Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead
Takeda
Full-time
Remote friendly (United States)
United States
Medical Affairs
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Role Summary
Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead will support the Oncology portfolio, serving as the internal expert on US codes, guidance, and industry standards pertaining to prescription medicine promotion.
Responsibilities
- Serve as GRA A&P SME for assigned products and projects.
- Regulatory advisor 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—communicate comments, diffusing disputes, negotiating, and overseeing escalation steps when alignment is needed or new data/campaigns require senior input.
- Strategic business partner from clinical trial development through marketing maintenance phase of a product lifecycle.
- Subject matter expert on FDA codes/regs, guidance, industry standards, complaints/violations, and international codes (EFPIA, IFPMA) with guidelines for global product support.
- Partner with line-management and inform or bring in Head of GRA A&P for complex review concepts/topics.
- Empowered decision-maker within the CMRP.
Qualifications
- Bachelor's Degree in a science-related field required.
- Master's Degree preferred. Minimum of 3 years’ experience in material review and approval process of pharmaceutical/biologics promotion.
- Ability to understand ABPI, EFPIA and other international codes and guidance for prescription medicine advertising and promotion.
- Experience in prescription medicine promotion development and review process.
- Strong interpersonal, strategic, and analytic thinking skills.
- Clear and concise communication; strong written and verbal abilities to manage and drive decisions within teams.
- Negotiation and influencing skills; diplomacy in cross-functional settings.
- Cross-functional people management experience with a collaborative approach.
- Ability to work independently, take initiative, and meet deadlines.
- Previous experience in an advertising and promotion role.
Skills
- Regulatory affairs expertise in advertising and promotion
- Project leadership and global coordination
- Strategic decision-making and stakeholder management
- Communication and negotiation
Education
- Bachelor's Degree in a science-related field
- Master's Degree preferred
Additional Requirements
- Remote work designation; Massachusetts - Virtual location