickback). Experience with the US False Claims Act. Demonstrated experience providing legal advice in a highly-regulated environment.
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