Senior Medical Writer (Home Based - South Africa) …, Johannesburg

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Senior Medical Writer We are recruiting for a Medical Writer to join our South African team. This position is a home‑based role out of any location in South Africa.

Roles&Responsibilities

Under minimal supervision, the Medical Writer will 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

Highly proficient with styles of writing for various regulatory documents

Expert proficiency with client templates&style guides

Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects

Contribute substantially to, or manages, production of interpretive guides

Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary

Mentor medical writers and other members of the project team who are involved in the writing process

Requirements

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

Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus

Understanding of clinical data

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

Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus

Substantial clinical study protocol experience, as lead author, required

Experience leading and managing teams while authoring regulatory documents with aggressive timelines

Not required, but experience with orphan drug designations and PSP/PIPs a plus

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

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