About the Role
The Associate Director, Medical Information and Review, EUCAN will serve as a functional expert in Medical Review and Medical Information for assigned products in the EUCAN region. This role is crucial in ensuring alignment with regional and local regulations, while promoting seamless integration of processes and technological efficiencies in medical review activities for both promotional and non-promotional materials across therapeutic areas in Global Medical Affairs Oncology (GMAO).
The primary focus will be to collaborate with the Head of Medical Information and Review on the implementation of global processes, systems, and vendors. The successful candidate must excel in providing comprehensive medical and scientific reviews of promotional and non-promotional materials, keeping local and regional regulatory codes applicable to the EUCAN region in mind. Experience with ABPI, EFPIA, FDA, Swissmedic, and EMEA codes is critical for this position. Additionally, the candidate will support the optimization of the review process across GMAO and commercial functions as needed.
In this role, you will be responsible for performing timely, accurate, and detail-oriented scientific/medical reviews of materials, adhering to established policies and practice standards, including regulatory guidelines to meet customer needs. You will ensure that Takeda’s non-promotional and promotional materials convey accurate, balanced medical and scientific messages.
The Associate Director may also be required to plan and deliver high-quality, balanced, and timely medical and scientific information deliverables for assigned products upon request from internal and external business partners, healthcare professionals (HCPs), and consumers. You will provide advanced medical information and clinical expertise for assigned products to both internal stakeholders (e.g., medical affairs strategy teams, product teams within R&D, commercial brand teams) and external stakeholders (e.g., HCPs, patients, and advocacy groups).
Finally, this individual may support Medical Information and Review needs for other brands and pipeline products as well as above-brand activities, ensuring a best-in-class Medical Information and Review function. This commitment reinforces Takeda Oncology’s professional standing and integrity with patients, HCPs, and the pharmaceutical industry through high-quality and aligned medical information and communication.
How You Will Contribute
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Provide advanced medical and scientific review of medical affairs materials and promotional materials to support non-promotional and promotional review processes, along with project management support for the medical review process as needed.
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Ensure content is well-substantiated by scientific data, verifying that references are accurately cited and properly referenced; check the authenticity and validity of references; confirm that references in promotional materials specifically support product claims and ensure the context of the reference is appropriately reflected in the promotional claims.
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Ensure scientific information in Takeda’s EUCAN and Global promotional and non-promotional materials (e.g., medical communication materials, training materials, advisory board materials) is accurate, not misleading, and medically relevant.
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Anticipate and recognize when to escalate issues to the manager or medical team to resolve complex matters.
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Understand that recommendations, actions, and decisions regarding promotional materials are critical for ensuring compliance with applicable regulatory and practice standards related to the promotion of pharmaceutical products.
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Utilize advanced medical information and clinical expertise to independently oversee, plan, develop, maintain, and deliver high-quality, balanced, and timely medical and scientific information deliverables, including Standard and Custom Response Letters, Global Core Response Documents, Clinical Dossiers, and FAQs.
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Provide guidance to the Medical Information Call Center staff on handling routine and complex cases; monitor and manage complex escalated cases from the Medical Information Contact Center.
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Develop and deliver ongoing Medical Information training for internal groups, Contact Center personnel, medical affairs teams, and sales groups to ensure compliance with Medical Information policies and procedures.
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Collaborate with GMAO stakeholders to develop content for the medical affairs booth and provide support for product booths at professional scientific meetings and congresses as necessary.
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Serve as the Medical Information and Review subject matter expert in Global Medical Strategy Team Oncology (GMSTO) meetings for relevant products and therapeutic areas.
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Design and implement internal communication plans to share metrics and inform medical strategies, disseminating actionable medical insights and trends consistently. Lead the development and maintenance of departmental procedural guidelines and SOPs.
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Coach and mentor interns, fellows, students, and Medical Information & Review team members.
Minimum Requirements/Qualifications
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Advanced degree (PhD, PharmD or equivalent) in a scientific discipline preferred; or a Bachelor's degree in a scientific discipline plus significant experience in the pharmaceutical or biotech industry with a thorough understanding of the pharmaceutical industry.
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5+ years of healthcare or related experience (managed markets, clinical practice, research, or academic), including 3+ years of medical information and review experience within the pharmaceutical industry.
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Excellent written and oral communication skills.
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Advanced PC skills, including MS Word, Excel, PowerPoint, and SharePoint.
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Experience in overseeing and managing budgets to ensure performance against targets.
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Oncology experience strongly preferred.
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Firm understanding of pharmaceutical clinical development and product life cycle management.
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Cross-functional team participation within the pharmaceutical or related industry.
Apply online using the form below. Only applications matching the job profile will be considered.