US Commercial Lead

US Commercial Lead
Position Summary:
The Sr./Executive Director, Legal is the lead US commercial and regulatory attorney providing business focused strategic counsel to the US Commercial team on a broad array of commercial related matters in support of the Company's product portfolio, pre-launch and launch activities, including product launch planning, promotional support, FDA regulations, and compliance. This position will report to the General Counsel and will work collaboratively with a cross-functional commercial team, the legal team and with outside counsel. This position will have significant growth potential.
Roles and Responsibilities
Serve as lead attorney and strategic legal business partner to the US Commercial team and member of US Commercial leadership team
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
JD from an accredited law school required
Licensed to practice law in the US and a member of good standing in the state(s) of admission
10+ years legal experience including at least 5 years at a pharmaceutical, biotechnology, medical device or other life sciences company
Experience and Skills
Broad knowledge of the laws and regulations affecting the pharmaceutical industry, including FDCA, Anti-kickback statute, Sunshine Act, False Claims Act and FCPA.
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
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 credentials
Excellent negotiation skills and ability to interact with all levels of the organization
Strong verbal communication and presentation skills and writing skills.
Ability work to collaboratively with individuals having diverse educational and cultural backgrounds.

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