Associate Director, Translations Regulatory Submissions Project Management
hace 2 semanas
Regulatory Submissions Team Lead Opportunity
The Associate Director – Regulatory Submissions is responsible for leading a worldwide Regulatory Submissions delivery team within IQVIA Translations.
This team is in charge of the development and harmonization of the Regulatory Submissions Process.
The Associate Director – Regulatory Submissions has experience working with QRDs, CTDs, SmPC, PIL and any other regulatory materials for EMA, SwissMedic, FDA and rest of the world.
Key Responsibilities:
• Lead Regulatory submission Team Leaders under his/her remit and ensure the whole team meets and exceed their monthly and yearly goals and objectives
• Lead and implement processes to improve efficiency and to ensure high quality deliverables for all Regulatory Submissions projects
• Coordinate with colleagues in other departments to develop and expand on existing workflows and offerings
• Represent IQVIA Translations in strategic RFP processes as needed for Regulatory Submissions projects
• Act as main point of contact for internal/external clients and manage any escalations or issues that may arise within the team
• Liaise with the client to establish methodologies and to assess and agree project parameters and requirements
• Prepare and implement smooth on-boarding plans for future new clients
• Coordinate and communicate with interviewers and recruiters for the purpose of conducting debriefing interviews, analysing results, and making recommendations for improvements.
Requirements:
• Minimum of 5 years of experience specializing in Regulatory Submissions as a Manager, Team Leader, Director or Associated Director in the Life sciences Language Services industry
• Experience in leading a team of Project Managers within Regulatory Submissions
• Bachelor's degree, ideally in a linguistic, business or scientific field
• Fluency in English is essential, an additional language would be advantageous
• Experience in Russian Regulatory submissions will be highly considered
• 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 technical files, 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
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Madrid, Madrid, España Iqvia A tiempo completoJob SummaryThe Associate Director, Translations Regulatory Submissions Project Management will lead a worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is responsible for the development and harmonization of the Regulatory Submissions Process.Key ResponsibilitiesLead Regulatory submission Team Leaders under his/her remit and...
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Madrid, Madrid, España IQVIA A tiempo completoJob Title: Associate Director, Translations Regulatory Submissions Project ManagementAbout the Role:The Associate Director – Regulatory Submissions is a key leadership position within IQVIA Translations, responsible for leading a worldwide Regulatory Submissions delivery team. This team is in charge of developing and harmonizing the Regulatory Submissions...
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