Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead
1 week ago
Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead
Join to apply for the Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead role at Takeda
At Takeda, we are a forwardlooking, worldclass 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 lifechanging therapies to patients worldwide.
The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRAA&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.
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 Chairpause to communicate comments to coordinator, diffuse team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders, the patients.
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., Partner closely with linemanagement, Oncology GRA A&P Portfolio Lead and inform or bring in Head of GRA A&P for complex review concepts or topics.
Bachelors Degree in a sciencerelated field is required.
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.
Highly effective written and verbal communication skills to manage, motivate and drive decisions within teams.
Demonstrated crossfunctional people management with a desire to foster a positive team culture.
Previous experience in an advertising and promotion role.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and bestinclass patient support programmes. We are a Global Top Employer, encouraging innovation and striving for excellence in everything we do. We foster an inclusive, collaborative workplace, 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.
Massachusetts Virtual
Base Salary Range: The estimated salary range reflects an anticipated range for this position. S. based employees may be eligible for shortterm and/or longterm incentives, medical, dental, vision insurance, 401(k) plan with company match, shortterm and longterm disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, wellbeing benefits, up to 80 hours of sick time, and accrual of up to 120 hours of paid vacation.
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.
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Boston, MA, United States Takeda Full timeAssociate Director, Global Regulatory Affairs, Advertising and Promotion Join Takeda as an Associate Director, Global Regulatory Affairs, Advertising and Promotion . This role involves managing programs/products as the internal expert on US and international codes, guidance, and industry standards related to prescription medicine promotion. Key...
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Boston, MA, United States Takeda Pharmaceutical (US) Full timeBy clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. At Takeda,...
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Boston, United States Takeda Pharmaceutical Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
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Boston, United States Takeda Pharmaceutical Full timeBy clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
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Boston, MA, United States Takeda Pharmaceutical (US) Full timeBy clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
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Boston, United States Takeda Pharmaceutical (US) Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
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Boston, United States Takeda Pharmaceutical Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
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