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Manager, US Medical Ad/Promo Regulatory

Exton, Pennsylvania, Lexington, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Self-starter
  • Versatile
  • Team player

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Opportunity

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Our vision is of a world with accessible healthcare for all, where prevention measures are exponentially advanced and billions are freed of disease. Our approach is rooted in our patient-centricity and the creation of outstanding treatments that change people's lives. Building upon a foundation of sustainability, we are committed to contributing to the long-term health of people through disease prevention.

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Manager, US Medical Ad/Promo Regulatory

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Job ID R0013932 Date posted 01/09/2020 Location Exton, Pennsylvania; Lexington, Massachusetts

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Manager Regulatory Affairs Promo/Advertising in our Lexington, MA or Exton, PA 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.

POSITION OBJECTIVES: 

  • The Manager, US Medical Ad/Promo Regulatory 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.

POSITION ACCOUNTABILITIES: 

  • 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).
  • Understands broad concepts within regulatory affairs; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies; demonstrates increasing independence beyond single therapeutic area.
  • 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.
  • Other duties as assigned.

EDUCATION, EXPERIENCE, KNOWLEDGE 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.
  • Knowledge of FDA regulations. 
  • Understanding of scientific principles and regulatory/quality systems relevant to drug development.
  • Maintains current knowledge of applicable government regulations, particularly those related to advertising and promotion including major global codes and regulations. Has knowledge of historical enforcement actions and is readily able to use this when offering recommendations to stakeholders.
  • Ability to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
  • Ability to deal with issues of critical importance, provides regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory guidance.
    • Demonstrates problem-solving ability and generates alternative solutions prior to elevation of issues to manager.
    • Excellent oral and written skills, timeline responsibilities, negotiations skills. Works well with others, especially on a cross-functional team.
    • Models leaders at all levels daily.

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings, including overnight trips.
  • Requires approximately up to 15% 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

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Locations

Lexington, MA

L-Shire - United States - Exton PA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0013932

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