Jobs · Legal · New Jersey

Director, Corporate Counsel

Otsuka Pharmaceutical Companies (U.S.) · Princeton, NJ · 4 days ago
Legal$186k/yrFull-time

About the role

The Director, Corporate Counsel will serve as a strategic legal advisor supporting U.S. commercial activities for one or more rare disease products. This role provides pragmatic, day-to-day legal counsel to brand, marketing, and cross-functional stakeholders, with a strong focus on advertising and promotion, product launch readiness, and commercialization strategy across the product lifecycle.

Responsibilities

  • Serve as lead legal advisor to assigned rare disease brand(s), providing strategic and tactical legal counseling across all commercial activities
  • Advises on day-to-day sales and marketing initiatives, campaigns, and brand strategies in alignment with legal, regulatory, and compliance requirements
  • Support pre-launch and launch readiness activities, including development of promotional strategy, messaging frameworks, and commercialization plans
  • Assess legal risk associated with commercial strategies and communications, and recommend mitigation strategies
  • Develop and contribute to policies, procedures, and training related to advertising and promotion and commercial practices
  • Provide training to internal stakeholders on legal and compliance requirements
  • Promotional Review & Advertising and Promotion
    • Participate as a core member of promotional review committees, providing legal review and guidance for: HCP and consumer promotional materials, digital, print, and social media campaigns, sales training and internal materials, market access and payer communications, patient support and disease awareness materials
    • Rare Disease–Specific Counseling
      • Advise on legal considerations unique to rare disease commercialization, including: small and highly targeted patient populations, diagnostic challenges and patient identification strategies, high-touch patient and caregiver engagement models, development of compliant approaches to disease awareness and education (prior to or independent of brand promotion), testing awareness, and patient journey messaging
    • Regulatory & Compliance Advisory
      • Counsel cross-functional stakeholders on applicable laws and regulations, including: FDA advertising and promotion requirements and OPDP enforcement trends, Federal Anti-Kickback Statute, False Claims Act, and OIG guidance, FTC advertising and endorsement guidelines, PhRMA Code and industry standards, Relevant state laws governing commercial practices
    • Commercial Programs & Engagement Models
      • Provide legal guidance on a range of commercial tactics, including: speaker programs and advisory boards, patient ambassador and testimonial programs, influencer and digital engagement strategies, copay programs, patient support services, and reimbursement communications, sponsorships, grants, and market research activities

Qualifications

  • Educational Requirements: Doctor of Jurisprudence (J.D.) or equivalent degree required
  • Experience: Minimum of 5-8 years of relevant experience as an attorney in the pharmaceutical or biotech industry. Substantial experience advising on branded pharmaceutical promotional review and commercialization issues.
  • Skills: Strong working knowledge of healthcare fraud and abuse laws, including the Anti-Kickback Statute, False Claims Act, and related enforcement risk areas. Familiarity with FDA requirements governing prescription drug promotion and labeling-related risk. Demonstrated ability to provide practical, business-oriented legal advice in a highly regulated and fast-paced environment. Strong judgment, communication, and cross-functional collaboration skills. Experience & demonstrated ability to collaborate, build and sustain effective partnerships with multicultural key stakeholders and project teams. Excellent written, verbal, and interpersonal communication skills. Ability to manage multiple priorities and work independently in a dynamic, cross-functional environment.

Preferred Qualifications

  • Experience supporting product launches and commercialization activities
  • Experience supporting rare disease products
  • Experience interacting with FDA/OPDP on promotional matters
  • Experience with specialty or complex therapeutic areas (e.g., neurology, genetic disorders)
  • Familiarity with patient support programs, access and reimbursement considerations
  • Experience supporting investigational or accelerated approval products

Benefits

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

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