Director, eCOA Licensing and Localization

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🕒 Julho 21

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $149.805 - $196.620 / ano

⏰ Tempo Integral

🔴 Especialista

🌎 Tradutor(a) / Intérprete

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AstraZeneca

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1999

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 Post-IPO Debt em 2023-02

Healthcare • Biotechnology • Pharmaceuticals

AstraZeneca é uma empresa biofarmacêutica global, orientada pela ciência, que se concentra na descoberta, desenvolvimento e comercialização de medicamentos de prescrição. Atua principalmente nas áreas de oncologia, cardiovascular, renal e metabolismo e doenças respiratórias. Com operações em mais de 100 países, a AstraZeneca é dedicada à pesquisa científica e ao compromisso de fornecer tratamentos eficazes e melhorar a saúde dos pacientes em uma ampla gama de condições.

Descrição

• Own the day-to-day management of the teams across the eCOA shared services domain, including resourcing, workload prioritization, performance management, coaching, and career development. • Build a high-performing, collaborative culture focused on quality and continuous improvement. • Maintain hands-on fluency with eCOA/ePRO build and configuration, and own the end-to-end instrument licensing process, including intake, ownership identification, fee tracking, and copyright approvals across a global study portfolio. • Establish and run Evinova's licensing function on a study-by-study basis, owning and growing commercial relationships with instrument licensing partners, negotiating terms and resolving escalations directly. • Own the end-to-end multilingual localization workflow for studies, from scoping language requirements by country through translation, linguistic validation (LV), and deployment-ready sign-off. • Own and grow Evinova's commercial relationships with translation and localization partners, setting service expectations and managing performance against agreed timelines and quality standards. • Own the process, quality, and production of screenshot packages across source language and all localized versions, ensuring version-controlled archives remain audit-ready and suitable for regulatory submission. • Partner closely with the Product team to shape the tooling that supports eCOA build and configuration, screenshot production, and translation/localization workflows. • Partner with the Sales/Commercial team to support feasibility assessments for new and prospective studies, providing clear, timely guidance on licensing timelines, localization scope, and delivery feasibility to support accurate scoping, proposals, and customer commitments. • Act as Evinova's senior eCOA subject matter expert in sponsor- and CRO-facing forums, including senior governance and escalation discussions, translating complex requirements into clear delivery commitments. • Determine team priorities in alignment with portfolio and business needs, and allocate resources to meet delivery commitments and quality standards across a growing book of work. • Identify opportunities to improve eCOA licensing, localization, and screenshot processes, and drive adoption of best practices and reuse across the team. • Proactively identify licensing, localization, and screenshot risks across the team's portfolio of studies (e.g., late licences, unexpected language scope, LV gaps) and put mitigation plans in place through the project RAID framework. • Establish and maintain reporting on team performance, delivery progress, and quality, and use it to inform decisions on resourcing and prioritization. • Represent the eCOA shared services function in discussions with Delivery leadership, Product, and Commercial, and act as a key partner in shaping strategy across those functions.

🎯 Requisitos

• eCOA Vendor Experience: Must have prior experience in an equivalent role at another eCOA vendor, owning the same end-to-end eCOA licensing and localization function. • Instrument Licensing Expertise: Must have extensive, hands-on experience across the full range of eCOA/ePRO instrument types and licensing models, with a demonstrated ability to build and run a licensing function or service from the ground up. • Localization at Scale: Must have deep experience managing eCOA localization at scale — multilingual builds, translation vendor relationships, linguistic validation evidence, and language-specific instrument license approvals. • Independent Problem-Solving: Must be able to operate independently amid ambiguity and competing priorities across licensing, localization, and delivery timelines, driving issues to resolution without needing significant direction, and staying effective and level-headed when the path forward isn't clear-cut. • Proven experience leading and managing multi-disciplinary teams responsible for eCOA configuration, licensing, localization, and/or screenshot production, including resourcing and prioritization at a portfolio level. • Track record owning commercial relationships with licensing and/or translation partners, including negotiation and performance management. • Senior, direct customer-facing experience in a clinical technology delivery environment — comfortable leading sponsor and CRO governance discussions and representing the business as an external SME. • Strong command of eCOA/ePRO instrument licensing and copyright requirements, including instrument owner screenshot review and approval processes. • Experience partnering with Sales/Commercial teams on licensing and delivery feasibility, scoping, or pre-sales support for new studies.

🏖️ Benefícios

• short-term incentive bonus opportunity • eligibility to participate in our equity-based long-term incentive program • qualified retirement program [401(k) plan] • paid vacation and holidays • paid leaves • health benefits including medical, prescription drug, dental, and vision coverage