https://bayt.page.link/CT3ocimSfVGuZgVCA
أنشئ تنبيهًا وظيفيًا للوظائف المشابهة

الوصف الوظيفي

Company Description

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.



Job Description

Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.


Hybrid role in Ankara, Türkiye
 


You will:


  • Prepare independently clinical trial submission dossiers for Regulatory and Ethics Authorities
  • Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
  • Review translations of essential documents subject to clinical trial submission
  • Track the regulatory project documentation flow
  • Review documents to greenlight IP release to sites
  • Manage safety reporting to authorities.
  • Deliver regulatory training to project teams.
  • Assist with feasibility research and business development requests.

Qualifications
  • College/University degree
  • Minimum 1 year of prior industry experience
  • Full working proficiency in English and Turkish
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills


لقد تجاوزت الحد الأقصى لعدد التنبيهات الوظيفية المسموح بإضافتها والذي يبلغ 15. يرجى حذف إحدى التنبيهات الوظيفية الحالية لإضافة تنبيه جديد
تم إنشاء تنبيه للوظائف المماثلة بنجاح. يمكنك إدارة التنبيهات عبر الذهاب إلى الإعدادات.
تم إلغاء تفعيل تنبيه الوظائف المماثلة بنجاح. يمكنك إدارة التنبيهات عبر الذهاب إلى الإعدادات.