Senior Translations Project Manager – Regulatory submissions Pharma

hace 1 mes

Quito IQVIA Full time

Department: Language Services
Specialization: Regulatory Submissions (Marketing Authorization)
Location: Hybrid (Argentina, Latam and/or Canada)
Employment Type: Full time

Role Purpose

As part of IQVIA's Project Management team, you will coordinate and manage the full lifecycle of Regulatory Submissions translation and localization projects for Marketing Authorization, ensuring IQVIA's quality standards and timely delivery.

Key Responsibilities

  • Manage multiple Regulatory Submissions translation/localization projects from receipt to completion.

  • Serve as the primary point of contact for internal and external clients, handling requirements, escalations, and issues.

  • Manage client accounts, assign projects within the PM team, and ensure client expectations are met.

  • Assess project scope, select appropriate vendors, and negotiate deadlines effectively.

  • Build and maintain strong relationships with freelance and in-house linguists worldwide.

  • Monitor project status to anticipate and prevent issues proactively.

  • Handle project finances, including accurate quoting and budgeting.

  • Prepare and maintain project documentation and ensure compliance with IQVIA SOPs and Quality Management System.

  • Support training and development of junior staff in collaboration with Team Leads.

  • Assist in maintaining linguistic assets (glossaries, style guides).

  • Ensure high-quality standards through QA checks.

  • Provide weekend coverage when required by project timelines.

  • Prepare and follow up on quotations.

Requirements

  • Minimum 4 years of experience in Project Management within the Language Services industry.

  • Expertise in Regulatory Submissions / Marketing Authorization projects; experience with FDA, APAC, LATAM, MENA, and/or Canada submissions is highly desirable.

  • Proven experience managing client accounts and acting as the key point of contact.

  • Advanced client relationship management skills with ability to develop new partnerships.

  • Bachelor's degree, ideally in linguistics, business, or a scientific field.

  • Fluent English (additional languages are a plus).

  • Excellent written and verbal communication skills and attention to detail.

  • Ability to meet strict deadlines, manage competing priorities, and adapt to changing demands.

  • Strong problem-solving and analytical skills.

  • Ability to work independently while using initiative.

  • Advanced IT skills; experience with TMS and CAT tools (XTRF and/or memoQ highly advantageous).

  • Ability to build and maintain effective relationships with colleagues, managers, and clients.

#Localization Project Manager

#Translation Project Manager

#Marketing Authorization

#CTD (Common Technical Dossier)

#QRD templates, SmPC (Summary of Product Characteristics)

#PIL (Package Leaflet/Patient Information Leaflet), Labelling

#NDA, Premarket Approval (PMA)

#Marketing Authorization Application (MAA)

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

  • Senior Translations Project Manager – Regulatory submissions Pharma

    hace 1 mes

    Quito IQVIA Full time

    As part of IQVIA's Project Management team, you will coordinate and manage the full lifecycle of Regulatory Submissions translation and localization projects for Marketing Authorization, ensuring IQVIA's quality standards and timely delivery. · ...

  • Associate Tax

    hace 4 semanas

    Quito PwC Full time

    Ejecutar tareas asignadas para la elaboración de impuesto a la renta de personas naturales y sociedades; · Ejemplo: responsabilidades · Ejemplificar tarea 1 · ejemplicar tarea 2 · ...

  • Associate Tax

    hace 3 semanas

    Quito PwC

    Responsable de la ejecución y entrega de tareas asignadas dentro un proyecto al Senior Associate. Ejecutar tareas asignadas para la elaboración de impuesto a la renta de personas naturales y sociedades; conciliación tributaria, declaraciones y anexos ante la administración tribut ...

  • Local Pharmacovigilance Officer

    hace 3 semanas

    Quito Sitero LLC Freelance

    The Local PV Officer works collaboratively with Global PV staff and cross-functional colleagues/teams for pharmacovigilance activities and ensuring regulatory compliance according to the applicable regional and national laws. · ...

  • Pasante Outsourcing

    hace 4 semanas

    Quito PwC Full time

    Realizar tareas asignadas por el área para dar soporte en lo requerido. · Estudiantes de carrera de contabilidad o carreras afines. · Inglés intermedio. · ...

  • Manager Tax

    hace 4 semanas

    Quito PwC Full time

    Responsable de garantizar la ejecución calidad administración de los proyectos tax cumplir metas establecidas en BSC cuidar relacionamiento entre cliente PwC. · ...

  • Senior Security Specialist

    hace 23 horas

    Quito ELEKS

    ELEKS is looking for a Senior Security Specialist (Cybersecurity) to work on-site in Quito, Ecuador. · ...

  • Senior Security Specialist (Cybersecurity), #43244

    hace 3 semanas

    Quito Eleks Full time

    ELEKS is looking for a Senior Security Specialist (Cybersecurity) to work on-site in Quito, Ecuador. · ...

  • Senior Security Specialist

    hace 3 semanas

    Quito ELEKS

    We are looking for a Senior Security Specialist (Cybersecurity) to design and enforce secure-by-design architecture for enterprise-scale systems within a Microsoft ecosystem. · Design and enforce secure-by-design architecture for enterprise-scale systems within a Microsoft ecosys ...

  • UNOPS Registration Assistant

    hace 2 meses

    Quito UNHCR, the UN Refugee Agency Full time

    The Registration Assistant is a member of the registration team and is supervised by a more senior colleague who normally reports directly to the Registration Officer. The incumbent is responsible for supporting all activities related to registration which may also include functi ...

  • Associate Tax

    hace 4 semanas

    Quito, Pichincha PwC $100.000 - $150.000 per year

    Responsable de la ejecución y entrega de tareas asignadas dentro un proyecto al Senior Associate. · A 2 años de experiencia en temas tributariosGraduados en Administración de Empresas, Ingeniería Comercial, Economía, Ingeniería en Contabilidad y Auditoría, Ingeniería en Finanzas ...

  • Construction Engineering Specialist

    hace 1 mes

    Quito ATSG Corporation

    The U.S. Department of State is seeking a Construction Engineering Specialist to support its mission in Quito, Ecuador. · ...

  • Principal, Services Business Development

    hace 2 semanas

    Quito Mastercard Full time

    Mastercard Services is responsible for acquiring engaging and retaining customers by managing fraud risk cybersecurity and improving the digital payments experience. · Lead sales calls and new client development across all lines of Services Business for an assigned set of account ...

  • Software Architect, #43241

    hace 1 semana

    Quito Eleks Full time

    The project focuses on building and evolving a large-scale public financial platform in Latin America, with high requirements for security, scalability, and reliability. · We are looking for a Software Architect to work on-site in Quito, Ecuador.,5-7+ years senior-level experienc ...

  • Operations Assistant

    hace 1 mes

    Quito Latino Legends Full time$1.400 - $1.800

    We are seeking a highly organized and detail-oriented Operations Assistant to support two U.S.-based professional services firms. The ideal candidate will be proactive, reliable, and comfortable working independently while managing administrative responsibilities across multiple ...

  • Principal, Services Business Development

    hace 3 semanas

    Quito Mastercard

    We support a wide range of digital payments choices making transactions secure simple smart and accessible. We are responsible for acquiring engaging and retaining customers by managing fraud and risk cybersecurity improving the digital payments experience while providing value a ...

  • Senior R Shiny Developer

    hace 1 semana

    Quito Scale Up Recruiting Partners $80.000 - $120.000 per year

    +Job summary · About The Company · Our client is looking to hire a Senior R Shiny Developer to join their international, fully remote team. · You'll be part of a collaborative, · multidisciplinary environment where data, · design and technology come together to build high-impact ...

  • Principal, Services Business Development

    hace 3 semanas

    Quito Mastercard Full time

    Lead sales calls and new client development across all lines of Services Business for an assigned set of accounts. · Deliver against sales targets for existing accounts and/or contribute to Mastercard Worldwide deal bids. · Capture senior and mid-level clients' implicit business ...

  • AI Director

    hace 2 semanas

    Quito Kushki

    Kushki is seeking a talented AI Director to lead the company's AI-First transformation. The ideal candidate will have experience with hands-on AI projects and partnerships with leading AI companies. · Lead the identification, evaluation, and adoption of world-class artificial int ...

  • Software Architect

    hace 1 semana

    Quito ELEKS

    ELEKS is looking for a Software Architect to work on-site in Quito, Ecuador. · ...

  • Operations Assistant

    hace 3 semanas

    Quito Latino Legends Full time$1.400 - $1.800

    We are in search of a highly organized and detail-oriented Operations Assistant to support two U.S.-based professional services firms. The ideal candidate is proactive, reliable, and comfortable working independently while managing administrative responsibilities across multiple ...