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Medical affairs manager gi/inflammation

Roma
Bitrock
Pubblicato il 26 gennaio
Descrizione

PpRoma /ppEUR 90.000 - 110.000 /ph3Job Description /h3h3OBJECTIVES /h3ullibStrategic Contribution /b: Provide medical expertise to shape and execute Takeda’s strategy for Gastrointestinal/Inflammation Therapeutic Area and pipeline products (NPP) by collaborating cross-functionally. /lilibScientific Leadership /b: Offer in-depth scientific insights to ensure alignment with evidence-based medicine for product development, launch, and lifecycle activities. /lilibStakeholder Engagement /b: Strengthen relationships with key opinion leaders (KOLs), healthcare professionals (HCPs), and scientific communities to support medical strategies and advance therapeutic understanding. /lilibEvidence Generation /b: generate new clinical data and scientific evidence to support both in line/pipeline assets /lilibCompliance and Training /b: Advocate medical compliance to maintain high ethical standards and provide scientific training to internal teams (BUs and PVA) to elevate internal capabilities (scientific updates, newsletters, congress reports). /li /ulh3ACCOUNTABILITIES /h3ullibMedical Expertise Strategy /b: Support medical strategies development and medical plans implementation across the GI portfolio to align with Takeda’s overall business objectives. /lilibScientific Support /b: Provide medical and scientific input into clinical development plans while ensuring adherence to ethical and regulatory standards. /lilibStakeholder Engagement /b: Build and maintain relationships with key opinion leaders (KOLs), key external experts (KEEs), DOLs (Digital Opinion Leaders), healthcare providers and academic researchers to drive awareness and credibility in GI/Inflammation TA. /lilibPipeline /b: provide support to cross-functional launch readiness: pre-launch medical strategy, stakeholder mapping engagement plan, insight generation, evidence generation, scientific narrative materials readiness, medical education training, congresses, advisory boards expert meetings. /lilibMedical Education /b: Plan and deliver scientific training and educational programs for internal teams (e.g. Commercial and PVA) to ensure understanding/alignment on both products and therapeutic areas GI and Inflammation. /lilibDisclosure Communication /b: Manage external communication of scientific data, including presentations at conferences, advisory boards and other scientific platforms. /lilibCross-Functional Collaboration /b: Partner with marketing, regulatory, PVA and commercial teams to provide medical input to co-create strategies and effectively achieve GI Inflammation TAs objectives. /lilibEvidence Generation /b: Collaborate on real-world evidence generation, RD clinical trials (active participation in the Global Enterprise Engagement Project) and publication strategies to support Takeda’s product lifecycle management. Discuss and collect independent research proposals (IIRs) according to the company guidelines and related SOPs. /lilibProduct Launch Activities /b: Provide guidance in the preparation and execution of product launches by delivering medical and scientific support while ensuring compliance with industry standards. /lilibPVA support: /b Coordinate with PVA teams both for JCA activities, product dossier submissions, providing scientific expertise and scientific documentation to ensure successful outcomes. /lilibRegulatory support /b: coordinate with the regulatory team to ensure support to regulatory activities. /lilibBudget /b: support budget management allocated to medical projects and congresses delegations according to TA medical plans and congress plans. /li /ulh3EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS /h3h3Education and experience /h3ulliEducation requirements: Medical Degree (MD); PharmD or PhD. /liliMore than 3 years of experience in medical affairs roles. /liliGood written and spoken English (minimum level required: Intermediate B1). /li /ulh3Knowledge of /h3ulliBasic knowledge of pharma industry legislation /liliDrug Development and Marketing processes and requirements /liliClinical research regulatory environment, including but not limited to ICH GCP and Dir 536/2014 /li /ulh3Technical skills /h3ulliAbility to engage with KOL community based on existing strong relationships and ability to build lasting relationships with KOLs. /liliThorough understanding of life cycle management. /liliExperience with working in pre-launch phase and launch preparation. /liliAbility to interpret and communicate scientific/ clinical data and collect/interpret/sharing insights. /li /ulh3Digital Dexterity skills /h3pDemonstrate strong digital dexterity to amplify Medical Affairs impact using digital channels, data, and compliant technology to improve stakeholder engagement, insight generation, evidence generation, and internal scientific enablement, while ensuring privacy, security and ethical standards. /pulliEffectively plan and deliver scientific exchange via compliant digital channels (e.g., remote detailing platforms, virtual advisory boards, webinars, congress digital assets). /liliAdapt communication style and content to channel and stakeholder needs, maintaining scientific accuracy and balance. /liliUse digital tools to capture, structure, and synthesize stakeholder insights (e.g., tagging, qualitative coding, trend analysis) and translate them into actionable recommendations. /li /ulh3Content knowledge management /h3ulliDevelop and maintain modular scientific content and repositories (e.g., core slide decks, FAQs, congress learnings, newsletters) with clear version control and traceability. /li /ulh3AI literacy and practical application (within policy) /h3ulliIdentify high-value use cases for AI-enabled solutions in Medical Affairs (e.g., literature monitoring, summarization support, insight triage, workflow automation) while adhering to Takeda policies and approved tools. /liliDemonstrate ability to evaluate AI outputs critically (citation checking, scientific rigor) and escalate uncertainties appropriately. /li /ulh3Compliance, privacy, and cybersecurity /h3ulliEnsure compliant handling of scientific information and stakeholder data in all digital interactions, in line with internal SOPs, data privacy requirements and security standards. /li /ulh3Continuous learning change adoption /h3ulliProactively upskill on emerging digital platforms, field tools, and ways of working; share best practices to encourage adoption across the team. /liliDemonstrate agility in adopting new processes and tools that improve execution speed, quality and collaboration. /liliStrong business acumen. /liliProactive and positive work ethic. /liliAbility to operate as a flexible team player. /liliAbility to work in a cross-functional team and evidence of building cross-region networks. /li /ulh3Other /h3ulliThe role will involve both national and international travel. /li /ul /p #J-18808-Ljbffr

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