Offre d'emploi n° 9648390

Description du poste

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

Did you know?

In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.

We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www. fortrea. com

We are currently recruiting for our FSPx department a Start-Up Specialist who will be dedicated to one of our client, a well-known pharmaceutical company located in the region of Paris.

Regulatory Authorities and Ethic Committee Submissions

• Initial
• Amendment
• Preparation of the RA submission file following clinical trial application files dispatch
• Preparation of the country Clinical Trial Application Submission Form (FAEC)
• QC of CTA package dispatch including IMPD & label
• Synopsis review
• Preparation of the RA submission file following clinical trial application files dispatch - as applicable
• Submission via Eudralink
• Follow up on intermediate letters, questions and answers, authorization
• Patient information note and consent form; Patient documents; recruitment tools: Quality check and verification of compliance with local law
• Preparation of the EC submission file following clinical trial application files dispatch - as applicable
• Submission on SIRIPH (French EC website)
• Follow up on questions and answers, approval

Does this sound appealing to you?

You can apply today and one of our recruiter will shortly get in touch with you for a first phone conversation.

We look forward to your application!

• Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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