Senior Legal Counsel

1 week ago

Berkeley Heights, United States Breckenridge Pharmaceutical Full time

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group's own R&D facilities and through strategic partnerships with manufactures from around the world.

The Senior Counsel will provide general legal support, including corporate/commercial, regulatory, and compliance support relating to the Company's transactional, regulatory, compliance and other activities. This position requires excellent written and oral communications skills, and the ability to work with all departments across the Company (including business development, operations, finance, regulatory and sales), domestic and international partners, outside counsel and licensing and regulatory authorities.

RESPONSIBILITIES

  • As a member of the Legal Department of Breckenridge Pharmaceutical, Inc. ( BPI or the Company ), the Senior Counsel will provide general legal, corporate, commercial, and regulatory support relating to all the Company's activities, including transactional, and regulatory.
  • Report to BPI's Senior Associate General Counsel ( Sr. AGC ).
  • Draft, review and negotiate U.S-related corporate and commercial agreements including those for purchase, sale, supply, non-disclosure, licensing, joint development, business development, research and development, manufacturing, distribution, services, M&A transactions, procurement, quality and pharmacovigilance.
  • Conduct legal due diligence for product development and M&A transactions.
  • Review and analyze existing agreements and counsel the business, including senior management, regarding the Company's rights and obligations.
  • Support state compliance activities, including state drug distribution licensing and state price transparency.
  • Support Sr. AGC with management of corporate compliance program, including drafting corporate policies and procedures, structuring compliance programs, and assisting with training BPI personnel on policies and procedures.
  • Assist with compliance and maintenance of corporate books and records, and business registrations.
  • Maintain current knowledge and understanding of various laws, regulations, industry guidance and best industry practices that are relevant to or impact BPI operations. Review and analyze various federal and state laws and regulations as necessary.
  • Perform general and legal-related industry research.
  • Assist with other activities as requested by BPI's VP, General Counsel and Head of Litigation and/or Sr. AGC.

JOB REQUIREMENTS:

Education:

  • JD degree from accredited U.S. law school (or the equivalent).
  • Admission to the Bar of a U.S. state or the District of Columbia and eligible for admission to practice in New Jersey.

Experience:

  • 5+ years of corporate, commercial and IP transactional experience (preferably concerning the pharmaceutical industry either in-house or at a law firm, together with experience in regulatory and compliance matters applicable to the U.S. pharmaceutical industry.
  • Knowledge and understanding of the various laws, regulations and industry guidance including, but not limited to, transactional matters (e.g., drafting, reviewing and negotiating corporate, commercial and procurement contracts), fraud and abuse (e.g., Anti-Kickback Statute, False Claims Act, Anti-Trust), FDA regulatory matters, and general corporate governance.
  • Experience in generic pharmaceuticals preferred.
  • Life sciences litigation and intellectual property experience, including development of IP strategies for product development a plus.

Required:

  • Ability to operate independently and handle multiple responsibilities simultaneously.
  • Strong interpersonal and communication skills, able to deal with people from all different backgrounds and cultures.
  • Demonstrated ability to: (i) understand and digest complex scenarios in order to identify relevant issues and risks; (ii) propose solutions that take into consideration the relevant business objectives; and (iii) communicate those issues, risks, and solutions clearly and concisely.
  • Flexible, collaborative and team-oriented approach to problem-solving.
  • Excellent written, oral and presentation skills.
  • Sound judgment and commitment to ethical conduct.

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