
Submissions Coordinator
5 days ago
Unlock Your Career Potential with Parexel International
We are looking for a talented Senior Regulatory & Submissions Specialist to join our team in Istanbul or Ankara.
This is an excellent opportunity to develop your skills and expertise in regulatory compliance, submissions, and project management.
About the Role:
- Contribute to the success of our studies by ensuring performance and compliance with assigned protocols in a country.
- Collaborate with cross-functional teams to ensure successful study execution.
Requirements:
- Mandatory - experience in EC and RA submission, 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.
- Skilled 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, standard of care, etc.).
- Experience in validation of translated documents.
You will enjoy a competitive compensation package, opportunities for career growth and development, and a supportive work environment.
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