Senior Medical Writer (Home Based - South Africa)

MMS; Johannesburg; Remote; ZAR 200,000 - 300,000; Full time

Job summary

A well-recognized data-focused clinical research organization is seeking a Senior Medical Writer. The role will involve writing and editing essential clinical documents and overseeing project communication. Ideal candidates have 3-5 years in regulatory and clinical writing, particularly in oncology, and exhibit strong organizational skills. This is an exciting opportunity for medical writing professionals looking to advance in a supportive team environment.

Qualifications

• At least 3 years of pharmaceutical industry experience.
• Substantial oncology experience required.
• Exceptional writing and organizational skills.

Responsibilities

• Write and edit clinical development documents.
• Critically evaluate medical literature and select resources.
• Provide excellent internal and external customer service.

Skills

Clinical Research

Technical Writing

Writing Skills

Education

Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline

Tools

MS Word

Adobe Acrobat

MS PowerPoint

Job description

Are you looking to join a company where your contributions truly matter and where you'll be part of a supportive, innovative team? MMS is an award-winning data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry-leading employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains an industry-leading customer satisfaction rating and fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit and follow MMS on LinkedIn.

Senior Medical Writer

We are recruiting for a Medical Writer to join our South Africa team. We seek a motivated self-starter with medical writing experience who is looking for a new challenge. This is a home-based role open to any location in South Africa.

Roles & Responsibilities

• Critically evaluate, analyze, and interpret medical literature to select primary resource materials, ensuring study design, statistical significance, scientific rigor, and absence of bias.
• Write and edit clinical development documents, including clinical protocols, investigator brochures, clinical study reports, subject consent forms, safety and efficacy summaries, and publication materials.
• Complete writing assignments on time, maintaining workflow and timelines.
• Provide excellent internal and external customer service.
• Proficient in styles of writing for regulatory documents, client templates, and style guides.
• Interact directly with clients to coordinate project facets; demonstrate competent communication skills.
• Contribute to or manage the production of interpretive guides.
• Take ownership of assignments, consulting with team members and departments as needed.
• Mentor junior medical writers and project team members involved in writing.

Requirements

• At least 3 years of pharmaceutical industry experience, with 3-5 years in regulatory and clinical medical writing.
• Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
• Substantial oncology experience required.
• Experience as lead author in clinical study protocols.
• Experience managing teams and authoring regulatory documents under tight deadlines.
• Knowledge of regulatory submissions (clinical study reports) is a plus.
• Understanding of clinical data, federal regulations, GCP, and ICH guidelines is advantageous.
• Exceptional writing and organizational skills, with proficiency in MS Word, Excel, PowerPoint.
• Experience leading projects or managing teams.
• Experience with orphan drug designations, PSPs, or PIPs is a plus.

Please note that if we do not contact you within 14 days of your application, consider your application unsuccessful.

Key Skills

Clinical Research, Adobe Acrobat, FDA Regulations, Technical Writing, Biotechnology, Clinical Development, Clinical Trials, Microsoft PowerPoint, Research Experience, Document Management Systems, Word Processing, Writing Skills

Employment Type : Full-Time

Experience : Years

Vacancy : 1