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Senior Counsel, Business Law The candidate will be collaborating with other brand attorneys, IP, Compliance, Regulatory and other business groups to ensure robust, integrated and complete client counseling. Will be proactively counseling Oncology Business Unit to appropriately execute oncology strategy and brand objectives Leading and managing the overall legal risk assessments to ensure appropriate and comprehensive understanding of potential enterprise risk, escalation, and resolution. Provide focused legal support, in collaboration with other attorneys, for global oncology commercial and late stage development products. Serve as legal advisor/core brand attorney to commercial, medical affairs, market access, distribution and development teams, as assigned, for late stage products and marketed products. Lead assigned cross-functional legal initiatives and serve as lead lawyer on cross-functional commercial teams including without limitation, brand team, promotional and other material review committees and medical drug information. Collaborate with R&D, IP, Compliance colleagues involved with late stage clinical and marketed products with responsibility for ensuring an aligned approach across multiple products. Review business materials (including brand plans, promotions, medical plans, training documents) requiring legal input and advising internal clients, partners and stakeholders on compliant strategies, plans and tactics. Advise cross functional teams including clinical, product development, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use. Counsel on appropriate relationships with a variety of external parties, including healthcare professionals, patients, academic institutions, and payors. Work collaboratively with Compliance colleagues to develop and implement training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance and educate clients and partners about current enforcement trends. Should have 10+ years of experience in pharmaceutical in-house commercial product matters. Experience supporting a pharmaceutical commercialized brand is required. oncology legal background, experience with pharmaceutical promotional review, and/or experience with regulatory for draft labels and label updates is preferred. Licensed to practice law in Massachusetts, or qualified to practice in the Commonwealth under another license is essential.
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