Associate Medical Writer (Home Based - South Africa)

This position is a home-based role out of any location in South Africa.

• Has basic understanding of regulations and guidance as they pertain to medical writing.
• Trained on styles of writing for various document types.
• Has understanding of QC process.
• Trained on general instructions on process, detailed instructions on MW deliverables and client/MMS processes.
• Trained on templates, toolbars and formatting.
• Understands MMS and client processes and training; is 100% compliant.
• Has basic understanding of impact of updates in related deliverables.
• Trained on managing client meetings and CRMs.
• Trained and has basic understanding of managing a project from start to finish.
• Has basic understanding of identifying and mitigating project risk, including assessing client gaps.
• Has basic understanding of handling client feedback
• Can set up QC trackers. Can lead projects with guidance.
• Can incorporate straightforward comments. Can format documents.

• College graduate in scientific, medical, clinical discipline or related field, or related experience, masters or PhD preferred.
• 0-2 years of experience in Medical Writing or similar field preferred/required.
• Knowledge of scientific principles and concepts.
• Proficiency with MS Office applications.
• Hands on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.