Associate Director, Regulatory Submissions Project Management Lead
hace 2 semanas
The Associate Director, Regulatory Submissions Project Management Lead is a key member of the IQVIA Translations team, responsible for leading a worldwide Regulatory Submissions delivery team.
Key Responsibilities- Lead a team of Regulatory Submissions Team Leaders to ensure the team meets and exceeds monthly and yearly goals and objectives.
- Develop and implement processes to improve efficiency and ensure high-quality deliverables for all Regulatory Submissions projects.
- Collaborate with colleagues in other departments to develop and expand on existing workflows and offerings.
- Represent IQVIA Translations in strategic RFP processes for Regulatory Submissions projects.
- Act as the main point of contact for internal and external clients, managing escalations and issues within the team.
- Liaise with clients to establish methodologies and assess and agree project parameters and requirements.
- Develop and implement smooth onboarding plans for new clients.
- Coordinate and communicate with interviewers and recruiters for debriefing interviews, analyzing results, and making recommendations for improvements.
- Collaborate with Vendor Managers to develop a network of Regulatory Submissions linguists and subject matter experts.
- Monitor and manage project status to anticipate and prevent issues.
- Ensure the team accurately and timely completes 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 as necessary.
- Work with Team Leads to help in the training and development of junior staff.
- Closely collaborate with the Quality and Compliance team to ensure best standards are met.
- Ensure high-quality is maintained for all projects through QA checks and comprehensive CAPA plans.
- Contribute to developing a culture of continuous improvement, raising productivity and quality standards through the use of state-of-the-art technologies and IQVIA Lean Best Practices.
- Get trained as an IQVIA Lean Manager to effectively lead and collaborate in IQVIA Lean initiatives.
- Align the team to collaborate and meet priorities defined by project PIC (Principal in Charge) when assigned.
- Minimum of 5 years of experience specializing in Regulatory Submissions as a Manager, Team Leader, Director, or Associate 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 and verbal communication skills.
- Excellent attention to detail to ensure high-quality standards are maintained.
- Ability to meet strict deadlines and manage competing priorities and changing demands.
- Excellent problem-solving and analytical skills.
- Ability to follow instructions and work independently while 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 Centro, Madrid, España IQVIA A tiempo completo{"title": "Associate Director Regulatory Submissions", "description": "Job SummaryIQVIA is seeking an experienced Associate Director Regulatory Submissions to lead a worldwide delivery team within our Translations department.Key ResponsibilitiesLead a team of Regulatory Submission Team Leaders to achieve monthly and yearly goals and objectivesDevelop and...
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Madrid, Madrid, España Iqvia A tiempo completoJob SummaryWe are seeking an experienced Associate Director to lead our Regulatory Submissions delivery team within IQVIA Translations. The successful candidate will be responsible for leading a worldwide team of Regulatory Submissions professionals, ensuring the development and harmonization of the Regulatory Submissions Process.Key ResponsibilitiesLead a...
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Madrid, Madrid, España Iqvia A tiempo completoJob SummaryWe are seeking an experienced Associate Director to lead our Regulatory Submissions delivery team within IQVIA Translations. The successful candidate will be responsible for leading a worldwide team of Regulatory Submissions professionals, ensuring the development and harmonization of the Regulatory Submissions Process.Key ResponsibilitiesLead a...
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Madrid, Madrid, España Iqvia 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 responsible for the development and harmonization of the Regulatory Submissions Process.Key Responsibilities:Lead Regulatory submission Team Leaders under your...
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Madrid, Madrid, España Iqvia 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 responsible for the development and harmonization of the Regulatory Submissions Process.Key Responsibilities:Lead Regulatory submission Team Leaders under your...
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Regulatory Submissions Project Manager
hace 2 semanas
Madrid Centro, Madrid, España Iqvia A tiempo completoJob SummaryWe are seeking an experienced Associate Director to lead our Regulatory Submissions team at IQVIA. The successful candidate will have a strong background in regulatory submissions, team leadership, and process improvement.Key Responsibilities:Team Leadership: Lead a team of Regulatory Submission Team Leaders, ensuring they meet and exceed their...
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Regulatory Submissions Project Manager
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Madrid Centro, Madrid, España Iqvia A tiempo completoJob SummaryWe are seeking an experienced Associate Director to lead our Regulatory Submissions team at IQVIA. The successful candidate will have a strong background in regulatory submissions, team leadership, and process improvement.Key Responsibilities:Team Leadership: Lead a team of Regulatory Submission Team Leaders, ensuring they meet and exceed their...
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Madrid, Madrid, España Iqvia A tiempo completoJob SummaryThe Associate Director, Regulatory Submissions Project Management is a key leadership role within IQVIA Translations. This position is responsible for leading a worldwide Regulatory Submissions delivery team, driving the development and harmonization of the Regulatory Submissions Process, and ensuring high-quality deliverables for all Regulatory...
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Madrid, Madrid, España Iqvia A tiempo completoJob SummaryThe Associate Director, Regulatory Submissions Project Management is a key leadership role within IQVIA Translations. This position is responsible for leading a worldwide Regulatory Submissions delivery team, driving the development and harmonization of the Regulatory Submissions Process, and ensuring high-quality deliverables for all Regulatory...
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