Medical Affairs Manager Gi/Inflammation

OverviewMedical Affairs Manager GI/Inflammation – Takeda, Rome, Italy ObjectivesStrategic Contribution : Provide medical expertise to shape and execute Takeda's strategy for Gastrointestinal/Inflammation Therapeutic Area and pipeline products (NPP) by collaborating cross-functionally.Scientific Leadership : Offer in-depth scientific insights to ensure alignment with evidence-based medicine for product development, launch, and lifecycle activities.Stakeholder Engagement : Strengthen relationships with key opinion leaders (KOLs), healthcare professionals (HCPs), and scientific communities to support medical strategies and advance therapeutic understanding.Evidence Generation : Generate new clinical data and scientific evidence to support both in-line/pipeline assets.Compliance and Training : 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).AccountabilitiesMedical Expertise & Strategy : Support medical strategies development and medical plans implementation across the GI portfolio to align with Takeda's overall business objectives.Scientific Support : Provide medical and scientific input into clinical development plans while ensuring adherence to ethical and regulatory standards.Stakeholder Engagement : Build and maintain relationships with KOLs, KEEs, DOLs (Digital Opinion Leaders), healthcare providers and academic researchers to drive awareness and credibility in GI/Inflammation TA.Pipeline : 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.Medical Education : 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.Disclosure & Communication : Manage external communication of scientific data, including presentations at conferences, advisory boards and other scientific platforms.Cross-Functional Collaboration : Partner with marketing, regulatory, PVA and commercial teams to provide medical input to co-create strategies and effectively achieve GI & Inflammation TAs objectives.Evidence Generation : Collaborate on real-world evidence generation, R&D 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 company guidelines and related SOPs.Product Launch Activities : Provide guidance in the preparation and execution of product launches by delivering medical and scientific support while ensuring compliance with industry standards.PVA Support : Coordinate with PVA teams for JCA activities, product dossier submissions, providing scientific expertise and scientific documentation to ensure successful outcomes.Regulatory Support : Coordinate with the regulatory team to support regulatory activities.Budget : Support budget management allocated to medical projects and congresses delegations according to TA medical plans and congress plans.Education, Behavioural Competencies & SkillsEducation and Experience : Medical Degree (MD); PharmD or PhD.More than 3 years of experience in medical affairs roles.Good written and spoken English (minimum level required: Intermediate B1).Knowledge : Basic knowledge of pharma industry legislation; Drug Development and Marketing processes and requirements; Clinical research regulatory environment, including ICH GCP and Dir ********.Technical Skills : Ability to engage with KOLs and build lasting relationships; thorough understanding of lifecycle management; experience in pre-launch phase and launch preparation; ability to interpret and communicate scientific/clinical data and collect/interpret/share insights.Digital Dexterity : Demonstrate strong digital dexterity to amplify Medical Affairs impact using digital channels, data, and compliant technology to improve stakeholder engagement, insight generation, and internal scientific enablement, while ensuring privacy, security and ethical standards.Digital Engagement & Omnichannel ExecutionPlan and deliver scientific exchange via compliant digital channels (remote detailing platforms, virtual advisory boards, webinars, congress digital assets).Adapt communication style and content to channel and stakeholder needs, maintaining scientific accuracy and balance.Data Literacy & Insight GenerationUse digital tools to capture, structure, and synthesize stakeholder insights and translate them into actionable recommendations.Content & Knowledge ManagementDevelop and maintain modular scientific content and repositories with version control and traceability.AI Literacy & Practical ApplicationIdentify high-value use cases for AI-enabled solutions in Medical Affairs while adhering to Takeda policies and approved tools; evaluate AI outputs critically and escalate uncertainties appropriately.Compliance, Privacy, & CybersecurityEnsure compliant handling of scientific information and stakeholder data in all digital interactions, in line with SOPs, data privacy requirements and security standards.Continuous Learning & Change AdoptionUpskill on emerging digital platforms and tools; share best practices; demonstrate agility in adopting new processes to improve execution speed, quality and collaboration.Soft SkillsStrong business acumen; proactive and positive work ethic; flexible team player; ability to work in cross-functional teams and build cross-region networks.OtherThe role will involve national and international travel.Valid and clean driver's license.Locations : Rome, ItalyWorker Type : EmployeeTime Type : Full time#J-*****-Ljbffr