Regulatory Submissions Project Manager

hace 1 semana

Madrid Centro, Madrid, España IQVIA A tiempo completo
Job Title: Regulatory Submissions Project Manager

We are seeking a highly skilled Regulatory Submissions Project Manager to join our team at IQVIA.

About the Role:

The successful candidate will be responsible for coordinating and managing the full lifecycle of Regulatory Submissions translation and localization projects to completion, ensuring that IQVIA's standards are met.

Key Responsibilities:
  1. Manage multiple Regulatory Submissions translation and localization projects simultaneously, from receipt to completion.
  2. Liaise with clients to assess and agree project parameters and requirements.
  3. Assess project scope to select appropriate vendors and negotiate deadlines effectively.
  4. Establish and maintain excellent relationships with freelance and in-house linguists globally.
  5. Monitor and manage project status to anticipate and prevent issues.
  6. Accurately complete project finances, including quoting and budgeting.
  7. Prepare and maintain project documentation and information.
  8. Understand and adhere to the Quality Management System.
  9. Comply with relevant and applicable IQVIA procedures and SOPs.
  10. Assist in the maintenance of linguistic assets, including glossaries and style guides.
  11. Ensure high-quality projects through QA checks.
Requirements:
  1. Minimum of 2 years of experience in Project Management in the Language Services industry.
  2. Minimum of 1 year of experience in Regulatory Submissions Project Management in the Language Services industry.
  3. Bachelor's degree, ideally in a linguistic, business, or scientific field.
  4. Fluency in English is essential; an additional language would be advantageous.
  5. Excellent written/verbal communication skills.
  6. Excellent attention to detail to ensure high-quality standards are maintained.
  7. Ability to meet strict deadlines and manage competing priorities and changing demands.
  8. Excellent problem-solving and analytical skills.
  9. Ability to follow instructions and work independently while using own initiative.
  10. Demonstration of advanced IT skills.
  11. Experience working with TMS and CAT tools; experience working with XTRF and/or memoQ would be highly advantageous.
  12. Ability to establish and maintain effective working relationships with colleagues, managers, and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry.

We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world.

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