Directs or assists staff member(s) and independently reviews and approves promotional labeling materials and communications for prescription drug and medical device products. Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. May be assigned additional responsibilities as deemed necessary.
Job Description
Ensures promotional materials and communications are compliant with applicable laws, regulations, and company requirements. Analyzes and interprets new regulations and Guidance to Industry documents, and monitors the impact of Office of Prescription Drug Promotion (OPDP) correspondence and enforcement actions.
Reviews and approves promotional materials and provides strategic guidance on promotional messaging.
Provides strategic regulatory guidance during pre-launch and launch activities, including review of promotional claims, scientific communications, disease state education materials, and disease awareness initiatives.
Reviews promotional materials and communications to ensure consistency with approved product labeling, regulatory requirements, and appropriateness for the intended audience and use.
Partners cross-functionally with Commercial, Medical, Legal, and Regulatory teams to support launch activities and promotional strategy.
Responsible for final review and approval of promotional materials, sales training materials, and corporate communications.
Supports review of materials related to complex or highly specialized disease states, including diagnostic or testing considerations, patient identification, and disease education.
Ensures product promotional materials are submitted to OPDP on FDA Form 2253 in a timely manner and archived as per company policy.
Monitors changes in U.S. promotional regulations and corporate policies and procedures, and incorporates those changes into departmental processes, as appropriate.
Participates in cross-functional meetings and teams, including the Global Regulatory Team (GRT) and Global Labeling Team (GLT).
Participates in launch planning and cross-functional discussions for pipeline and commercialization activities.
Provides training to internal employees and affiliates on promotional compliance regulations, as appropriate.
Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate.
Qualifications
Required:
6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry
Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities
Experience supporting rare disease products
Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments
Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment
Solid understanding of U.S. regulatory requirements
Excellent understanding of medical concepts and terminology
Strong understanding of FDA advertising and promotion requirements and applicable product labeling
Fundamental understanding of the pharmaceutical industry drug development process
Preferred:
8+ years of experience supporting pharmaceutical advertising and promotion compliance activities
Experience supporting neurology or other specialty therapeutic areas preferred
Experience interacting with OPDP in support of launch programs preferred
Experience supporting investigational or accelerated approval products preferred
Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders
Able to work across multifunctional groups
Strong written and oral communication skills
Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat
The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. The candidate should be comfortable operating in a fast-paced environment, managing competing priorities, and providing practical, risk-based regulatory guidance to cross-functional stakeholders.
Educational Qualifications
Bachelor’s Degree required; Advanced scientific or clinical degree (e.g., PharmD, PhD, MS) preferred
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.