About the Role
The Associate Director, Medical Information and Review for EUCAN will act as a functional expert primarily in the areas of Medical Review and Medical Information for their assigned products. This role ensures alignment with regional and local regulations and facilitates the integration of process and technology efficiencies in medical review activities for both promotional and non-promotional materials across therapeutic areas within Global Medical Affairs Oncology (GMAO).
The successful candidate will collaborate closely with the Head of Medical Information and Review to implement global processes, systems, and vendors as required. This position demands excellence in the advanced medical and scientific review of promotional and non-promotional materials, underpinned by local and regional regulatory codes applicable to the EUCAN region. Proficiency with ABPI, EFPIA, FDA, Swissmedic, and EMEA codes is essential. Additionally, the individual will support optimization in the review process for both non-promotional and promotional materials across GMAO and commercial functions.
Key responsibilities include conducting timely, accurate, and detailed scientific and medical reviews of materials, ensuring compliance with established policies and regulatory guidelines, and conveying precise and balanced medical and scientific messages in Takeda’s promotional and non-promotional materials.
Moreover, the Associate Director may be tasked with planning and delivering high-quality, balanced, and prompt medical and scientific information deliverables for assigned products upon request from internal and external partners, healthcare professionals, and consumers. They will provide advanced medical information and clinical expertise to internal stakeholders such as medical affairs strategy teams and product teams, as well as external stakeholders like healthcare professionals and patient advocacy groups.
This individual may also support the Medical Information and Review needs for other brands and pipeline products, facilitating top-tier Medical Information and Review functions and upholding Takeda Oncology’s reputation and integrity through high-quality medical information and communication.
How You Will Contribute
- Provide advanced medical and scientific review of medical affairs materials and promotional materials to support non-promotional and promotional review processes, including project management support as necessary.
- Ensure content is well-established by scientific data, verifying citations, checking the authenticity of references, and ensuring that promotional claims are supported in context.
- Oversee the scientific accuracy of Takeda’s EUCAN and Global promotional and non-promotional materials, ensuring they are medically relevant and not misleading.
- Recognize when to escalate higher-risk or complex issues to the manager or medical team.
- Understand that decisions regarding promotional materials are crucial for compliance with relevant regulatory standards.
- Utilize advanced medical information and clinical expertise to independently produce high-quality medical and scientific information deliverables, including Standard and Custom Response Letters and Clinical Dossiers.
- Guide the Medical Information Call Center staff in handling routine and complex cases and manage escalated cases as necessary.
- Develop and deliver Medical Information training to ensure compliance with internal policies and procedures.
- Collaborate with GMAO stakeholders to create content for the medical affairs booth and support product booths at scientific meetings and congresses.
- Act as the Medical Information and Review subject matter expert during Global Medical Strategy Team Oncology meetings.
- Design and implement internal communication plans to disseminate actionable medical insights and trends consistently.
- Coach and mentor interns, fellows, students, and team members in Medical Information and Review.
Minimum Requirements/Qualifications
- An advanced degree (PhD, PharmD, or equivalent) in a scientific discipline is preferred, or a Bachelor's degree in a scientific discipline with substantial experience in the pharmaceutical or biotech industry.
- A minimum of 5 years of healthcare or related experience, including at least 3 years in medical information and review within the pharmaceutical industry.
- Excellent written and oral communication skills.
- Proficiency in MS Word, Excel, PowerPoint, and SharePoint.
- Experience in budget management to ensure performance meets targets.
- Experience in oncology is strongly preferred.
- A comprehensive understanding of pharmaceutical clinical development and product lifecycle management.
- Team participation experience in cross-functional settings within the pharmaceutical or related industries.
To apply, apply online using the form below. Only applications matching the job profile will be considered.