Associate Director - Global Medical Information & Review, EUCAN

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Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.

Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

About the role:

The Associate Director, Medical Information and Review, EUCAN will serve as a functional expert in the area of primarily Medical Review and Medical Information for their assigned products in EUCAN and ensure alignment with regional and local regulations, enable integration of process and technology efficiencies in medical review activities for both promotional and non-promotional materials across therapeutic areas for Global Medical Affairs Oncology (GMAO).

The primary focus of the candidate in this position will be to partner with the Head of Medical information and Review on the implementation of global processes, systems and vendors as needed. The individual in this role must excel in providing advanced medical and scientific review of promotional and promotional materials with local and regional Regulatory codes applicable for the EUCAN region in mind. Experience with the ABPI, EFPIA, (FDA), Swissmedic and EMEA codes is critical for this role. The individual will also support the non-promotional and promotional review process optimization across GMAO and commercial functions as needed.

The individual in this role will be responsible for performing timely, accurate and detailed scientific/medical review of non-promotional and promotional materials 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, the individual in this role might 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, health care professionals (HCPs) and consumers. 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) and external stakeholders (eg, HCPs, patients and advocacy groups).

Lastly, this individual may be required to support Medical Information and Review needs and activities for other brands and pipeline products, as well as above brand activities, to ensure a best in class Medical Information and Review function, ensuring 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:

• Provide advanced medical and scientific review of medical affairs materials and, if required, promotional materials to support non-promotional and promotional review processes, as well as providing project management support for the medical review process, as needed.
• 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.
• Responsible for scientific information contained in Takeda’s EUCAN and Global promotional and non-promotional materials (eg, medical communication materials, training materials, and advisory board materials) is accurate, not misleading and is medically relevant.
• Anticipate and recognize when to escalate to manager/medical team to resolve higher risk or complex issues.
• Understand that recommendations, actions and decisions made for promotional materials are critical in ensuring compliance with applicable regulatory/practice standards pertinent to the promotion of pharmaceutical products.
• Utilizing advanced medical information /clinical expertise, independently oversee, plan, develop, maintain and provide high-quality, balanced and timely medical and scientific information deliverables including Standard and Custom Response Letters, Global Core Response Documents, Clinical Dossiers, and FAQs, to both internal and external customers.
• Provide guidance and direction 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.
• 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.
• 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 Information and 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 and inform medical strategies by disseminating actionable medical insights and trends on a consistent basis. Lead the development and maintenance of departmental procedural guidelines and SOPs.
• Coach and mentor interns, fellows, students and Medical Information & Review team members.

Minimum Requirements/Qualifications:

• The qualified candidate should have an advanced degree (PhD, PharmD or equivalent) in a scientific discipline (preferred) or a minimum of Bachelor’s degree in a scientific discipline 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 information and review experience within the pharmaceutical industry
• Excellent written and oral communication skills
• Advanced PC skills, including MS Word, Excel, Power Point, and SharePoint
• Experience overseeing and managing budgets to ensure performance versus targets
• Oncology experience strongly preferred
• Firm understanding of pharmaceutical clinical development and product life cycle management
• Cross-functional team participation within the pharmaceutical or related industry

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

Learn more at takedajobs.com

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