Bioequivalence Data Management & Medical Writing Supervisor

MARC for Medical Services and Scientific Research is an integrative research center that aims to advance science by conducting research in interdisciplinary disease areas. Our goal is to conduct high-priority and ethical basic, preclinical and clinical research, bridging the gap between science and community to improve health and quality of life.

MARC is looking to have an experienced candidate for Bioequivalence Data Management & Medical Writing Supervisor

• Key responsibilities:

• Supervise preparation, review, and finalization of study documents including Protocols, Clinical Study Reports (CSR), Statistical Analysis Plans (SAP), and Statistical Analysis Reports (SAR).
• Review and oversee data management activities to ensure data accuracy, consistency, integrity, and timely database lock.
• Perform and review pharmacokinetic (PK) and statistical calculations related to bioequivalence studies.
• Coordinate with biostatistics, bioanalytical, clinical, and regulatory teams to ensure timely, compliant, and high-quality study deliverables.

Requirements

• Bachelor’s degree in pharmacy.
• Minimum 5 years of experience in medical writing, data management, or biostatistics.
• Strong knowledge of bioequivalence requirements, PK analysis, statistical methods, and regulatory guidelines (ICH-GCP, FDA, EMA).
• Strong attention to detail, leadership skills, and ability to review technical and statistical documents accurately