GLOBAL MEDICAL OPERATIONS MANAGER
13 days ago
Barcelona
GLOBAL MEDICAL OPERATIONS MANAGERPassa a contenuto principale Siga leyendo para comprender completamente lo que este trabajo requiere en cuanto a habilidades y experiencia. Si su perfil encaja, presente su candidatura. **Questo sito web utilizza cookie Questo sito web utilizza cookie propri e di terzi allo scopo di offrire funzionalità di social network e ricavare statistiche. Puoi impostare le tue preferenze per rifiutare o accettare i cookie qui. Per ulteriori informazioni, consulta la nostra Politica sui cookie.# Lavora con noiGLOBAL MEDICAL OPERATIONS MANAGER page is loaded## GLOBAL MEDICAL OPERATIONS MANAGERPresenta candidaturaremote type: R&D & Medical Affairslocations: BARCELONAtime type: Full timeposted on: Offerta pubblicata oggijob requisition id: 001556Stiamo costruendo il futuro della dermatologia medica concentrandoci sui bisogni ancora insoddisfatti dei pazienti e dando alle persone lo spazio per pensare in modo indipendente, assumersi responsabilità e generare un impatto che conta davvero.Il nostro purpose è semplice: trasformare la vita dei pazienti rispondendo a bisogni reali. Lavoriamo con rigore, agiamo con coraggio, teniamo le cose semplici e orientiamo l’innovazione dove può davvero fare la differenza.Riconosciuti come Top Employer in Spagna dal 2008 e in Germania dal 2025, continuiamo a investire in un ambiente in cui le persone possono crescere e andare avanti.Se pensi in modo diverso, qui è il posto giusto per te. **Mission **The Global Medical Operations Manager is responsible for the operational planning, coordination, and oversight of Global Medical Affairs studies, with a strong focus on Investigator-Initiated Studies (IIS), Phase IV / non-interventional studies, and Real-World Evidence (RWE) initiatives.The role ensures end-to-end operational excellence, compliance, transparency, and cross-functional alignment across global and local teams, enabling timely evidence generation to support Global Medical strategy. **Key Responsibilities 1. Investigator-Initiated Studies (IIS) & Global Medical Grants Management **Act as the **global operational owner for IIS and selected global medical grants: • Serve as primary operational point of contact for globally supported IIS, • Coordinate IIS activities across Legal, Compliance, Finance, Clinical Trial Supply, R&D, IP, CROs, global and local teams, • Lead and coordinate: + Contract generation and execution with HCPs/HCOs + Amendment management in collaboration with Legal and affiliates + Budget monitoring and reporting, • Maintain global IIS master documentation, including: + Proposals and approvals + Agreements and amendments + Invoice tracking and payment documentation + Final report/publication tracking (links or references, as applicable), • Track study progress, milestones, and deliverables in collaboration with affiliates, • Manage the full invoice and payment lifecycle, ensuring timely and accurate processing, • Ensure transparency reporting for global IIS and grants in applicable systems (e.g. Veeva), in line with local legislation (with particular attention to high-complexity markets such as France and the US) • Provide quarterly IIS KPI reporting in line with Global Medical Affairs guidance, • Support pharmacovigilance requirements by ensuring IIS operational data is available for PSUR, DSUR, and PSMF activities (upon request and per SOP) **2. Global Phase IV, RWE, and Non-Interventional Studies **Provide operational experience and support for Global Medical evidence generation initiatives, including RWE: • Support the planning, execution, and oversight of company-sponsored Phase IV, low-interventional, and non-interventional studies, • Act as the main operational contact for CROs, ensuring quality, timelines, and budget adherence, • Support Global Medical Leads in delivering evidence aligned with Brand Plans and Medical Strategy, • Track and maintain an overview of globally sponsored and locally executed GMA studies, ensuring visibility, consistency, and governance, • Maintain accurate and timely study updates to support: + Pharmacovigilance reporting + Public registry disclosure obligations + Internal governance and decision-making forums **3. Cross-Functional Governance & Stakeholder Engagement * Actively participate in Phase IV / IIS Review Committee when IIS proposals are presented and discussed • Coordinate follow-up actions after IIS approval and ensure alignment across stakeholders, • Collaborate closely with: + Global and Local Medical Affairs teams + Finance (budget tracking and long-term projections) + Global Compliance and QA + Legal (for contracts) + CRO partners and external vendors, • Contribute to medical operations updates, including internal communication updates, enabling informed decisions within Global Medical Affairs, • Attend selected scientific meetings, operational forums, and internal trainings as relevant to role scope **4. Process Optimization, SOP Ownership & Digital Innovation * Lead the review, update, and implementation of key Medical Operations SOPs related to studies • Maintain and update the Medical Operations Hub and study-specific operational pages, ensuring accuracy, relevance, and alignment with Global Medical needs, • Proactively identify opportunities for digital solutions and emerging technologies (e.g., workflow automation, analytics, AI-assisted processes) xcskxlj to improve efficiency and data quality in studies management **Education * University degree in **Pharmacy, Biology, Chemistry, Life Sciences , or equivalent **Experience * Proven experience in: + Clinical operations, medical operations, or study management + Phase IV, non-interventional, or RWE studies + Cross-functional coordination in a global matrix environment • Solid understanding of: + Transparency and compliance requirements + Study governance and lifecycle management, • Experience in Dermatology or related therapeutic areas is an asset, • Fluent in English (written and spoken) **Competencies & Values * Operational Excellence: Structured, detail-oriented, and delivery-focused • **Collaboration: Able to work effectively across functions, cultures, and geographies • **Ownership & Accountability: Takes responsibility for global activities and outcomes • **Innovation & Simplicity: Seeks practical solutions and continuous improvement • **Patient-Centric Mindset: Keeps scientific integrity and patient impact at the core **Our Values * Care – We listen, empathize, and support each other • **Courage – We challenge the status quo and take ownership • **Innovation – We create meaningful, patient-centered solutions • **Simplicity – We act decisively and keep things clear and effective### La nostra ambizione è chiaraStiamo costruendo il futuro della dermatologia medica concentrandoci sui bisogni ancora insoddisfatti dei pazienti e dando alle persone lo spazio per pensare in modo indipendente, assumersi responsabilità e generare un impatto che conta davvero.Se pensi in modo diverso, qui è il posto giusto per te. #J-18808-Ljbffr