Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Regulatory Submissions Manager - FSP ( Single Sponsor)
Job ID R0000029602 Istanbul, Istanbul, TurkeyParexel 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.
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