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Job Description

Associate Director, US Advertising & Promotion Regulatory (A&P Excellence)

Takeda Pharmaceutical

USA-MA-Virtual

About the role:

Join Takeda as an Associate Director, US Advertising & Promotion Regulatory (A&P Excellence) where you will be working on the US Medical team. In this role, you will be empowered to serve as an internal expert on A&P Excellence standards, FDA regulations, guidance's, and enforcement trends governing the promotion of prescription drug and biologic products. In addition, you will contribute to Takeda's mission by providing regulatory review support to help ensure regulatory compliance of promotional materials generated for assigned product(s), as well as other responsibilities that advance Takeda's reputation externally. This role reports to the Senior Director, US Advertising & Promotion Regulatory (A&P Excellence).

How you will contribute:

• Develop and execute Regulatory A&P-focused training, process improvements, A&P Excellence tools and standards within the department, and to other stakeholders across the US Business Unit [approximately 80% of job responsibility].

  • The A&P Excellence aspect of this role presents a unique opportunity to focus on facilitating compliant and compelling promotional materials through cross-functional education, process optimization, and the creation and dissemination of standards and other tools.

  • Develop and plan Training Sessions and Materials for the Regulatory A&P Team and cross-functional stakeholders, including enduring assets for recurring needs (e.g., New-Hire Training Program).

  • Help design and perform needs analyses to develop a prioritized action plan for training and standards development, and other critical projects.

  • Identify emerging topics for on-demand training and educational needs.

  • Assist in developing and delivering Regulatory A&P Intelligence resources that enable Takeda to stay informed and involved in the evolving regulatory landscape.

  • Modernize and maintain department repository for A&P Excellence training materials and standards.

  • Manage service provider contracts as needed.

• Provide Regulatory A&P Review support for at least one (1) US product or one (1) component of a US therapeutic area (e.g., Consumer, HCP or Payor promotion), with supervision and guidance from a supervisor/coach [approximately 20% of job responsibility].

  • Be the chair of promotional review meetings and assist Commercial with the planning and prioritization of proposed promotional and disease state materials

  • Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance to help execute and approve key Commercial campaigns.

  • Provide expert guidance to help evaluate and mitigate potential risk.

  • Research and evaluate advertising and promotional precedents for marketed products to help provide well-supported and clear guidance to key stakeholders

  • Evaluate materials to ensure compliance with FDA regulations, guidance's, corporate standards, policies, and business objectives.

  • Work with New Product Planning group to provide US Regulatory A&P support for pipeline/early development projects.

  • Participate in Global Regulatory Team for the supported product(s).

  • Participate in Label Working Group for the supported product(s), assessing the impact of proposed labeling changes on advertising and promotional materials.

  • Support other Regulatory A&P team members as needed.

• During the product development stages, may be asked to provide promotional regulatory guidance for creation of the product labeling to help enhance the marketing of Takeda product(s).

• Other duties as assigned.

Minimum Requirements/Qualifications:

• Bachelor's Degree in life science or equivalent required. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.

• Minimum of 5 years' experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years' experience specific to Regulatory Affairs – Advertising and Promotion.

• Knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professional, payor and consumer audiences.

• Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for the 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.

• Excellent oral and written communication skills, time management, and negotiation skills are expected. This individual must be able to work well with others, especially on cross-functional teams.

• The ideal candidate for this role should be passionate about process optimization, standardization, training and educating others.

• Prior experience developing standards, SOPs, work instructions, or other internal training materials is preferred.

• Travel Requirements: approximately up to 15% travel; willingness to travel to various meetings or client sites, including overnight trips and some international travel may be required

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$153,600.00 - $241,340.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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