Medical Advisor HAE (Fix-Term contract)

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Job Description

JOB FUNCTION

• Provide medical expertise and support for Therapeutic Area(s) (TAs)/Takeda products with responsibility to Market Access, Brand Management / Marketing & KAMs and other internal stakeholders
• Support the TA Medical Head/Lead and Medical Science Liaisons (MSLs) in establishing the local Medical Strategy Plan and its implementation for the TA of responsibility
• Ensure the correct interpretation and communication of scientific data of Takeda products
• Play a role of advocate for patients needs
• Assist with launch of new products in market

ACCOUNTABILITIES

• Medical/Scientific Affairs
• Continuously screen, review and analyse scientific literature; generate summaries & critical assessments if appropriate
• Present the clinical evidence to internal and external stakeholders in a non-promotional way, e.g. reimbursement bodies, while determining their and patient needs in order to become a partner in improving health care
• Assess scientific accuracy and validity of promotional and non-promotion material and its compliance with Takeda standards, SOPs and national laws
• In collaboration with TA Medical Head /Lead, define, supervises approval process and implement specific medical programs and activities (e.g. medical meetings, disease state education, advisory boards) and associated resource requirements and budgets
• Manage and approve commercial activities according to TA interests and Takeda legal and compliance requirements and policies.
• Communicate and align with Regional and Global Medical Affairs functions, as well as with other LOC functions (e.g. Commercial, Market Access) to ensure alignment in meeting customer needs
• Develop local strategic medical plans in line with product Life Cycle Management plans and oversee execution (including the production of local publications, planning and conduct of local Advisory Board meetings etc.)
• Establish and maintain strong relationships with Key Opinion Leaders (KOLs), understand their needs in order to segment them and create medical strategy and tactics per segment accordingly
• Act as communication link to authors of scientific publications about Takeda products
• Provide extensive, clear and structured briefing to external presenters/speakers at Takeda sponsored medical events, e.g. local Advisory Boards, doctors’ meetings
• Identify gaps in the local clinical study program which are a hurdle for successful regulatory and/or clinical acceptance of the product and propose studies to address these issue
• Provide medical expertise to LOC Market Access, e.g. Pricing & Reimbursement Dossier creation
• Provide medical expertise to LOC Regulatory Affairs/LOC Pharmacovigilance/LOC Quality Assurance
• Evaluate and support local investigator initiated research proposals in alignment with global strategy and Takeda standards and SOPs
• Budget responsibility for medical affairs activities related to TA/product
• Other medical and scientific support duties as assigned
• Provide medical training for allocated therapeutic area / products to Marketing & Sales
• Provide scientific input into Marketing strategy and tactics
• Provide medical input for development of promotion material
• Assess scientific accuracy and validity of promotion material and its compliance with Takeda standards, SOPs and national laws and regulations

CROSS-FUNCTIONAL COLLABORATION

• Ensure awareness and communication of medical activities to other departments within the Local organization
• Participate in local product committees and brand planning cycles; owner of medical part of brand plan

CLINICAL DEVELOPMENT

• Develop study outline and protocol for local post-authorization (phase 4) and other RWE studies sponsored by Takeda; coordinate/oversee study conduct, data analysis and disclosure, reporting/publication
• Liaise with CROs and other vendors for Takeda sponsored global studies as appropriate being able to do supervision to fulfil with regulations regarding local studies.
• Collaborate with Global Development Operations functions (e.g. LOC Support)

MEDICAL INFORMATION

• Provide timely, accurate and balanced answers to unsolicited medical enquiries
• Collaborate with Regional and Global Medical Information

OTHERS

• Promote, encourage and demonstrate commitment to Takeda-ism philosophy and values
• Communicate any adverse reaction as soon as it is identified to the Pharmacovigilance Department as detailed in the company’s internal procedures
• Act according to Corporate, Compliance, Ethical codes and Legal standards.

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