Regulatory Submissions Project Manager
hace 2 semanas
Regulatory Submissions Project Manager
At IQVIA, we are seeking a highly skilled Regulatory Submissions Project Manager to join our team. As a key member of our Project Management team, you will be responsible for coordinating and managing the full lifecycle of Regulatory Submissions translation and localization projects to completion.
Key Responsibilities:
- Manage multiple Regulatory Submissions translation and localization projects at any one time from receipt to completion
- Liaise with clients to assess and agree project parameters and requirements
- 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
- Assist in the maintenance of linguistic assets including glossaries and style guides
- Ensure that high quality is maintained for all projects through QA checks
Requirements:
- Minimum of 2 years of experience working in Project Management in the Language Services industry
- Minimum of 1 year of experience working in Regulatory Submissions Project Management in the Language Services industry
- 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 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 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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