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Associate Clinical Trial Regulatory Services - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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Associate 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.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.Scope of responsibilities:- To prepare and coordinate of regulatory deliverables for assigned projects including close cooperation with regulatory authorities.- To act as local regulatory contact and regulatory lead for assigned studies- Preparing, reviewing and compiling regulatory CTA applications, amendments, and end of trial notifications.- Working under the general direction of the CTRS Manager/Project Manager, taking responsibility for ensuring that the client work is performed and delivered on time.- 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 and national requirements.- May prepare and/ or deliver presentation with the support of senior colleagues.- Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope.Requirements:- Fluency in English is a must.- A degree in Life Sciences. Advanced degree will be an asset.- Regulatory experience with Clinical Trials.- Previous experience in Regulatory Affairs and Clinical Research.- Experience in clinical study start-up.- She/he has worked already in an international environment or CRO.- Ability to work with a multinational team, focusing on multiple issues under tight timelines.- Good Computer skills.


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