Remote Senior Medical Writer

Summary

The job involves critically evaluating medical literature, writing and editing clinical development documents, maintaining timelines, practicing good customer service, and contributing to interpretive guides. The ideal candidate should have at least 3 years of experience in the pharmaceutical industry, hold a degree in a scientific or medical field, and have substantial Oncology experience.

Requirements

• At least 3 years of previous experience in the pharmaceutical industry
• Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline

Responsibilities

• Critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service

Preferred Qualifications

• Substantial Oncology experience required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines

Benefits

Home-based role out of any location in South Africa