FSP Country Approval Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/854hhi

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description
Join us as a Country Approval Specialist and make an impact at the forefront of innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you'll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What you will do:
- Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with EU/global submission strategy
- Provide local regulatory strategy advice (MoH &/or EC) to internal clients




- Provide project specific local start-up services and coordination of these projects
- May have contact with investigators for submission related activities
- Serve as key-contact at country level for either Ethical or Regulatory submission-related activities
- Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation
- Achieve target cycle times for site activation
- Prepare the regulatory compliance review packages, if applicable
- Develop country specific Patient Information Sheet/Informed Consent form documents
- May assist with grant budget(s) and payment schedules negotiations with sites
- May support the feasibility activities, as required, in accordance with agreed timelines
- Enter and maintain trial status information relat

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/854hhi