As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
$ads={1}
We are currently looking for an experienced Start Up Specialist to join our team in Czech Republic.
Start Up Specialist is responsible for maintaining awareness of regulatory legislation, guidance and practice, ICH/GCP and relevant Sponsor requirements
- Takes ownership in the preparation (collection, organization and compilation) of routine submissions filed to IRB/EC/Third body/Regulatory Authorities (e.g. INDs/CTAs) including but not limited to the preparation of study documentation such as review/summarize scientific/research documents, country application form and cover letter for sponsor review as applicable
- Completes submissions to and liaise with IRB/IEC/Third body/Regulatory Authority as applicable regarding submission/approval issues
- Liaises with internal and external vendors in the generation of Regulatory Authority submissions (as applicable)
- Performs a review of final submission documents as applicable
- Ensures appropriate systems are updated accurately and compliantly, ensuring others follow established processes
- Anticipates and prevents issues and service failures from developing in their study, escalating when appropriate, negotiating when required
- Mentors and coaches other Site Readiness and Regulatory Operations team members
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit
www.fortrea.com
.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea 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.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea 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
.
$ads={2}
