The ideal candidate brings substantial experience advising on issues affecting commercialized pharmaceutical products, including review of promotional and non-promotional materials, field medical content, market access communications, sales training, patient support initiatives, and/or external engagement programs. This role requires sound judgment, strong cross-functional partnership skills, and the ability to deliver practical, risk-based advice in a fast-paced environment. The candidate must demonstrate the ability to understand and apply legal risks within his/her areas of responsibility, and clearly and appropriately communicate those risks for client consideration. As a Director within the Legal team, it is expected the individual will also work independently, be able to develop well- reasoned positions, and know when to appropriately escalate complex and unique topics for further discussion and consideration.
Experience with contract drafting and negotiation is not required, but would be highly valued, particularly with respect to technical operations, supply chain, and market access arrangements.
This role can be located in Otsuka’s Princeton, NJ or Rockville, MD offices, or it can be remote, but availability during US Eastern time zone business hours is mandatory. No matter where the role is located, up to 25% travel is required based upon business needs.
At Otsuka our mission is to create new products for better health worldwide. Our purpose is to defy limitation so others can too.
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.
- 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 materials
- Digital, social, and print advertising
- Sales training materials
- Market access and payer-facing materials
- Field medical and medical information materials
- Corporate affairs and external communications content
- Patient support and disease awareness materials
- Advise 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 trends
- FTC advertising and endorsement requirements
- CAN-SPAM and related digital marketing requirements
- Federal Anti-Kickback Statute
- False Claims Act
- OIG guidance and enforcement
- PhRMA Code and other industry considerations
- State law considerations relevant to promotional and commercial practices
- Provide legal guidance on common commercial and engagement tactics, including:
- Speaker programs and speaker training
- Patient ambassador and testimonial programs
- Influencer and creator campaigns
- Advisory boards and consultant engagements
- Copay, patient support, and reimbursement-related communications
- Market research, sponsorships, donations, and grants
- Maintain 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; and
- Perform other legal, administrative and corporate duties upon request.
Additional Director Responsibilities
- Solutions 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.
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 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 teams
- Excellent 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.
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.
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