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Job Description

About the role:

The Associate Director, Medical Review, will serve as a functional expert in the area of Medical Review for their assigned region and products and ensure alignment and integration of process and technology efficiencies in medical review activities across diseases areas for Global Medical Affairs Oncology (GMAO).

The individual in this role must excel in providing advanced medical and scientific review of commerical and medical affairs materials (promotional and non promotional materials) to support the non-promotional and promotional review processes. The Individual in this role will be responsible for performing timely, accurate and detailed scientific/medical review of non-promotional and promotional materials for the US and Global market in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs. He/she ensures Takeda non-promotional/ promotional materials convey accurate, correct and balanced medical/ scientific messages.

In addition, will be required to partner with the Head of Medical Review to deliver as needed high-quality, balanced and timely medical and scientific information deliverables for assigned products upon request from internal business partners. They must provide advanced medical information / clinical expertise for assigned products to internal stakeholders (eg, medical affairs strategy teams, product teams within R&D, commercial Brand teams).

Lastly, this individual may be required to support Medical Review needs and activities for other brands and pipeline products, as well as above brand activities, to ensure a best in class Medical Review function, ensuring Takeda Oncology’s professional standing and integrity with patients, HCPs and the pharmaceutical industry through high-quality and aligned medical 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, as well as providing project management support for the medical review process, as needed.

• Provide advanced medical and scientific review of promotional and promotional materials with local and regional Regulatory codes applicable for the US region in mind. Experience with the ABPI, EFPIA, and EMEA codes is optional but preferred for this role.

• Develop and deliver ongoing Medical Review and MLR process training for internal groups and medical affairs teams to ensure compliance with policies and procedures.

• Ensure content is well-substantiated by scientific data (verifying the content is accurately cited/properly referenced); check authenticity and validity of references; determine that references in promotional materials specifically support product claims made in the material; and ensure the context of the reference is appropriately reflected in the promotional claim(s) in the material.

• Develop content for the medical affairs booth in collaboration with GMAO stakeholders, as well as supporting third-party vendors. Provide advanced support to product booths at professional scientific meetings and congresses as appropriate. Participate in booth design and congress activities as required.

• Serve as the Medical Review subject matter expert on the Global Medical Strategy Team Oncology (GMSTO) meetings for the relevant products/ therapeutic areas.

• Design and implement internal communication plans to share metrics 

• Lead the development and maintenance of departmental procedural guidelines and SOPs.

• Coach and mentor interns, fellows, students and Medical Review team members.

Minimum Requirements/Qualifications:

• PharmD/Doctorate with 5+ years of experience, OR, Masters degree in a scientific discipline with 7+ years of experience, OR Bachelor’s degree in a scientific discipline with 8+ years of experience, all plus commensurate long-term experience within pharmaceutical or biotech industry with a thorough grasp of the pharmaceutical industry

• 5+ years of healthcare or related experience (managed markets, clinical practice, research or academic) including 3+ years of medical review experience within the pharmaceutica