Start-up Specialist France

il y a 23 heures

RueilMalmaison, France Labcorp Temps plein

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?**

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.

Your main responsibilities will comprise:
**Regulatory Authorities and Ethic Committee Submissions**:

- Initial
- Amendment
- Preparation of the country Clinical Trial Application Submission Form (FAEC)
- QC of CTA package dispatch including IMPD & label
- Synopsis review
- 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
- Submission on SIRIPH (French EC website)
- Follow up on questions and answers, approval

Does this sound appealing to you?

**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.

For more information about how we collect and store your personal data, please see our Privacy Statement.

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