Director, Corporate Counsel

* 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.- **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.* 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.- **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.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.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 Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. #J-18808-Ljbffr Otsuka Pharmaceutical Co., Ltd