+ 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. 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. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. 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.
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