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, and the unique legal and regulatory considerations associated with rare disease products, including disease awareness, patient identification, and specialized treatment pathways as well as sound judgment, strong cross-functional partnership skills, and the ability to deliver practical, risk-based advice in a fast-paced environment.
The ideal candidate must be able to competently and effectively evaluate legal risk and provide practical, business-oriented recommendations. A demonstrated ability to (i) ensure materials are consistent with FDA-approved labeling and compliant with applicable laws, regulations, and industry standards; (ii) provide legal guidance on promotional claims, disease state education, and scientific communications, particularly in complex or specialized rare disease contexts; (iii) monitor evolving regulatory requirements, guidance documents, and enforcement activity, and translate into actionable advice; (iv) partner closely with Promotion Compliance and Regulatory Affairs to ensure aligned, consistent guidance; (v) evaluate legal risk and provide practical, business-oriented recommendations; and (vi) collaborate with a variety of cross-functional partners, including Commercial, Medical Affairs, Regulatory Affairs, Ethic and Compliance, Privacy, Corporate Affairs and Communications, and Market Access and Channel teams.
Experience with contract drafting and negotiation is not required, but would be highly valued, particularly with respect to market access and channel arrangements. Experience in pharmaceutical pricing matters would similarly be highly valued.
Key Responsibilities
Commercial Legal Support & Brand Counseling
Serve as lead legal advisor to assigned rare disease brand(s), providing strategic and tactical legal counseling across all commercial activities
Advise 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
EDUCATION:
- Doctor of Jurisprudence (J.D.) or equivalent degree required
- Active membership in good standing in at least one U.S. state bar.
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.
Knowledge and 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.
Highly Preferred Qualifications:
Experience supporting product launches and commercialization activities strongly preferred
Experience supporting rare disease products strongly preferred
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
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Application Deadline: This will be posted for a minimum of 5 business days.
Company 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.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Otsuka America Pharmaceutical Princeton, New Jersey, USA Office
508 Carnegie Center, Princeton, NJ, United States, 08540
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