Mitsubishi Tanabe Pharma

Brand Lawyer

Job Locations US-NJ-Jersey City
Job ID
2020-1455
# of Openings
1
Category
Legal

Overview

The Brand Lawyer will provide legal services and support, primarily to Mitsubishi Tanabe Pharma America, Inc. (MTPA) and its affiliated companies. This is a dynamic role giving advice on legal and regulatory issues as they arise from the marketing, sales, medical, market access, operations and executive teams.  He/she 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. The attorney will be responsible for reviewing promotional and nonpromotional/scientific materials and strategies, evaluating strategic and tactical commercial/brand and medical affairs plans, supporting 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. The Brand Lawyer will work on cross-functional business teams, including direct contact with senior leaders including the President. He/she will not be directly responsible for contract review, but will be responsible for advising the transactional attorney on regulatory and compliance risks.

 

This position is based in Jersey City, NJ with quarterly staff meetings held in NYC.

Responsibilities

  • Advises on the proper review of promotional materials and tactics including social media and healthcare professional and consumer-directed advertising as well as nonpromotional/scientific pieces and scientific exchange materials. Participates in review committee meetings.
  • Provides strategic advice regarding customer and other stakeholder relationships, regulatory matters, contracts and interactions with respect to branded/specialty pharmaceuticals. Ensures optimal advice regarding sales and 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.
  • Works closely with the transactional attorney and advises on specific regulatory or compliance risks, and counsels management in connection with related matters.
  • Partners with legal department colleagues in executing and enhancing Company objectives.
  • Supervises outside counsel.
  • Drives increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the local business. Demand management is key, as are innovative solutions to meet client needs and address highest risks.
  • Works as part of a matrix leadership team at MTPA (handling matters including commercial, medical, operations and HR).
  • Assists in supporting compliance function; helps to create and deliver training to clients.
  • Leads by example and ensures consistent communication to clients; serves as a beacon of compliance and representative of the compliance program.

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.
  • 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.
  • 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.
  • Selfless, promoting team and company objectives over individual accomplishments.
  • Strong organizational skills with the ability to handle and prioritize a high volume of work and independently manage multiple complex projects simultaneously.
  • Demonstrated broad understanding of the business environment and capable of anticipating future challenges resulting from change and the ability to adapt quickly and keep up with a fast‐paced and highly demanding environment and regulatory framework.
  • Ability to respond resourcefully and strategically to shifting priorities and work effectively in ambiguous or challenging situations.
  • 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.
  • Demonstrated client service orientation; able to recognize and respond quickly and pragmatically to urgent situations and demanding clients while setting demand management and expectations for highest priority matters.
  • Flexible, and possessing a commercial, business focus in approaching this position.
  • Knowledge of Japanese business practices is not required but would be ideal.
  • Required to travel up to 10% including to New York City for quarterly department-wide staff meetings.

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