Do you have experience in Study Start Up activities and are you up for a new challenge in a growing company? Do you live in Belgium, the Netherlands, Germany, France or Spain? No problem, work can be done remotely! Don't hesitate and apply today !
Job Description
The Submission Specialist (SUS) coordinates, supports and plans regulatory (start-up) activities within the Study Start-up department of Clinical Trial Operations. This includes the creation and submission of Clinical Trial Application documents and packages (incl. Patient Information and Consent Form) as well as any other communication towards authoritative bodies during the complete lifecycle of a clinical project.
Responsibilities
- Collect information on country specific application procedures
- Determine the format and content of application packages to be submitted to any kind of authoritative body
- Write master- and country versions of the Patient Information and Consent Forms
- Develop and update trackers listing regulatory information, timelines, status, correspondence, and requirements
- Prepare, process and finalize submission documentation in collaboration with study teams and clients
- Liaise with other departments and external parties (e.g., translation vendors) for required submission documents
- Follow up on Clinical Trial Application / submission procedures (e.g., validation correspondence, deficiency letters, requests) in consultation with study teams and clients
- Assess and review regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory and start-up intelligence
- Assist the project teams and clients in ensuring regulatory compliance during the complete lifecycle of clinical projects
- Provide regulatory advice to study teams and sponsors
- Actively support to staff learning & development within the company
- Provide and coordinate regulatory training for relevant staff
- Draft and contribute as Subject Matter Expert (SME) in the field of regulatory start-up activities to the evaluation/improvement of processes and procedures within the Quality Management System
- Assure professional communication and good relationships with (future) clients and authoritative bodies
- Support the preparation of new proposals and bid defenses by providing input related to regulatory submissions
- Contribute to and take part in client evaluations and visits as required
- Contribute to other areas of business as required
- Organize, support, and attend in (scientific advice) meetings with authoritative bodies, if requested
Requirements
- Life science degree
- Minimum 2 years of experience in start-up phases of clinical trials/submissions to EC and CA.
- Thorough knowledge of ICH-GCP(R2), privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and/or applicable local regulatory requirements
- Strong written and verbal communication skills including good command of English language
- Representative, outgoing and client focused
- Process orientate
- Ability to translate guidelines, rules and regulations in clear and usable recommendations
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence, with attention to detail and accuracy
- Proficiency with various computer applications such as Word, Excel, and PowerPoint required
- Existing right to work in Europe
Benefits
- Full-time position
- Remote working
Vacancy number: 18432
