Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Manager, US Medical Ad / Promo Regulatory, Hematology / Rare Disease in our Lexington, MA 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 Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Manager US Medical Ad/Promo Regulatory, Hematology/Rare Disease working on the US Medical Ad/Promo Regulatory, Hematology/Rare Disease team, you will be empowered to serve as an internal resource on FDA regulations. In this role, you will contribute to Takeda s mission by providing regulatory guidance and expertise to promotional review team on the assigned products(s) of responsibility and identifies regulatory requirements and data needed to ensure claims are supported for product. A typical day will include:
- The Manager, US Medical Ad/Promo Regulatory, Hematology/Rare Disease serves as an internal resource on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
- Manages at least one (1) individual Brand or one (1) component of a therapeutic area (e.g., consumer or professional promotion) for multiple brands; supports other Ad/Promo Regulatory team members.
- Independently provides regulatory guidance and expertise to promotional review team on the assigned products(s) of responsibility and identifies regulatory requirements and data needed to ensure claims are supported for products.
- During the developmental stage, may be asked to provide promotional regulatory guidance for creation of the product labeling to enhance marketing of Takeda products.
- May support the preparation for FDA meetings.Assist and may, where appropriate, attend FDA meetings.
- Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial, and Compliance organizations and applies Regulatory knowledge to ensure promotional and non-promotional material development is accomplished following internal processes and standards, with some oversight from manager.
- Researches and evaluates advertisement and promotional precedents for marketed products to assist with providing well-supported and clear guidance to key stakeholders.
- Evaluates materials to ensure compliance with FDA regulations, guidance, corporate standards and policies and business objectives.
- Assesses the impact of proposed labeling changes for a particular product and its potential impact on advertising and promotional materials.
- May act as chair of promotional review meetings. Assists Commercial with the planning and prioritization of proposed promotional and disease state materials.
- Understands and interprets scientific data as it relates to regulatory requirements and strategy for given claims for therapeutic area(s).
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 3 years experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 1 year experience specific to Regulatory Affairs Advertising and Promotion. Candidates with experience in related fields may also be considered. Experience in Hematology or Rare Disease therapeutic areas preferred.
- Knowledge of FDA regulations.
- Understanding of scientific principles and regulatory/quality systems relevant to drug development.
- Ability to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 15% travel.
Empowering Our People to Shine
Discover more at takedajobs.com
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