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Pharmaceutical commercial organization in Central New Jersey is seeking a Brand/Commercial Counsel to join its team. This person will provide legal counsel to the company’s pharmaceutical commercial organization in the USA.
The attorney will be involved in all aspects of the commercial business and operate as part of a team focused on commercializing a recently approved orphan-designated product in the USA.
The attorney will be responsible for advising clients on a broad array of issues relating to FDA pharmaceutical regulations, advertising, marketing, product development, product labeling, promotional review, anti-trust, anti-kickback, competitor issues, compliance issues, regulatory policy, and transactional matters.
This lawyer will work on cross-functional business teams, including direct contact with the President, Chief Commercial Officer, Chief Medical Officer and Vice President of Operation; and will report to the Assistant General Counsel for the healthcare businesses of the holding company.
Sufficient legal experience, preferably in-house at a major pharmaceutical company or at a major law firm counseling pharmaceutical companies.
Experience with FDA regulations and guidance provided by the Office of the Inspector General for CMS required.
Excellent interpersonal skills, excellent oral and written communication skills, qualities as a self-starter and the ability to work well independently and as part of a team.
Excellent judgment and the knowledge and ability to involve others that may possess the needed expertise to address issues as required.
Experience launching a pharmaceutical product in the USA is highly desirable.
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