Clinical Research & Bioequivalence 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

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.