Director, Corporate Counsel
Otsuka Pharmaceutical Co. - Princeton, NJ
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Serve as lead legal advisor for assigned marketed product(s) and provide practical, strategic counseling to brand teams and senior business leaders.Lead in legal review through the Promotional Review Committee, as assigned, and related review forums for:Consumer and HCP promotional materialsDigital, social, and print advertisingSales training materialsMarket access and payer-facing materialsField medical and medical information materialsCorporate affairs and external communications contentPatient support and disease awareness materialsAdvise sales, marketing, and commercial stakeholders on day-to-day business tactics, campaigns, and brand strategy in a manner consistent with legal, regulatory, and compliance requirements.Counsel on applicable laws, regulations, and guidance, including:FDA promotional requirements and enforcement trendsFTC advertising and endorsement requirementsCAN-SPAM and related digital marketing requirementsFederal Anti-Kickback StatuteFalse Claims ActOIG guidance and enforcementPhRMA Code and other industry considerationsState law considerations relevant to promotional and commercial practicesProvide legal guidance on common commercial and engagement tactics, including:Speaker programs and speaker trainingPatient ambassador and testimonial programsInfluencer and creator campaignsAdvisory boards and consultant engagementsCopay, patient support, and reimbursement-related communicationsMarket research, sponsorships, donations, and grantsMaintain a deep and current awareness of evolving applicable laws and regulations, as well as interpretations, advisory comments, enforcement actions and policy issues;Effectively partner with colleagues in Commercial, Promotion Compliance, Privacy, Compliance, Regulatory Affairs, Medical Affairs, Corporate Affairs, and/or Marketing Operations to respond to issues requiring legal support;Provide guidance to multi-functional teams to ensure compliance with company policies and legal/regulatory requirements; andPerform other legal, administrative and corporate duties upon request.Additional Director ResponsibilitiesSolutions Analysis: Analyze specific problems and issues to find the best solutions. Solutions could be technical or professional in nature.Policies and Procedures Development: Contribute to the drafting of policies, procedures, and related guidelines within an area of expertise to meet defined key principles and ensure compliance with external requirements.Internal Client Relationship Management: Contribute to the management of partnering relationships with internal clients, building effective working relationships, and providing high-quality professional services to support in delivering business strategy and plans.Information and Business Advice: Resolve queries from internal or external customers or suppliers by providing information on complex processes and the related policies, referring to others where necessary for interpretation of policy.Risk Scenario Modeling: Analyze, assess, and quantify the risks associated with products/individual applications/business activities/the market to determine whether any risk is within the agreed risk appetite. Undertake tactical risk modeling.QualificationsEDUCATION:Doctor of Jurisprudence (J.D.) or equivalent degree requiredActive membership in good standing in at least one U.S. state bar.EXPERIENCE:Minimum of 5 years of relevant experience as an attorney in the pharmaceutical industry or at a law firm advising pharmaceutical clients.Substantial experience advising on branded pharmaceutical promotional review and commercialization issues.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 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 teamsExcellent written, verbal, and interpersonal communication skills.Ability to manage multiple priorities and work independently in a dynamic, cross-functional environment.BEHAVIORAL COMPETENCIES:Decision Quality: Makes good and timely decisions that keep the organization moving forward.Ensures Accountability: Holds self and others accountable to meet commitments.Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.Persuades: Uses compelling arguments to gain the support and commitment of others. For example, states position with conviction and persuasive rationale.Develops Talent: Develops people to meet both their career goals and the organization’s goals.Optimizes Work Processes: Knows the most effective and efficient processes to get things done, with a focus on continuous improvement.Plans and Aligns: Plans and prioritizes work to meet commitments aligned with organizational goals.Customer Focus: Builds strong customer relationships and delivers customer-centric solutions.Business Insight: Applies knowledge of business and the marketplace to advance the organization’s goals.TECHNICAL COMPETENCIES:Questions Strategically: Works with limited guidance to uncover clients’ explicit needs and/or unforeseen opportunities and challenges.Analyze Alternatives and Recommend Solutions: Works at an intermediate level to analyze potential solutions and create recommendations based on the expected benefits, costs, and overall value of the solution for key stakeholders.Policy and Regulation: Works with limited guidance to interpret and apply knowledge of laws, regulations and policies in area of expertise.Effectively Presents Solutions: Works with limited guidance to clearly present solutions that link directly to the key objectives and challenges important to the client.Project Risk and Issue Management: Uses comprehensive knowledge and/or skills to act independently with guiding and training others on identifying, assessing, prioritizing and managing project related risks.
Created: 2026-03-24