[Hiring] Director, Corporate Counsel @Otsuka Pharmaceutical Co., Ltd.

Role Description

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.

This attorney will operate as a key partner to Commercial, Medical, Regulatory, and Promotion Compliance teams, delivering risk-based legal guidance in a fast-paced, highly regulated environment. The role requires deep understanding of:

• FDA promotional requirements
• Healthcare fraud and abuse laws
• Unique legal and regulatory considerations associated with rare disease products

The ideal candidate must be able to competently and effectively evaluate legal risk and provide practical, business-oriented recommendations:

• Ensure materials are consistent with FDA-approved labeling and compliant with applicable laws, regulations, and industry standards
• Provide legal guidance on promotional claims, disease state education, and scientific communications
• Monitor evolving regulatory requirements and translate into actionable advice
• Partner closely with Promotion Compliance and Regulatory Affairs
• Collaborate with a variety of cross-functional partners

Key Responsibilities

• Commercial Legal Support & Brand Counseling
  • Serve as lead legal advisor to assigned rare disease brand(s)
  • Advise on day-to-day sales and marketing initiatives
  • Support pre-launch and launch readiness activities
  • Assess legal risk associated with commercial strategies
  • Develop and contribute to policies, procedures, and training
  • Provide training to internal stakeholders
• Promotional Review & Advertising and Promotion
  • Participate as a core member of promotional review committees
  • Provide legal review and guidance for HCP and consumer promotional materials
  • Review digital, print, and social media campaigns
  • Review sales training and internal materials
  • Review market access and payer communications
  • Review patient support and disease awareness materials
• Rare Disease–Specific Counseling
  • Advise on legal considerations unique to rare disease commercialization
  • Address diagnostic challenges and patient identification strategies
  • Support high-touch patient and caregiver engagement models
  • Develop compliant approaches to disease awareness and education
• Regulatory & Compliance Advisory
  • Counsel cross-functional stakeholders on applicable laws and regulations
  • Provide guidance on FDA advertising and promotion requirements
  • Advise on Federal Anti-Kickback Statute and False Claims Act
  • Discuss FTC advertising and endorsement guidelines
  • Review PhRMA Code and industry standards
  • Address relevant state laws governing commercial practices
• Commercial Programs & Engagement Models
  • Provide legal guidance on speaker programs and advisory boards
  • Advise on patient ambassador and testimonial programs
  • Support influencer and digital engagement strategies
  • Guide copay programs and patient support services
  • Review sponsorships, grants, and market research activities

Qualifications

• Doctor of Jurisprudence (J.D.) or equivalent degree required
• Active membership in good standing in at least one U.S. state bar
• Minimum of 5-8 years of relevant experience in the pharmaceutical or Biotech industry
• Substantial experience advising on branded pharmaceutical promotional review and commercialization issues
• Strong working knowledge of healthcare fraud and abuse laws
• Familiarity with FDA requirements governing prescription drug promotion
• Demonstrated ability to provide practical, business-oriented legal advice
• Strong judgment, communication, and cross-functional collaboration skills
• Excellent written, verbal, and interpersonal communication skills
• Ability to manage multiple priorities and work independently

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage
• Company provided basic life, accidental death & dismemberment insurance
• Short-term and long-term disability insurance
• Tuition reimbursement and student loan assistance
• A generous 401(k) match
• Flexible time off and paid holidays
• Paid leave programs and other company provided benefits