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Job Description

Mission

Responsible for leading the Medical Affairs team and all medical-scientific activities related to the Therapeutic Area (TA) of Rare Diseases,, including the development of the strategic medical plan for the key brands and supporting the medical /marketing strategies and activities, such as publications, evidence generation, medical education, KOLs engagement, promotional materials and product launchings.  Ensure the appropriate allocation of resources and an excellent execution aligned with the short-, medium- and long-term business goals to boost the TA and company growth.

Accountabilities

• Ensure the development and implementation of robust strategic medical plans for the key brands in the TA under his/her responsibility, aiming at meeting the needs of patients and objectives of the TA  brands/portfolio/pipeline, boosting the company´s growth.
• Ensure the solid relationship with stakeholders, provide high level scientific knowledge through active participation in the Brand Plans and Product Launchings, identifying relevant medical aspects related to the products, providing the medical information appropriately and promptly, and internal scientific training on diseases and products. It also includes teaching classes about the products´ scientific update at scientific events for healthcare professionals, and active participation in meetings with KOLs, Healthcare Organizations (including ANVISA, CEP-CONEP, CONITEC and the Brazilian Ministry of Health, as necessary), Medical Societies, Medical Congresses.
• Together with the Medical Advisors, Product Managers and TA Executive Director, identify potential competitors and design effective strategies to meet the objectives defined for main products, through the excellent implementation of medical /marketing strategies and activities, such as publications, evidence generation, medical education, Key Opinion Leaders (KOLs) engagement, Advisory Boards, Patient Support Program, promotional materials, and product launchings. 
• Be responsible for the medical review and approval of promotional and non-promotional materials, ensuring that the content is based on scientific evidence, well-balanced, and according to the internal and external regulations.
• Approve the screening of KOLs (‘tiering’) following pre-defined criteria.
• Plan and develop protocols of evidence generation/clinical research for products commercially available or under development, working with Global R&D in accordance with internal and external regulations.
• Active participation in Regional and Global Takeda Meetings.
• Provide technical-scientific information to the healthcare professionals, patients, Regulatory, Legal, Ethics & Compliance, Pharmacovigilance, Medical Information, Clinical Development and Business teams, supporting their requests.
• Supervise and provide guidance to Medical/Scientific Managers and MSLs, aiming to achieve a standard of excellence in their activities.

Education, Experiences and Skills

• Graduation in Medicine and Medical Residence;
• Postgraduate in Business, Financial Management, People Management or Team Leadership;
• Proven experience in People Management, Team Leadership and communication skills;
• Proven skills in preparing and implementing Medical Plans and Budget Controlling;
• Knowledge on the Brazilian Health Surveillance Legislation, mainly on product registration, clinical trials and drugs advertising;
• Committed to enhance and embrace Diversity, Equity & Inclusion culture;
• Mandatory: Vast experience in the pharmaceutical industry, including experience as Medical Director or compatible role;
• Desirable: Medical background and/or experience in Rare Diseases (lysosomal storage disease, hereditary angioedema)-Hematology-Citomegalovirus;
• Fluency in Spanish and English.

Specific knowledge 

• Knowledge on statistics, pharmacovigilance, pharmaceutical regulation, Pharmacoeconomics, and Compliance;
• Knowledge on scientific literature search tools and how to read a scientific paper;                                                 
• Strong understanding of the business context, access and regulatory environments, and the trends in the health industry;
• Experience in projects of evidence generation, including the writing of protocols;
• Experience using the key features of the MS Office;
• Strong knowledge on processes in the medical area and related areas, such as Medical Information, Patient Support Program, Medical Management, Consumer Care Center, MSL, Clinical Operations, Pharmacovigilance, and Regulatory;
• Detection of quality issues and development of Corrective Action & Preventive Action (CAPA);
• Experience in supporting Health Authority inspections and auditing processes;
• Experience in partnerships and innovative projects developed with KOLs and medical organizations.

Locations

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