Senior Translation Project Manager Regulatory Submissions

Madrid - Spain

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

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 IQVIAs 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
Bachelors 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 .

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.

Required Experience:

Senior IC

SENIOR TRANSLATION PROJECT MANAGER REGULATORY SUBMISSIONSWorking 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 an...

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
Bachelors 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

Required Experience:

Senior IC

Key Skills

Proofreading
Adobe Acrobat
FDA Regulations
Manufacturing & Controls
Biotechnology
Clinical Trials
Research & Development
GLP
cGMP
Product Development
Chemistry
Writing Skills

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About Company

IQVIA

IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more

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