(Sr) Medical Writer (Home Based - South Africa)
On-siteJohannesburg, Gauteng, South Africa or Cape Town, Western Cape, South Africa
Job Summary
Critically evaluate, analyze, and interpret medical literature to select primary resources for study design, statistical significance, and scientific rigor. Write and edit clinical development documents including protocols, investigator's brochures, clinical study reports, consent forms, safety summaries, and regulatory Module 2.7 documents. Complete writing assignments timely while maintaining workflow and timelines. Interact directly and independently with clients to coordinate project facets and contribute to interpretive guides. Mentor project team members involved in the writing process. This home-based role is based in South Africa for a Senior Medical Writer at MMS, a clinical research organization supporting pharmaceutical, biotech, and medical device industries. Substantial oncology experience and lead authorship of clinical study protocols are required.
Required Qualifications
- At least 3 years of previous experience in the pharmaceutical industry
- Must have at least 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
- Substantial Oncology experience required
- Substantial clinical study protocol experience, as lead author, required
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- Exceptional writing skills are a must
- Excellent organizational skills and the ability to multi-task are essential prerequisites
- Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
- Experience being a project lead, or managing a project team
Desired Qualifications
- Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
- Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
- Not required, but experience with orphan drug designations and PSP/PIPs a plus
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.