Madrid, Spain
18 hours ago
Senior Translation Project Manager - Regulatory Submissions

SENIOR TRANSLATION PROJECT MANAGER – REGULATORY SUBMISSIONS

Working with the wider Project Management team, the Senior Translation Project Manager – Regulatory Submissions is responsible for coordinating and managing the full lifecycle of Regulatory Submissions for Marketing Authorization translation and localization projects to completion whilst ensuring IQVIA’s standards are met. 
 

Manage multiple Regulatory Submissions translation and localization projects at any one time from receipt to completion

Liaise with the client to assess and agree project parameters and requirements

Act as main point of contact for internal/external clients and manage their requirements plus any escalations or issues that may arise

Manage client accounts, assigning projects internally within the PM team whilst ensuring client needs are met

Assess project scope to select appropriate vendors and negotiate deadlines effectively

Establish and maintain excellent relationships with freelance and in house linguists globally

Monitor and manage the status of assigned projects to effectively anticipate and prevent issues

Accurately complete project finances including quoting and budgeting

Prepare and maintain project documentation and information

Understand and adhere to the Quality Management System 

Comply with relevant and applicable IQVIA procedures and SOPs

Work with Team Leads to help in the training and development of junior staff

Assist in the maintenance of linguistic assets including glossaries and style guides

Ensure that high quality is maintained for all projects through QA checks

Provide weekend coverage in case needed due to project schedule

Provide and follow up on quotations

Requirements: 
 

Minimum of 4 years of experience working in Project Management in the Language Services industry

Specialist in Regulatory Submissions Marketing Authorization Project Management within the Language Services industry. Experience working in Submissions for FDA, APAC, Latam, MENA and/or Canada would be highly advantageous

Experience developing, managing and being the key point of contact on client accounts

Advanced client management skills with the ability to nurture new client relationships

Bachelor's degree, ideally in a linguistic, business or scientific field

Fluency in English is essential, an additional language would be advantageous

Excellent written/verbal communication skills

Excellent attention to detail to ensure that high quality standards are maintained

Ability to meet strict deadlines and to manage competing priorities and changing demands

Excellent client management, problem solving and analytical skills

Ability to follow instructions and work independently whilst using own initiative

Demonstration of advanced IT skills

Experience working with TMS and CAT tools, experience working with XTRF and/or memoQ would be highly advantageous

Ability to establish and maintain effective working relationships with colleagues, managers and clients

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 at https://jobs.iqvia.com.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.

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