Commercial and FDA Regulatory Counsel

POSITION ID: FDACNSL 1268
CATEGORY:
PRACTICE AREA: , ,
LOCATION: New Jersey
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Princeton Legal Search Group has been retained on an exclusive basis by Mitsubishi Tanabe Pharma America,  a global specialty pharmaceutical company with US headquarters in Northern New Jersey. Our client is seeking an experienced commercial and FDA regulatory lawyer for a dynamic role in which you will provide advice on legal and regulatory issues as they arise in connection with marketing, sales, medical, market access, and operations.

You will be involved in all aspects of the commercial business and operate as part of a team focused on supporting an orphan drug in the U.S. You will be responsible for reviewing promotional and nonpromotional/scientific materials and strategies, evaluating strategic and tactical commercial/brand and medical affairs plans, clinical educator programs, and advising clients on a broad array of issues relating to FDA pharmaceutical regulations, advertising, marketing, product development, product labeling, promotional review, media materials, anti-trust, anti-kickback, competitor issues, market access issues, regulatory policy, medical, pricing, reimbursement, privacy, sales, industry and group company issues and transactional matters.

In this role you will work on cross-functional business teams, including direct contact with senior leaders including the President.

Responsibilities:

  • Review promotional materials and tactics including social media and healthcare professional and consumer-directed advertising as well as nonpromotional/scientific pieces and scientific exchange materials. Participate in review committee meetings.
  • Provide strategic advice regarding customer and other stakeholder relationships, regulatory matters, contracts and interactions with respect to branded/specialty pharmaceuticals. Ensure optimal advice regarding sales & marketing, interactions with healthcare professionals, interactions with patients and patient advocacy groups, clinical educator programs, market access, medical affairs, product sourcing and development, and competition practices.
  • Supervise outside counsel.
  • Responsible for assisting in supporting compliance function; helping to create and deliver training to clients.

Qualifications:

  • Juris Doctorate (J.D.) degree from a nationally recognized law school.
  • Admitted to the Bar of at least one state and eligible for admission to the New York or New Jersey Bar as in-house counsel.

Required Experience:

  • Minimum of 5-10 years of legal experience, either in a law firm or in-house in the pharmaceutical or related industry, is required.
  • Previous in-house experience with legal support for specialty/branded pharmaceuticals is preferred.
  • Experience with FDA laws and regulations, in particular promotional and nonpromotional review, and guidance provided by the Office of the Inspector General for HHS is required.

Required Skills and Traits:

  • Excellent oral and written communication skills; strong presentation skills, with the ability to communicate abstract ideas and legal advice to executive and senior management as well as non-legal colleagues and non-native English speakers.
  • Excellent critical thinking skills; ability to work through complex issues, including those with significant strategic risk to the company.
  • Strategic, analytical thinker and creative problem solver who possesses innovation, client management, demand management skills and regulatory knowledge.
  • Strong organizational skills with the ability to handle and prioritize a high volume of work and independently manage multiple complex projects simultaneously.
  • Energetic self?starter with demonstrated influencing skills and a results orientation. Must be able to quickly gain the trust and respect of senior executives, peers and clients.
  • Ability to work both in a strategic big picture mode, as well as tactically, including the capability to “roll up one’s sleeves” and work in detail.
  • Flexible, and possessing a commercial, business focus in approaching this position.

Salary commensurate with experience. Bonus eligible position.

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