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.