(Sr) ICF Writer - South Africa (Remote) SOUTH AFRICA, Johannesburg

About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.

Our mission is to deliver high-quality service and technology solutions– rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life‑changing therapies to positively improve lives worldwide.

MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit or follow MMS on LinkedIn.

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, Informed Consent Forms and Clinical Protocols

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 communication skills for projects

Contribute substantially to, or manage, 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 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

Oncology, General Medicines, Infectious Diseases and Vaccine experience preferred

Substantial informed consent and clinical study protocol experience, as lead author, required

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

Experienced in understanding complex clinical information

Translate complex medical and scientific information into clear, patient‑friendly language

Experienced in collaboration and cross‑functional communication

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

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

Should you not have received a response within 14 days of your application, please consider your application unsuccessful.

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