Regulatory Submissions Project Management Director
hace 1 mes
Job Title: Associate Director, Translations Regulatory Submissions Project Management
Job Summary:
The 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 remit and ensure the whole team meets and exceeds 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 on 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 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 when applicable.
- 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 reached.
- Ensure that high quality is maintained for all projects through QA checks and comprehensive CAPA plans.
- Contribute to develop 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.
- Get trained as IQVIA Lean Manager to effectively lead/collaborate in IQVIA Lean initiatives.
- When assigned, ensure 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 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.
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