パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Senior Regulatory & Submissions Specialist ( COMR ) FSP
応募 求人ID R0000035841 ロケーション イスタンブール, イスタンブール 仕事内容Parexel FSP is currently hiring Senior Regulatory & Submissions Specialist
positions in Istanbul or Ankara.
Currently, the position is hybrid office-based.
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.
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.
· 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, 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.
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