Title: Senior Director, Excellence and Operations, US Medical Ad/Promo Regulatory
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Director, Excellence and Operations, US Medical Ad/Promo Regulatory in our Exton office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Senior Director, Excellence and Operations working on the US Medical Ad/Promo Regulatory team, you will be empowered to serve as a resource to colleagues and provide leadership. In this role, you will contribute to Takeda s mission by helping to develop regulatory standards. A typical day will include:
- The Sr Director, Excellence and Operations, US Medical Ad/Promo Regulatory is responsible for supporting US Ad/Promo Reg excellence, innovation and training across US business units.
- This role will serve as a resource to colleagues within US Ad/Promo Regulatory and is responsible for addressing primary escalations from Ad/Promo Reg team members (e.g., evaluate feasibility, risk assessment and compliance with regulatory requirements and internal policies and procedures).
- The role provides leadership of the promotional review process and is responsible for developing Regulatory standards for US Ad/Promo Reg team across the respective business units.
- This position maintains an expert understanding of FDA regulations, guidance and enforcement trends and is able to apply that knowledge and expertise to support innovative practices in Ad/Promo and functional training needs.
- The role provides leadership of the promotional review process for at least one (1) therapeutic area/ Commercial project and is responsible for thoroughly assessing proposed promotional strategies/materials to evaluate feasibility, risk assessment and compliance with regulatory requirements and internal policies and procedures.
- Establishes and maintains favorable interactions with FDA
- Develops Reg standards to support consistent implementation across the various US business units.
- Works with Ad/Promo team members to proactively identify potential regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
- Evaluates opportunities to support and advance Ad/Promo Reg excellence, including in digital/social media and health economic tactics.
- Evaluates materials, as assigned, to ensure compliance with FDA regulations, guidance, corporate standards and policies and business objectives. In collaboration with Commercial, Medical and Legal colleagues, conducts a detailed evaluation of the adequacy of clinical evidence provided to support proposed claims that are consistent with product labeling, while preempting areas of potential concern related to proposed promotional materials. Provides consistent, well-supported, and clear guidance to key stakeholders.
- Assists the Head of US Medical Ad/Promo Regulatory with aligning the promotional review processes and standards to ensure materials are compelling, compliant and reviewed in a timely manner.
- Maintains an expert understanding of OPDP and/or APLB requirements, as well as a keen awareness of FDA enforcement trends.
- Serves as a liaison with OPDP and/or APLB reviewers for business-critical initiatives and potential challenges.
- Working with promotional review leadership, monitors metrics to measure and track effectiveness and efficiency of the promotional review process; provides recommendations to promotional review leadership for process improvements to address issues, gains agreement on process improvements from key stakeholders, and helps implement agreed-upon process improvements.
- Responsible for keeping up-to-date in digital advancements and best practices in Ad/Promo practices.
- Serves as liaison between Regulatory Operations and Ad/Promo to ensure appropriate and timely processes for 2253 submissions
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
- Ideal candidate has a minimum of 10 years experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 8 years experience specific to Regulatory Affairs Advertising and Promotion.
- Expert knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences, which serves as the foundation for the development of Regulatory standards across the respective business units.
- Extensive experience in managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
- Expert knowledge of digital/social media and health economic trends.
- Provides expert regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
- Provides leadership related to issues of critical importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights.
- Maintains a current knowledge of applicable government regulations, particularly those related to advertising and promotion including major global codes of practice and regulations. Has extensive knowledge of historical enforcement actions and is readily able to use this when offering recommendations to senior leadership.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately up to 20% travel
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.