Senior Medical Writer (Home Based - South Africa)

MMS Holdings Inc.; Bloemfontein; Remote; ZAR 30 000 - 70 000; Full time

Job summary

An innovative data-focused organization seeks a Senior Medical Writer to join its dynamic team in South Africa. This role involves crafting and editing clinical documents, analyzing medical literature, and ensuring compliance with regulatory standards. You will play a crucial part in the development of clinical study protocols and lead writing assignments while mentoring junior writers. If you have a passion for medical writing and a strong background in the pharmaceutical industry, this is an exciting opportunity to contribute to impactful projects. Join a company recognized for its excellence in the CRO sector and make a difference in drug development.

Qualifications

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

Responsibilities

• Write and edit clinical development documents including protocols and reports.
• Critically evaluate and interpret medical literature.
• Mentor junior medical writers and manage writing tasks.

Skills

Medical Writing

Regulatory Submissions

Oncology Experience

Team Management

Communication Skills

Organizational Skills

MS Word

MS Excel

MS PowerPoint

Education

Bachelor's Degree in Scientific or Medical Discipline

Master's Degree

Ph.D.

Tools

MS Word

MS Excel

MS PowerPoint

Job description

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. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit or follow MMS on.

Senior Medical Writer

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

Roles & Responsibilities

1. Critically evaluate, analyze, and interpret medical literature to select primary resource materials ensuring study design, statistical significance, scientific rigor, and absence of bias.
2. Write and edit clinical development documents, including protocols, investigator’s brochures, clinical study reports, subject consent forms, safety and efficacy summaries, and publications.
3. Complete writing assignments within designated timelines.
4. Maintain workflow and adhere to project timelines.
5. Provide excellent internal and external customer service.
6. Proficiently write regulatory documents following styles and templates.
7. Interact directly with clients to coordinate project aspects, demonstrating strong communication skills.
8. Contribute to or manage the production of interpretive guides.
9. Take ownership of assignments, consulting with team members as needed.
10. Mentor junior medical writers and team members involved in writing tasks.

Requirements

1. Minimum 3 years of experience in the pharmaceutical industry.
2. 3-5 years of regulatory and clinical medical writing experience.
3. Bachelor’s, Master’s, or Ph.D. in a scientific or medical discipline.
4. Significant Oncology experience.
5. Experience leading clinical study protocols as the lead author.
6. Proven ability to manage teams and meet deadlines for regulatory documents.
7. Experience with regulatory submissions, such as clinical study reports, is a plus.
8. Understanding of clinical data.
9. Exceptional writing skills.
10. Strong organizational skills and multitasking ability.
11. Expertise in MS Word, Excel, PowerPoint.
12. Experience as a project lead or team manager.
13. Knowledge of federal regulations, GCP, and ICH guidelines is advantageous.
14. Experience with orphan drug designations and PSP/PIPs is beneficial.

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