Regulatory Submissions Manager - FSP ( Single Sponsor)
Istanbul, Türkiye ID de la oferta R0000029602 Categoría Clinical Trialssobre este trabajo
Parexel FSP is hiring for a Regulatory & Submissions Manager.
position in Istanbul. The position is hybrid office-based ( office 1 x per month).
Accountable for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
Are you ready to make a real impact on the success of our clinical trials? We’re seeking a talented individual to play a crucial role in ensuring performance and compliance with assigned protocols.
Dedicated to one sponsor, a global pharmaceutical company that leads the way in discovering and developing innovative health solutions that help prevent and treat diseases in animals and people.
Our sponsor has a long history of excellence in research and has delivered medicines, vaccines, and other health solutions for some of the world's most difficult diseases.
Experience required to be a fit for this role:
· Mandatory - experience in EC and RA submission (ideally, familiar with XML completion) – including initial submission and protocol amendments submission.
· Experience in Independently preparing submissions (CTC supports with
document collection) to both EC and RA.
· Experience in ICF preparation using templates.
· Knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.
· Experience in IMP supplies management at the local level (vendors providing background meds, the standard of care, etc.)
· Experience in validation of translated documents.
We offer exceptional financial rewards, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.
#LI-TA1
TRABAJOS PARA TI
There is no jobs to view
En la actualidad no tiene trabajos guardados para ver.
Asegúrese de aceptar las cookies “Funcional” para habilitar este módulo de modo que muestre los enlaces a los trabajos guardados. Podrá revisarlos aquí cuando vuelva a visitar esta página..
Más que un trabajo
