Associate Director, Translations Project Management
2 weeks ago
The Associate Director – Regulatory Submissions
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 the rest of the world.
Lead Regulatory submission Team Leaders under his/her remit and ensure the whole team meets and exceeds their monthly and yearly goals and objectives.
# Lead and implement processes to improve efficiency and ensure high-quality deliverables for all Regulatory Submissions projects.
# Represent IQVIA Translations in strategic RFP processes as needed for Regulatory Submissions projects.
# Liaise with the client to establish methodologies and to assess and agree project parameters and requirements.
# Collaborate with Vendor Managers to develop an extensive network of Regulatory Submissions linguists and subject matter experts.
# Monitor and manage the status of the team's 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.
# Work with Team Leads to help in the training and development of junior staff.
# Closely collaborate with the Quality and Compliance team to ensure the best standards are reached.
# Ensure that high quality is maintained for all projects through QA checks and comprehensive CAPA plans.
# Contribute to developing a continuous 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.
# When assigned, ensure the team is closely aligned to collaborate and meet priorities defined by project PIC (Principal in Charge).
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 attention to detail to ensure that high-quality standards are maintained.
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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Reading, Berkshire, United Kingdom Iqvia Full timeThe Associate Director – Regulatory Submissions 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...
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Reading, Berkshire, United Kingdom IQVIA Argentina Full timeThe 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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Reading, Berkshire, United Kingdom IQVIA Argentina Full timeThe 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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Reading, Berkshire, United Kingdom Iqvia Full timeThe Associate Director – Regulatory Submissions 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...
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Reading, Berkshire, United Kingdom Iqvia Full timeThe Associate Director – Regulatory Submissions 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...
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Reading, Berkshire, United Kingdom IQVIA Argentina Full timeThe 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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Reading, Berkshire, United Kingdom IQVIA Argentina Full timeThe 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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Reading, United Kingdom IQVIA Full timeThe 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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