Senior Medical Writer (Home Based - South Africa)

Mms Holdings Inc.; KwaZulu-Natal; Remote; ZAR 500 000 - 700 000; Full time

Job summary

A leading CRO is seeking a Senior Medical Writer for their South Africa team. This home-based role requires a motivated individual with medical writing experience. Responsibilities include writing clinical documents, managing assignments, and mentoring team members. Ideal candidates will have substantial oncology experience and a strong understanding of clinical data and regulatory guidelines.

Qualifications

• Minimum 3 years of pharmaceutical industry experience.
• 3-5 years in regulatory and clinical medical writing.

Responsibilities

• Write and edit clinical development documents.
• Manage writing assignments efficiently.
• Mentor other medical writers.

Skills

Writing

Organizational Skills

Multitasking

Education

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

Tools

MS Word

Excel

PowerPoint

Job description

MMS is an innovative, data-focused CRO supporting the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory submissions.

Our strengths include industry experience, technology-enabled services, and a data-driven approach to drug development, making MMS a valuable CRO partner that creates compelling submissions meeting rigorous regulatory standards.

With a global presence across four continents, MMS boasts a 97 percent customer satisfaction rating and has been recognized as a leading CRO in Global Health & Pharma's international awards for three consecutive years.

For more information, visit our website or follow MMS on social media.

Senior Medical Writer

We are recruiting a Medical Writer for our South Africa team. We seek a motivated self-starter, preferably with medical writing experience, eager for a new challenge. This is a home-based role anywhere in South Africa.

Responsibilities

1. Evaluate, analyze, and interpret medical literature to select primary resources for study design, statistical significance, scientific rigor, and bias avoidance.
2. Write and edit clinical development documents such as protocols, investigator's brochures, clinical study reports, consent forms, safety and efficacy summaries, and publications.
3. Manage writing assignments efficiently, maintaining timelines and workflow.
4. Provide excellent customer service internally and externally.
5. Proficiently write regulatory documents following client templates and style guides.
6. Interact with clients independently to coordinate project aspects and communicate effectively.
7. Contribute to or manage the production of interpretive guides.
8. Own assigned tasks, consulting team members as needed.
9. Mentor other medical writers and project team members involved in writing.

Requirements

• Minimum 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 field.
• Substantial oncology experience and clinical study protocol leadership required.
• Experience managing teams and authoring regulatory documents under tight deadlines.
• Regulatory submission experience (clinical study reports) is advantageous.
• Strong understanding of clinical data, federal regulations, GCP, and ICH guidelines is preferred.
• Exceptional writing, organizational, and multitasking skills.
• Expertise in MS Word, Excel, PowerPoint, and project management.
• Experience leading projects or managing teams is desirable.
• Experience with orphan drugs, PSPs, or PIPs is a plus.

Please note, if you do not hear from us within 14 days of application, consider your application unsuccessful.