Associate Director, Translations Regulatory Submissions Project Management

hace 3 semanas


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 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



  • Madrid, España Iqvia A tiempo completo

    .The Associate Director – Regulatory SubmissionsThe 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...


  • Madrid, Madrid, España Iqvia A tiempo completo

    The Associate Director – Regulatory SubmissionsThe 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...


  • Madrid, Madrid, España Iqvia A tiempo completo

    The Associate Director – Regulatory SubmissionsThe 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...


  • Madrid, España Sdi Digital Group 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...


  • Madrid, Madrid, España IQVIA A tiempo completo

    TRANSLATION QC JUNIOR PROJECT MANAGER – REGULATORY SUBMISSIONSWorking with the Regulatory Submissions Project Management team, the Translation QC Project Manager – Regulatory Submissions is responsible for coordinating and performing the QC step for the Regulatory Submissions translation and localization projects whilst ensuring IQVIA's standards are...


  • Madrid, Madrid, España IQVIA A tiempo completo

    TRANSLATION QC JUNIOR PROJECT MANAGER – REGULATORY SUBMISSIONSWorking with the Regulatory Submissions Project Management team, the Translation QC Project Manager – Regulatory Submissions is responsible for coordinating and performing the QC step for the Regulatory Submissions translation and localization projects whilst ensuring IQVIA's standards are...


  • Madrid, España Radisson Hotel Group, Madrid Office- Revenue Management A tiempo completo

    Radisson Hotel Group is one of the world's largest hotel groups with nine distinctive hotel brands, and more than 1,600 hotels in operation and under development in 120 countries. The Group’s overarching brand promise is Every Moment Matters with a signature Yes I Can! service ethos. People are at the core of our business success and future. Our people...


  • Madrid, España Iqvia A tiempo completo

    .Prepares and / or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programsRESPONSIBILITIESActs as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customerAbility to administratively...


  • Madrid, España Medpace, Inc. A tiempo completo

    Job Summary: Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Graduate to join our Clinical Operations team as a Entry Level Regulatory Submissions Coordinator. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your...


  • Madrid, España TFS HealthScience A tiempo completo

    Overview: TFS HealthScience is excited to be expanding our **Ophthalmology Project Management **team and we are looking for an experienced, highly motivated **Director** **Project Management (DPM) **who shares our vision of providing clinical research excellence. Our **Ophthalmology Project Management **team is a highly experienced international group of...


  • Madrid, España Jr Spain A tiempo completo

    col-wideJob Description:We are looking for Regulatory Affairs Project Manager to join an innovative pharma company to lead the regulatory strategy of drug development.Reporting directly to the Regulatory Affairs Associate Director, you will be responsible:Managing the Regulatory aspects related to the development, registration and licence maintenance of one...


  • Madrid, España Radisson Hotel Group, Madrid Office- Revenue Management A tiempo completo

    Radisson Hotel Group is one of the world's largest hotel groups with nine distinctive hotel brands, and more than 1,600 hotels in operation and under development in 120 countries. The Group’s overarching brand promise is Every Moment Matters with a signature Yes I Can! service ethos. People are at the core of our business success and future. Our people...


  • Madrid, España Radisson Hotel Group, Madrid Office- Revenue Management A tiempo completo

    Radisson Hotel Group is one of the world's largest hotel groups with nine distinctive hotel brands, and more than 1,600 hotels in operation and under development in 120 countries. The Group’s overarching brand promise is Every Moment Matters with a signature Yes I Can! service ethos. People are at the core of our business success and future. Our people...


  • Madrid, España Labcorp A tiempo completo

    The Associate Project Manager Start Up is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client. The position has a significant impact on how a country can deliver country-specific trial...


  • Madrid, España NonStop Consulting A tiempo completo

    Our client is an expanding mid-sized CRO who's looking for several Regulatory Submissions Coordinators for their office in Madrid. If you're a junior clinical research professional that wants an opportunity to work on one of the top companies in the world this is your chance. The role is office based in Madrid with the possibility to work 8 days per month...


  • Madrid, España AstraZeneca A tiempo completo

    **Associate Director, Global Project Management** **Gaithersburg US, Barcelona, Gothenburg Sweden** Competitive salary and benefits At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our...

  • Associate Director

    hace 1 mes


    Madrid, España WTW A tiempo completo

    As an Associate Director, you will work beside some of the industry’s top consultants and for the world’s leading organizations, while you develop cutting edge technical knowledge and skills, as well as project and client management capabilities To be Added by Recruiter


  • Madrid, España IE University A tiempo completo

    Overview: **Associate Director** **Master in Management, IE Business School** Are you ready to join a dynamic team of professionals who are revolutionizing the way we learn? IE University Business School is looking for an **Associate Director** to join its team! The main responsibility of the Associate Director is to supervise the day-to-day management of...


  • Madrid, España Precision Medicine Group A tiempo completo

    .Director / Senior Director, Project Management Director / Senior Director, Project Management EmailPrecision for Medicine is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data...

  • Regulatory Associate

    hace 6 días


    Madrid, España Clarity AI A tiempo completo

    Clarity AI is a global tech company founded in 2017 committed to **bringing social impact to markets.** We leverage AI and machine learning technologies to provide investors, governments, companies, and consumers with the right data, methodologies, and tools to make more informed decisions. We are now a team of more than 300 highly passionate individuals...