Senior Translations Project Manager – Regulatory submissions Pharma

hace 1 semana

Mar del Plata, Buenos Aires, Argentina IQVIA A tiempo completo

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

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