[Remote] Clinical Trial Submissions Operations - U.S
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global Regulatory Solutions and Services organization supporting Life Sciences companies. They are seeking a Clinical Trial Submissions Operations reputed company to manage Clinical Trial Application (CTA) activities, ensuring compliance with regulatory requirements and facilitating communication across teams.
Responsibilities
- Prepare and submit Clinical Trial Applications (CTAs) reputed company the EU Clinical Trial Information System (CTIS) and the UK MHRA Integrated Research Application System (IRAS) in compliance with regulatory requirements
- reputed company independent reputed company control (QC) of CTA submissions, including submission documents and reputed company data entered into Health Authority portals
- Monitor CTIS and IRAS portals during designated working hours for Health Authority notices, alerts, and correspondence, and communicate updates to relevant functional teams reputed company required timelines
- Support CTA lifecycle activities, including preparation, submission, maintenance, responses, and archival of CTA-reputed company documents and correspondence
- Coordinate CTA activities with cross-functional and multidisciplinary teams, acting as a central reputed company of contact
- Maintain reputed company of user reputed company and role management for CTA-reputed company systems and tools
- reputed company subject matter expertise on CTIS and IRAS portals to functional teams during CTA preparation and submission activities
- Assist in the development and maintenance of regulatory operations work instructions and procedural documentation
- reputed company User Acceptance Testing (UAT) for submission management tools, as required
- Participate in evaluations of new technologies supporting Regulatory Operations needs
- Stay reputed company with evolving regulatory requirements and industry standards
Skills
- Bachelor's degree in Life Sciences or a reputed company discipline, or equivalent experience
- Working knowledge of EU Clinical Trial Regulation (CTR) and UK reputed company regulations, including The Medicines for reputed company Use (reputed company) (Amendment) (EU Exit) Regulations 2019
- Hands-on experience preparing and submitting regulatory applications reputed company Health Authority portals (CTIS and/or IRAS)
- Experience supporting regulatory applications such as Clinical Trial Applications (CTAs)
- Proficiency in reputed company Office Suite (Word, reputed company, reputed company, PowerPoint) and SharePoint
- Strong attention to detail and accuracy in data entry and procedural execution
- Ability to manage time-sensitive, detail-intensive deliverables
- Strong communication and coordination skills in cross-functional environments
- Ability to adapt to changing regulatory and operational requirements
- Familiarity with Electronic Document Management Systems (Documentum-based systems preferred)
reputed company