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Bioequivalence Data Management & Medical Writing Supervisor at MARC
6th of October, Giza, Egypt -
Full Time

Start Date

Immediate

Expiry Date

23 May, 26

Salary

0.0

Posted On

22 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Data Management, Medical Writing, Bioequivalence, Protocol Review, Clinical Study Reports, Statistical Analysis Plans, Statistical Analysis Reports, Pharmacokinetic Calculations, Statistical Calculations, Data Accuracy, Data Integrity, Database Lock, Biostatistics Coordination, Regulatory Guidelines, ICH-GCP, Leadership

Industry

Research Services

Description
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. 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
Responsibilities
The supervisor will oversee the preparation, review, and finalization of essential study documents such as Protocols, CSRs, SAPs, and SARs. This role also involves reviewing data management activities to ensure data quality and coordinating across various teams for timely study deliverables.