RA CTA Lead Consultant (remote-based)
- Company
- Hobson Prior
- Ort
- Switzerland
- Gehalt
- £58.30 - £74.96 per hour
- Veröffentlicht
- Freitag, 18. Juni 2021
- Ablaufdatum
- Freitag, 16. Juli 2021
- Ref.
- BBBH16778
- Kontakt
- Hani Moussalli
- Fachbereich
- Arzneimittelzulassung
- Stunden
- Vollzeit
- Vertragstyp
- Befristetes Arbeitsverhältnis
- Erfahrung
- Erfahren (keine Management-Erfahrung)
Hobson Prior are looking for a RA CTA Lead Consultant to join a top Biotechnology organisation who specialise within Rare Diseases. This position will be on a contract basis to be remote and/or on site in Switzerland
Please note that to be considered for this role you must have the right to work in this location.
Key Responsibilities:
- Develop the CTA submission strategy for clinical trials.
- Act as an accountable interface regarding regulatory CTA topics within Regulatory and between Regulatory and other key functions, and providing strategic input.
- Prepare, compile and submit country-specific CTA dossiers in selected countries and act as single point of contact for authority communication / interactions.
- Liaise with other GRA functions as well as with key functions within Clinical Research and Development, Clinical Operations, Global Clinical Safety & Pharmacovigilance, Clinical Trial Supply, pre-Clinical, Legal Affairs and CRO and organize the timely and effective generation of CTA documents to ensure CTA submission is performed on time and with high quality documents.
- Contribute to or review key documents such as, but not limited to CSP, IB, IMPD, IMP labels, DSUR.
- Prepare and approve core CTA dossier.
- Oversee preparation of country-specific CTA dossiers and ensure consistency with core CTA dossier.
- Manage interactions between Competent Authorities (CA) and The company by leading the response to any CA questions in regard to CTA.
- Disseminate the CTA project status like CTA submission, CTA approval, CA questions to the concerned stakeholders.
- Ensure accurate and timely tracking and archiving of CTA activities in the company systems.
Requirements:
- Educated BSc/MSc or equivalent in life science, pharmacy, medical laboratory technology or other health/medical related area preferred.
- As a guide, a minimum of 5+ years' experience in managing Clinical Trial Authorizations.
- Broad knowledge of regulatory requirements in key markets for obtaining Clinical Trial Authorizations.
- Extensive and comprehensive knowledge of ICH guidelines/GCP and current medical/scientific/regulatory knowledge.
- Experience in scientific/medical research.
- Demonstrated sound judgment and flexible approach to managing situations.
- Customer service focus.
Apply now:
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.