Associate Director, Us Medical Advertising and

4 weeks ago

Lexington, United States ARIAD Full time

At Takeda, it's our people, our values and our culture that make us special. We share a sense of vocation and a desire to serve others that pulses through our entire organization. We're fortunate to be grounded in a history that gives us a long term perspective, the confidence to stick to what we believe in, and the humility to know we don't have all the answers.

We combine this outlook with an agility and tenacity to deliver for our patients that has fueled the growth of our business. But what really sets our company apart is something we call Patient Trust Reputation Business. It's the framework that enables us to translate our purpose and values into action. It's how we synchronize the diversity of our perspectives, strengths and expertise. And it’s what keeps our decision making tethered to what really matters.

**Job ID** R0122352**Date posted** 05/10/2024**Location** Lexington, MassachusettsThe Associate Director, US Medical Ad/Promo Regulatory serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will be able to provide regulatory strategic oversight for at least one complex product or therapeutic area for assigned US products and/or compounds. You will understand and interpret complex issues in relation to regulatory requirements and promotional strategy.

Purpose:

- Mentor and develop staff. Supervise, trains and provides technical and regulatory guidance to staff.
- You will serve as the chair of promotional review meetings, and assist commercial with the planning and prioritization of proposed promotional and disease state materials.
- You will serve as primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products.
- Ensures consistent review standards within the electronic approval system (EAS) are upheld, and business needs are assessed and addressed.
- Supports metrics to measure and track the effectiveness and efficiency of the promotional review process and provides recommendations for process improvements to address potential issues.

Accountabilities:

- Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance, execute and approve key Commercial campaigns. Provide expert guidance to help evaluate and mitigate potential risk.
- Be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The role thoroughly reviews and assesses proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements.
- Understand broad concepts within Regulatory Affairs and possible effects across the organization. Identify regulatory issues. Offer creative solutions and strategies, including risk mitigation strategies.
- Provide product development and label development strategies, as needed, to ensure promotional claims can be supported.
- May provide direct supervision of individuals including mentoring, performance management, and staffing decisions. Identify and propose solutions to management for any resource gaps for brand responsibilities.
- Presents to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.
- Serves as primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding the use of claims for assigned business unit/therapeutic areas.
- Leads internal Ad/Promo project workstreams (e.g., best practice documents) and active participant at team staff meetings.
- Collaborates with the International Regulatory Ad/Promo review teams for materials that are intended for global audiences.

Experience/Qualifications:

- Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
- You will have knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences.
- Previous experience in Regulatory Affairs promotion and advertising; experience in managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
- Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams.
- Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights.
- You will understand the phases, processes and techniques used within a clinical development environment, can cont

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