Associate Director, Translations Regulatory Submissions Project Management
hace 3 meses
The Associate Director Regulatory Submissions is responsible to lead 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.
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.
Collaborate with Vendor Managers to develop an extensive network of Regulatory Submissions linguists and subject matter experts
Monitor and manage the status of the teams' projects to effectively anticipate and prevent issues
Ensure that the team accurately and timely complete project finances including quoting and budgeting
Understand and adhere to the Quality Management System
Comply with relevant and applicable IQVIA procedures and SOPs
Maintain and update SOPs when applicable
Work with Team Leads to help in the training and development of junior staff
Closely collaborates to Quality and Compliance team to ensure best standards are reach.
Ensure that high quality is maintained for all projects through QA checks and comprehensive CAPA plans
Contribute to develop a continues improvement culture where productivity and quality standards ) should be raised year by year through the usage of state of the art technologies and IQVIA Lean Best Practices
Get trained as IQVIA Lean Manager to be able to effectively lead / Collaborate in IQVIA Lean initiatives
When assigned, ensures the team is closely aligned to collaborate and meet priorities defined by project PIC (Principal in Charge)
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
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. Learn more at
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Madrid, España Iqvia A tiempo completo.Associate Director – Regulatory SubmissionsThe 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...
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Madrid, España Iqvia A tiempo completo.```htmlAssociate Director – Regulatory SubmissionsThe 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...
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Madrid, España Iqvia A tiempo completo.Associate Director – Regulatory Submissions 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...
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Madrid, España Https:Www.Energyjobline.ComSitemap.Xml A tiempo completo.The Associate Director – Regulatory Submissions is responsible to lead 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...
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Madrid, España Iqvia A tiempo completo.The Associate Director Regulatory Submissions is responsible to lead 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...
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Madrid, España Iqvia A tiempo completoAssociate Director – Regulatory SubmissionsThe 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...
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Madrid, España Iqvia A tiempo completoAssociate Director – Regulatory SubmissionsThe 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...
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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, España Iqvia A tiempo completoAssociate Director – Regulatory Submissions 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...
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Madrid, España Iqvia A tiempo completoAssociate Director – Regulatory Submissions 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...
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Madrid, Madrid, España IQVIA A tiempo completoRegulatory Submissions Team Lead OpportunityThe 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...
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Madrid, España Sdi Digital Group A tiempo completoThe Associate Director Regulatory Submissions is responsible to lead 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...
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Madrid, España Https:Www.Energyjobline.ComSitemap.Xml A tiempo completoThe Associate Director – Regulatory Submissions is responsible to lead 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...
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Madrid, España IQVIA A tiempo completoThe Associate Director – Regulatory Submissions is responsible to lead 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...
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Madrid, Madrid, España Https:Www.Energyjobline.ComSitemap A tiempo completoJob SummaryThe Associate Director – Regulatory Submissions is a key leadership role within IQVIA Translations, responsible for leading a worldwide Regulatory Submissions delivery team. This team is in charge of developing and harmonizing the Regulatory Submissions Process, working with QRDs, CTDs, SmPC, PIL, and other regulatory materials for EMA,...
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