Entreprise:
Description de l'annonce:
We are looking for a CTA Submission Officer to join our team, and you will have the opportunity to assist the team with:
Responsibilitie
- Assist in drafting and updating key documents
- Perform updates when new regulation or new practical information becomes available.
- Consult the systems for the clinical study pre-requisites in each country.
- Prepare core documentation for Clinical Trial Application (CTA).
- Liaise with concerned authorities about administrative questions, in order be within expected timelines.
- Amendment File preparation
- In charge of updating the information registered in main public registries, in accordance with instructions provided in the corresponding quality document (linked to clinical trials).
- Involved in redaction of regulatory sections .
- Notification to the ANSM of New Event/Urgent Safety Measure
- Retrieves the anonymized CT synopsis and the lay summary, and is in charge of initiating the publication of results documents in the website back office, including their upload.
- Enters the date of publication of documents linked to clinical trials in the dedicated tracking table.
- Manage achievement steps for submission of CT report synopsis to countries.
- Participate in the preparation of any inspection relating to a CT
- In charge of training the employees to European CT Regulation
Education
- Bachelor’s degree in life Science/ Pharmacy related field
Experience
- Min 1 year of experience in Regulatory Affairs/ Pharmacist
- CTA Worldwide knowledge (Japan, China, India, Canada)
- Monitoring clinical research
- Protocol creation
Skills
- Fluent in English/ French (written &spoken)
- Excellent attention to detail
- Ability to work well within a team
- Good time management skills
- Ability to work to tight deadlines
- Process oriented
- Excellent communication skills
