24 oct
|
Almirall
|
Barcelona
24 oct
Almirall
Barcelona
GLOBAL MEDICAL OPERATIONS MANAGERPassa a contenuto principaleQuesto 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.MissionThe 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 ManagementAct 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 General 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 StudiesProvide 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 forums3. 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 scope4. 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, ensur
📌 GLOBAL MEDICAL OPERATIONS MANAGER (Barcelona)
🏢 Almirall
📍 Barcelona