Clinical Research Assistant Specialist

In this role, you will be responsible for the preparation of related eCTD modules, following bioequivalence and clinical trial processes and participating in monitoring activities. You will report to the Clinical Research & Pharmacovigilance Manager.

• Conducting the necessary literature research and completing preliminary preparations for products requiring Clinical and/or Bioequivalence studies,
• Communicating verbally and in writing with Contract Research Organizations (CROs) regarding domestic and international processes,
• Following up on all processes related to the initiation, conduct, and reporting of Clinical and/or Bioequivalence studies after signing agreements with CROs, ensuring the provision of required documentation, and maintaining relevant records,
• Following national and international regulations and guidelines related to Clinical and Bioequivalence studies,
• Preparing expert reports in both Turkish and English (Module 2.4, Module 2.5, Module 2.7.1, Module 4, and Module
  5),
• Conducting and reporting monitoring visits,
• Participating in all activities required by the department and maintaining relevant records.

• Graduated from Pharmacy, Molecular Biology/Genetics or similar departments of universities (master degree is prefered),
• Having at least 1 year of experience in Clinical Research and Bioequivalence studies,
• Good knowledge of MS Office applications,
• No restrictions on domestic and international travel,
• Proficient in written and spoken English.

Nobel’s proven excellence in the global pharmaceutical sector is driven by the dedication and expertise of our people. Since 1954, we have grown from our roots in Türkiye into a global pharmaceutical company, thanks to the dedication and expertise of nearly 5,000 colleagues.

We operate 6 R&D and production hubs across Türkiye, Kazakhstan, and Uzbekistan, and our presence spans 24 countries with dedicated local teams. Our multicultural and multinational colleagues embody our global presence, ensuring that our products reach patients in more than 50 countries.

What unites us is our mission:
Health for All, Access for All. Every day, we work with passion to improve the quality of human life because at Nobel, every contribution makes a difference.