Associate Medical Writer (Clinical Research)

TL;DR

Associate Medical Writer (Clinical Research): Developing regulatory documents and clinical trial reports for the pharmaceutical, biotech, and medical device industries with an accent on regulatory compliance and quality control. Focus on drafting technical documents, managing project deliverables, and ensuring adherence to FDA and GCP requirements.

Location: Home-based, must be located in South Africa

Company

hirify.global is an award-winning, data-focused clinical research organization (CRO) supporting pharmaceutical, biotech, and medical device industries globally.

What you will do

• Draft and format various medical writing deliverables and templates.
• Manage the quality control (QC) process and maintain QC trackers.
• Coordinate client meetings and handle client feedback effectively.
• Manage medical writing projects from start to finish with provided guidance.
• Identify and mitigate project risks and assess client gaps.

Requirements

• College graduate in a scientific, medical, or clinical discipline (Masters or PhD preferred).
• 0-2 years of experience in medical writing or a related field.
• Must be based in South Africa.
• Proficiency with MS Office and strong knowledge of scientific principles.
• Familiarity with FDA, GCP, 21 CFR Part 11, and ISO 9001/27001 standards.
• Basic understanding of CRO operations and the drug development process.

Culture & Benefits

• Great Place to Work certified organization with an exceptional culture.
• Industry-leading employee retention rates.
• Collaborative and inclusive work environment.
• Opportunity to work within a global footprint spanning four continents.