Associate Director, Translations Regulatory Submissions Project Management

hace 2 semanas


Madrid, Madrid, España IQVIA A tiempo completo

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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