Senior Medical Writer Home Based - South Africa

Mms; Johannesburg; On-site; ZAR 50 000 - 90 000; Full time

Job summary

An innovative data-focused company seeks a motivated Medical Writer to join its South Africa team. This home-based role is perfect for a self-starting professional with a strong background in medical writing. You will be responsible for crafting clinical documents, ensuring scientific rigor, and maintaining timelines. With a focus on oncology and regulatory submissions, you will have the opportunity to work independently while collaborating with clients. This role promises a dynamic work environment where your expertise will contribute to impactful projects in the pharmaceutical industry.

Qualifications

• Minimum 3 years of experience in the pharmaceutical industry.
• Exceptional writing skills and organizational abilities required.
• Substantial oncology experience is essential.

Responsibilities

• Write and edit clinical development documents under minimal supervision.
• Evaluate and interpret medical literature for study design.
• Mentor medical writers and manage writing assignments.

Skills

Clinical Research

Technical Writing

Writing Skills

FDA Regulations

Document Management Systems

Research Experience

Biotechnology

Clinical Development

Clinical Trials

Microsoft PowerPoint

Education

Bachelor's in a scientific discipline

Master's in a scientific discipline

Ph.D. in a scientific discipline

Tools

MS Word

MS Excel

Adobe Acrobat

MS PowerPoint

Job description

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 www.mmsholdings.com or follow MMS on LinkedIn.

Senior Medical Writer

We are recruiting a Medical Writer to join our South Africa team. This is a home-based role, open to candidates anywhere in South Africa. We seek a motivated, self-starting professional with medical writing experience seeking a new challenge.

• Under minimal supervision, 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 but not limited to clinical protocols, investigator brochures, clinical study reports, subject consent forms, safety and efficacy summaries, Module 2.7.1-2.7.4, and 2.5 documents, presentation materials, and publications.
• Complete writing assignments promptly, maintaining timelines and workflow.
• Practice excellent internal and external customer service.
• Proficient in writing styles for various regulatory documents and familiar with client templates and style guides.
• Interact directly and independently with clients to coordinate project aspects; demonstrate competent communication skills.
• Contribute to or manage the production of interpretive guides.
• Proactively take ownership of assignments, consulting with team members and other departments as needed.
• Mentor medical writers and project team members involved in the writing process.

Requirements

• Minimum 3 years of experience in the pharmaceutical industry.
• At least 3-5 years of regulatory and clinical medical writing experience.
• Holding a Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
• Substantial oncology experience required.
• Experience as lead author on clinical study protocols.
• Experience managing teams and authoring regulatory documents under tight deadlines.
• Experience with regulatory submissions (clinical study reports) is a plus.
• Understanding of clinical data.
• Exceptional writing skills and organizational abilities.
• Proficiency in MS Word, Excel, PowerPoint, and related tools.
• Experience as a project lead or team manager.
• Knowledge of federal regulations, Good Clinical Practices, and ICH guidelines is advantageous.
• Experience with orphan drug designations and PSP/PIPs is a plus but not required.

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

Required Experience: Senior IC

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