Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Independently provides regulatory support for more complex projects.
Essential Functions
- Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate.
- Competently writes regulatory and/or technical documents with minimal review by senior staff.
- Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues.
- Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate.
- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
- May present to clients at bid defence meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff.
- May write new regulatory SOPs, and/or propose revisions and/or act as reviewer for regulatory SOPs, as assigned and appropriate.
- May be involved in a Regulatory and/or IQVIA Initiative.
- Performs other tasks or assignments, as delegated by Regulatory management.
Qualifications
- Bachelor's Degree Degree in Life science or related discipline Req Or
- Master's Degree Degree in Life science or related discipline Req
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- Demonstrates comprehensive regulatory or technical area of expertise
- Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
- Strong software and computer skills, including MS Office applications
- Demonstrated skills in chairing small meetings
- Ability to work on several projects, retaining quality and timelines and can prioritise workload with minimal supervision
- Ability to propose revisions to SOPs or suggest process improvements for consideration
#LI-CES #LI-DNI
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
