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Administracja biurowa » Pracownik biurowy

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Consultant, Clinical Trial Regulatory Services Nr ref.: /JOBS.pl There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's PAREXEL. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.PAREXEL Consulting is currently looking for a Consultant to join the Clinical Trial Regulatory Services EU Consulting team based in the Prague office.This is an ideal role for someone who would excel working in a fast-paced international team. As part of a multi-national project team, you will take the lead to coordinate the compilation, review and submission of regulatory agency applications for international clinical trials in compliance with international regulatory requirements as well as internal and client standard operating procedures (SOPs). Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies.Key Accountabilities:- To prepare and coordinate of regulatory deliverables for assigned projects including close cooperation with regulatory authorities.- To act as regulatory project leader for assigned international studies. - Preparing, reviewing and compiling regulatory Clinical Trial Approval applications, amendments, and end of trial notifications.- Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, GCP, Regulatory Agency requirements and internal SOPs. - Preparation and review of drug labels to ensure compliance with GMP Annex 13.- Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.Successful candidates should possess:- Minimum of a Bachelor's Degree in Life Sciences or Pharmacy, Advanced Degree strongly preferred.- At least fluent vocal and written English.- 3-5 years of experience in Regulatory Affairs and Clinical Research- Ability to work with a multinational team, focusing on multiple issues under tight timelines.- Project Management experience. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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