Clinical Research Assistant Specialist

Nobel Ilac A.S; Ümraniye; On-site; TRY 120,000 - 180,000; Full time

Job summary

Nobel Ilac A.S is seeking a Clinical Research professional to prepare eCTD modules and coordinate BE studies. You will liaise with CROs for domestic and international processes and ensure timely documentation and reporting of trials.

You should have a background in Pharmacy or Molecular Biology/Genetics with 1+ year of BE/Clinical Research experience, strong English skills, and travel flexibility to support global regulatory activities.

Qualifications

• Graduated from Pharmacy, Molecular Biology/Genetics or similar departments; master degree preferred.
• 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.

Responsibilities

• Preparing related eCTD modules and supporting Clinical and Bioequivalence trials.
• Communicating with CROs about domestic and international processes.
• Ensuring documentation and records are maintained for initiation, conduct and reporting of studies.
• Adhering to national and international regulations for Clinical and Bioequivalence studies.
• Preparing expert reports in Turkish and English (Modules 2.4, 2.5, 2.7.1, 4 and 5).
• Conducting and reporting monitoring visits.
• Collaborating with the department and maintaining relevant records.

Skills

Clinical Research

Bioequivalence studies

MS Office

English proficient

Education

Pharmacy

Molecular Biology/Genetics

Job description

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.

What You'll Be Doing?

• 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.

Which Profile Are We Looking For?

• 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.