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Years of Experience
Date Last Verified
Senior /Executive Director, Legal The candidate will serve as lead attorney and strategic legal business partner to the US Commercial team and member of US Commercial leadership team. Will provide comprehensive and high quality legal support to the US commercial business, including in the areas of sales, marketing and patient program review, government contracts and pricing, managed care, and compliance with federal and state anti-kickback statutes, federal false claims act, FCPA, FDA rules and regulations, HIPAA, product liability law, and other laws, rules and regulations applicable to the bio-pharmaceutical industry. Advise and consult with all levels of the organization including senior leadership to identify, analyse and offer practical solutions to critical business and legal issues. Partner with functional teams to establish a rapport and positive working relationship to encourage and continue the engagement of legal counsel in the achievement of business objectives, including commercial, regulatory, compliance, medical and patient advocacy. Draft, review and negotiate various commercial contracts. Support business development projects. Manage outside counsel.
Qualification and Experience
The candidate should have Juris Doctorate degree from an accredited law school . Licensed to practice law in the US and a member of good standing in the state(s) of admission is essential. Must have 10+ years legal experience including 5+ years at a pharmaceutical, biotechnology, medical device or other life sciences company Broad knowledge of the laws and regulations affecting the pharmaceutical industry, including FDCA, Anti-kickback statute, Sunshine Act, False Claims Act and FCPA is essential. Significant legal experience counselling commercial and other functions in anti-kickback statutes, FDCA rules, regulations, guidances and enforcement, OIG rules, regulations and guidances, FCPA and other laws applicable to the development, marketing and sale of pharmaceutical products as well as the US enforcement environment is essential. Must have experience supporting pre-launch and launch activities for pharmaceutical products and/or biologics; Experience reviewing advertising, copy and promotional materials, conducting product reviews, advising on reimbursement and patient support activities and reviewing product labels; Experience drafting and negotiating pharma-related commercial contracts (e.g. supply, manufacturing, distribution, clinical trial, managed markets) and/or other agreements; Experience advising company executives regarding programs and policies; Excellent academic and law firm credential. Strong verbal communication and presentation skills and writing skill is essential.
Requisition ID: 1351
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