Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead

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Job Description

About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead will support our growing Oncology Portfolio. You will be accountable for management of all assigned programs / products as the internal expert on US Codes, guidance, and industry standards pertaining to prescription medicine promotion.

How you will contribute :

Serve as GRA A&P SME for assigned products and projects.

Regulatory advisor as the “R” in the core Medical, Legal, Regulatory review functions of the Commercial Material Review Process (CMRP) and Medical Material Review Process (MMRP) for both Commercial and Medical material development, review, approval, and implementation

Product or project business lead for global CMRP at Takeda

CMRP Meeting Chair- pausing to communicate comments to coordinator, diffusing team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders which are the patients who trust us to do the right thing, and overseeing escalation steps if MLR cannot come to alignment or if there is new data or campaigns that require senior level management input or alignment.

Strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle

Subject matter expert on FDA code / regs, guidance, industry standards, complaints / violations, and innovative promotional platforms with additional training on International Codes (e.g.) EFPIA, IFPMA) and guidelines for Global product support

Partner closely with line-management, Oncology GRA A&P Portfolio Lead and inform or bring in Head of GRA A&P for complex review concepts or topics.

Empowered decision-maker within the CMRP.

Minimum Requirements / Qualifications :

Bachelor's Degree in a science-related field is required.

Master's Degree preferred. Minimum of 3 years’ experience required in material review and approval process of pharmaceutical / biologics promotion.

Ability to understand ABPI, EFPIA and other international code and guidance about advertising and promotion for prescription medicines.

Experience in prescription medicine promotion development and review process.

Strong interpersonal skills with ability to demonstrate strategic and analytic thinking.

Demonstrated ability to communicate clearly and concisely.

Highly effective written and verbal communication skills to manage, motivate and drive decisions within teams.

Proven skills in negotiation, influencing without authority and working diplomatically through conflict.

Demonstrated cross-functional people management with a desire to foster a positive team culture.

Ability to work independently, take initiative and complete tasks to deadlines.

Previous experience in an advertising and promotion role.

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" following Takeda's Hybrid and Remote Work policy.

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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 :

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and / or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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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